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A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (B-FAST)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Alectinib
Atezolizumab
Pemetrexed
Cisplatin
Carboplatin
Gemcitabine
Entrectinib
Cobimetinib
Vemurafenib
Bevacizumab
GDC-6036
Docetaxel
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Measurable disease
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Adequate organ function
  • Life expectancy greater than or equal to (>/=) 12 weeks
  • For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception

Exclusion Criteria:

  • Inability to swallow oral medication
  • Women who are pregnant or lactating
  • Symptomatic, untreated CNS metastases
  • History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
  • Known human immunodeficiency virus (HIV) positivity or autoimmune deficiency syndrome (AIDS)-related illness
  • Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
  • Inability to comply with other requirements of the protocol

Sites / Locations

  • University of California San Diego
  • UC Davis; Comprehensive Cancer Center
  • Rocky Mountain Cancer Center
  • Eastern Connecticut Hematology and Oncology Associates; (ECHO)
  • SCRI Florida Cancer Specialists South
  • Florida Cancer Specialist, North Region
  • University Cancer & Blood Center, LLC; Research
  • Illinois Cancer Care
  • University of Kentucky; Markey Cancer Center
  • University of Michigan Comprehensive Cancer Center
  • Henry Ford Health System; Hematology/OncologyRecruiting
  • Comprehensive Cancer Centers of Nevada
  • Dartmouth Hitchcock Medical CenterRecruiting
  • Cancer Inst. of New Jersey
  • Montefiore Medical CenterRecruiting
  • Weill Cornell Medical College-New York Presbyterian Hospital
  • Ohio State University
  • Oregon HSU
  • St. Luke's University Health network
  • SCRI Tennessee Oncology Chattanooga
  • Tennessee Oncology PLLC - Nashville (20th Ave)Recruiting
  • Texas Oncology - South Austin
  • Oncology Consultants PA
  • Virginia Cancer Specialists, PC
  • University of Washington Seattle Cancer Care Alliance
  • Fundación CENIT para la Investigación en NeurocienciasRecruiting
  • Hospital ItalianoRecruiting
  • Hospital Britanico de Buenos AiresRecruiting
  • Centro Oncologico Riojano Integral (CORI)Recruiting
  • Royal North Shore Hospital; Department of Medical Oncology
  • The Prince Charles Hospital; Oncology Dept.
  • Ashford Cancer Center Research
  • Austin Hospital; Medical OncologyRecruiting
  • Sir Charles Gairdner Hospital
  • UZ BrusselRecruiting
  • Cliniques Universitaires St-Luc
  • UZ Leuven GasthuisbergRecruiting
  • Instituto Nacional de Cancer - INCa; OncologiaRecruiting
  • Oncosite - Centro de Pesquisa Clinica Em Oncologia LtdaRecruiting
  • Hospital Sao Lucas - PUCRSRecruiting
  • Instituto do Cancer do Estado de Sao Paulo - ICESPRecruiting
  • Cross Cancer InstituteRecruiting
  • CancerCare Manitoba; Department of Medical OncologyRecruiting
  • Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
  • William Osler Health System Brampton Civic HospitalRecruiting
  • London Health Sciences Centre · Victoria Hospital; Department of Medicine
  • Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer CenterRecruiting
  • Sunnybrook Health Sciences CentreRecruiting
  • Princess Margaret Cancer CenterRecruiting
  • Jewish General HospitalRecruiting
  • IUCPQ (Hôpital Laval)
  • Saskatoon Cancer CentreRecruiting
  • BiocenterRecruiting
  • Bradford Hill Centro de Investigaciones ClinicasRecruiting
  • Beijing Cancer HospitalRecruiting
  • Jilin Cancer HospitalRecruiting
  • Hunan Cancer HospitalRecruiting
  • The second Xiangya hospital of central south universityRecruiting
  • Sichuan Cancer HospitalRecruiting
  • West China Hospital - Sichuan UniversityRecruiting
  • The First Affiliated Hospital of Guangzhou Medical University PharmacyRecruiting
  • Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer departmentRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • Shandong Cancer HospitalRecruiting
  • The Second Affiliated Hospital to Nanchang UniversityRecruiting
  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical SchoolRecruiting
  • Fudan Unviversity Shanghai Cancer CenterRecruiting
  • Xiehe Hospital, Tongji Medical College Huazhong University of Science & TechnologyRecruiting
  • First Affiliated Hospital of Medical College of Xi'an Jiaotong UniversityRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Clinica CIMCARecruiting
  • Institut Bergonie CLCC Bordeaux
  • Centre Francois Baclesse; Radiologie
  • Centre Oscar Lambret
  • Centre Léon BérardRecruiting
  • Hopital Caremeau; PneumologieRecruiting
  • Hopital Bichat Claude Bernard; Oncologie Serv.
  • Hôpital Européen Georges PompidouRecruiting
  • Hopital Tenon;Pneumologie
  • CHU Poitiers
  • Hopital Pontchaillou
  • CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
  • Hopital Bretonneau; Pneumologie Oncologie
  • Hopital Robert Schuman; PneumologieRecruiting
  • Klinikum Chemnitz gGmbH
  • Universitätsklinikum Düsseldorf; Klinik für Kardiologie, Pneumologie und Angiologie
  • Universitätsklinikum Essen; Innere Klinik (Tumorforschung)
  • Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie
  • Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
  • Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
  • Thoraxklinik Heidelberg gGmbH
  • HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed
  • Pamela Youde Nethersole Eastern Hospital
  • Queen Mary Hospital; Medicine & Respiratory
  • Prince of Wales Hosp; Dept. Of Clinical OncRecruiting
  • Soroka Medical Center; Oncology DeptRecruiting
  • Rambam Health Care Campus; OncologyRecruiting
  • Meir Medical Center; OncologyRecruiting
  • Rabin MC; Davidof Center - Oncology InstituteRecruiting
  • Chaim Sheba Medical Center; Oncology DeptRecruiting
  • Sourasky / Ichilov Hospital; Dept. of OncologyRecruiting
  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. PascaleRecruiting
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia MedicaRecruiting
  • Irccs Centro Di Riferimento Oncologico (CRO)Recruiting
  • Azienda Ospedaliera San Camillo ForlaniniRecruiting
  • Asst Papa Giovanni XXIII; Oncologia MedicaRecruiting
  • ASST di Cremona - Azienda Socio Sanitaria Territoriale di CremonaRecruiting
  • Irccs Istituto Europeo di Oncologia (IEO); Divisione di OncologiaRecruiting
  • Asst Di MonzaRecruiting
  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia ToracicaRecruiting
  • Fujita Health University Hospital
  • National Cancer Center Hospital East
  • Shikoku Cancer Center
  • National Hospital Organization Kyushu Medical Center
  • National Hospital Organization Kyushu Cancer Center
  • Kyushu University Hospital
  • Hiroshima University Hospital
  • Kanazawa University Hospital
  • Kanagawa Cancer Center
  • University Hospital Kyoto Prefectural University of Medicine
  • Kyoto University Hospital
  • Sendai Kousei Hospital
  • Tohoku University Hospital
  • Niigata University Medical & Dental Hospital
  • Niigata Cancer Center Hospital
  • Okayama University Hospital
  • Kindai University Hospital
  • Saga University Hospital
  • Shizuoka Cancer Center
  • Juntendo University Hospital
  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
  • The Cancer Institute Hospital of JFCR
  • Kyorin University Hospital
  • Wakayama Medical University Hospital
  • National Hospital Organization Yamaguchi - Ube Medical Center
  • National Cancer CenterRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Yonsei University Health System/Severance HospitalRecruiting
  • Hospital Angeles TijuanaRecruiting
  • Health Pharma Professional ResearchRecruiting
  • AVIX Investigación Clínica S.CRecruiting
  • Oncologico Potosino
  • UMCG
  • Erasmus MC
  • Auckland City HospitalRecruiting
  • Hemato Oncología de Panamá Especializada
  • Hospital Nacional Edgardo Rebagliati Martins; OncologiaRecruiting
  • Instituto Nacional de Enfermedades NeoplasicasRecruiting
  • Clinica Ricardo PalmaRecruiting
  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i RadioterapiiRecruiting
  • Krakowski Szpital Specjalistyczny im sw.Jana Pawla IIRecruiting
  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapiiRecruiting
  • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial IiiRecruiting
  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w PoznaniuRecruiting
  • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki PiersRecruiting
  • Moscow City Oncology Hospital #62
  • Principal Military Clinical Hospital n.a. N.N. Burdenko
  • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)Recruiting
  • Saint-Petersburg City Clinical Oncology Dispensary
  • Clinical Oncology Dispensary; Chemotherapy
  • Clinical Center of SerbiaRecruiting
  • University Hospital Medical Center Bezanijska kosaRecruiting
  • Clinical Center Nis
  • Institute for Pulmonary Diseases of Vojvodina; Clinic for Pulmonary OncologyRecruiting
  • National University Hospital; National University Cancer Institute, Singapore (NCIS)
  • National Cancer Centre; Medical OncologyRecruiting
  • Insititut Catala D'OncologiaRecruiting
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de OncologiaRecruiting
  • Hospital Universitario Puerta de Hierro; Servicio de OncologiaRecruiting
  • Hospital Quiron de Madrid; Servicio de OncologiaRecruiting
  • Clinica Universitaria de Navarra; Servicio de OncologiaRecruiting
  • Hospital General Univ. de AlicanteRecruiting
  • Hospital Universitari Vall d'Hebron; OncologyRecruiting
  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología
  • ICO Badalona - Hospital Germans Trias i PujolRecruiting
  • Hospital General Universitario Gregorio Marañon; Servicio de OncologiaRecruiting
  • Hospital Ramon y Cajal; Servicio de OncologiaRecruiting
  • Hospital Universitario 12 de Octubre; Servicio de OncologiaRecruiting
  • Centro Integral Oncologico Clara Campal; Servicio de OncologíaRecruiting
  • Hospital Regional Universitario Carlos Haya; Servicio de OncologiaRecruiting
  • Hospital Universitario Virgen del Rocio; Servicio de OncologiaRecruiting
  • Hospital Clínico Universitario de Valencia; Servicio de OncologíaRecruiting
  • Kaohsiung Chang Gung Memorial Hospital; Dept of Internal MedicineRecruiting
  • National Taiwan Uni Hospital; Internal MedicineRecruiting
  • Taipei Medical University HospitalRecruiting
  • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic OncologyRecruiting
  • Chang Gung Medical Foundation - Linkou; Chest DeptRecruiting
  • Chulalongkorn Hospital; Medical OncologyRecruiting
  • Ramathibodi Hospital; Dept of Med.-Div. of Med. OncRecruiting
  • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. OncologyRecruiting
  • Prince of Songkla University; Division of Pulmonary Disease, Department of MedicineRecruiting
  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical OncologyRecruiting
  • Akdeniz University Medical Faculty; Medical Oncology DepartmentRecruiting
  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology DepartmentRecruiting
  • Medipol University Medical Faculty; Oncology DepartmentRecruiting
  • Marmara University Pendik Training and Research Hospital; Medikal OnkolojiRecruiting
  • Medikal Park Izmir HospitalRecruiting
  • Hacettepe Uni Medical Faculty Hospital; Oncology DeptRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort A: Alectinib 600 Milligrams (mg)

Cohort B: Dose Finding Phase (DFP) Alectinib

Cohort B: Dose Expansion Phase (DEP) Alectinib

Cohort C: Atezolizumab 1200 mg

Cohort C: Pemetrexed, Cisplatin or Carboplatin

Cohort C: Gemcitabine, Cisplatin or Carboplatin

Cohort D: Entrectinib 600 Milligrams (mg)

Cohort E: Atezolizumab, Vemurafenib, and Cobimetinib

Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and Pemetrexed

Cohort G: GDC-6036 or Docetaxel

Arm Description

This cohort includes participants with anaplastic lymphoma kinase (ALK) positive NSCLC. Participants will receive alectinib 600 mg orally twice in a day (BID) until disease progression, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort A is complete.

This cohort includes participants with rearranged during transfection (RET) positive NSCLC. Participants may receive alectinib 900 or 1200 mg orally BID until disease progression, unacceptable toxicity, withdrawal of consent or death if the recommended phase 2 dose (RP2D) is not established in any other clinical study. Participants may receive 750 mg or 600 mg, if it is unsafe to pursue the higher starting dose. Enrollment to Cohort B is complete.

This cohort includes participants with RET positive NSCLC. Participants will receive alectinib at the RP2D established in the DFP of Cohort B or a separate clinical study. Participants will continue receiving study treatment until disease progression, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort B is complete.

This cohort includes participants with bTMB positive NSCLC. Participants will receive atezolizumab at a dose of 1200 mg administered by IV infusion every 21 days (Q21D) until disease progression, loss of clinical benefit, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort C is complete.

This cohort includes participants with bTMB positive, non-squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Carboplatin at a dose of area under the concentration-time curve (AUC) of 5 or 6 IV or cisplatin at a dose of 75 milligrams per meter square (mg/m^2) IV on Day 1 of each cycle combined with pemetrexed at a dose of 500 mg/m^2 IV on Day 1 of each cycle. Pemetrexed may be continued as maintenance therapy every 21 days (Q21D) as per local standard of care. Enrollment to Cohort C is complete.

This cohort includes participants with bTMB positive, squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of every cycle and cisplatin 75 mg/m^2 IV on Day 1 Q21D or gemcitabine 1000 mg/m^2 IV on Days 1 and 8 of every cycle and carboplatin AUC 5 IV on Day 1 Q21D. Enrollment to Cohort C is complete.

This cohort includes participants with c-ros oncogene 1 positive (ROS1+) NSCLC. Participants will receive entrectinib 600 mg orally once a day (QD) until disease progression, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort D is complete.

This cohort includes participants with BRAF V600 mutation. Participants will receive: atezolizumab 1680 mg IV Q4W after the run-in period; cobimetinib 60 mg orally (PO) QD on Days 1-21 of each cycle during the run-in and triple-combination periods; and vemurafenib 960 mg PO twice daily (BID) on Days 1-21 of the initial run-in period, then 720 mg PO BID on Days 1-22 of the initial run-in period and on Days 1-28 of each cycle during the triple-combination period. Enrollment to Cohort E is complete.

This cohort includes participants with EGFR exon 20+ NSCLC. Participants will receive atezolizumab + bevacizumab + carboplatin + pemetrexed for 4 or 6 induction cycles (cycle = 21 days). After induction therapy, participants will continue maintenance treatment with atezolizumab + bevacizumab + pemetrexed until disease progression, unacceptable toxicity, withdrawal of consent, or death. Enrollment to Cohort F is complete.

This cohort includes participants with KRAS G12C mutation. Participants will receive GDC-6036 PO QD or IV docetaxel Q3W (75 mg/m^2) until disease progression or unacceptable toxicity

Outcomes

Primary Outcome Measures

Cohort A: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1
Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on RECIST v1.1 in bTMB PP1
Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1
Cohort E: Time in Response (TIR) as Assessed by the Investigator Based on RECIST v1.1
Cohort F: Investigator-Assessed Objective Response Rate (ORR) Based on RECIST v1.1
Cohort G: PFS as Determined by Blinded Independent Central Review (BICR) Based on RECIST v1.1

Secondary Outcome Measures

All Cohorts: Duration of Response (DOR) as Assessed by the Investigator Based on RECIST v1.1
Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by the Investigator Based on RECIST v1.1
Cohorts A, B, D, F, G: PFS as Assessed by the Investigator Based on RECIST v1.1
Cohorts A-F: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on RECIST v1.1
Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by IRF Based on RECIST v1.1
Cohorts A-F: PFS as Assessed by IRF Based on RECIST v1.1
Cohorts A-F: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on RECIST v1.1
All Cohorts: Overall Survival (OS)
All Cohorts: Percentage of Participants with Adverse Events (AEs)
Cohorts A, B, D, E, F: Percentage of Participants with Improvement Compared with Baseline in Total Severity Symptom Score as Measured by Symptoms in Lung Cancer (SILC) Scale in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain)
Cohorts A-F: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by the SILC Scale
Cohorts C, E, F: Change from Baseline in Patient-Reported Lung Cancer Symptom (Cough, Dyspnea, Chest pain) Score as Measured by the SILC Scale
Cohorts A-F: Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
Cohorts A, B, D, E, F: Change from Baseline in HRQoL Scores as Measured by the SILC Scale
All Cohorts: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the EORTC QLQ-C30
Cohorts A, B, D, E, F: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the SILC Scale
All Cohorts: Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
Cohort B: Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib
DFP: Dose-Finding Phase; DEP: Dose-Expanding Phase.
Cohort B: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of Alectinib
Cohort B: Time to Reach Cmax (Tmax) of Alectinib
Cohort B: Half-Life (t1/2) of Alectinib
Cohort B: Metabolite to Parent Exposure Ratio for AUC0-last
Cohort B: Metabolite to Parent Exposure Ratio for Cmax
Cohort C: Percentage of Participants with Objective Response as Assessed by the Investigator Based on RECIST v1.1
Cohort C: Percentage of Participants Free from Disease Progression as Assessed by the Investigator Based on RECIST v1.1 at Months 6 and 12
Cohort C: PFS as Assessed by the Investigator based on RECIST v1.1 in bTMB PP2
Cohort C: OS in bTMB PP2
Cohort D: Time to CNS progression as Assessed by the Investigator Based on RECIST v1.1
Cohort D: Time to CNS progression as Assessed by the IRF Based on RECIST v1.1
Cohort D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-C30
Cohort D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-BN20
Cohort D: Mean Plasma Concentration of Entrectinib
Cohort D: Mean Plasma Concentration of Entrectinib Metabolite M5
Cohort E: TIR as Assessed by the Investigator Based on RECIST v1.1
Cohort E: TIR as Assessed by IRF
Cohorts E, F: Serum Concentration of Atezolizumab
Cohorts E, F: Change from Baseline in Anti-Drug Antibodies (ADAs)
Cohorts E, F: Time to Confirmed Deterioration (TTCD) in Participant-Reported Lung Cancer Symptoms of Cough, Dyspnea, and Chest Pain, as Measured by the Symptoms in Lung Cancer (SILC)
Cohorts E, F: Proportion of Participants who Improve Compared with Baseline in Participant-Reported Lung Cancer Symptoms of Cough, Dyspnea, and Chest Pain, as Measured by the SILC
Cohort G: Objective Response Rate (ORR) as Assessed by the Investigator Based on RECIST v1.1
Cohort G: TTCD on the EORTC QLQ-C30 Physical Functioning and Role Functioning Scales
Cohort G: Proportion of Participants Reporting Clinically Meaningful Deterioration in Fatigue, Chest Pain, Physical and Role Functioning as Measured by the EORTC QLQ-LC13 and QLQ-C30 Questionnaires
Cohort G: Change from Baseline in Fatigue, Chest Pain, Physical and Role Functioning as Measured by the EORTC QLQ-LC13 and QLQ-C30 Questionnaires
Cohort G: Tolerability of GDC-6036 or Docetaxel as Assessed by the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Cohort G: Plasma Concentration of GDC-6036

Full Information

First Posted
June 5, 2017
Last Updated
October 4, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03178552
Brief Title
A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)
Acronym
B-FAST
Official Title
A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2017 (Actual)
Primary Completion Date
April 27, 2024 (Anticipated)
Study Completion Date
April 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: Alectinib 600 Milligrams (mg)
Arm Type
Experimental
Arm Description
This cohort includes participants with anaplastic lymphoma kinase (ALK) positive NSCLC. Participants will receive alectinib 600 mg orally twice in a day (BID) until disease progression, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort A is complete.
Arm Title
Cohort B: Dose Finding Phase (DFP) Alectinib
Arm Type
Experimental
Arm Description
This cohort includes participants with rearranged during transfection (RET) positive NSCLC. Participants may receive alectinib 900 or 1200 mg orally BID until disease progression, unacceptable toxicity, withdrawal of consent or death if the recommended phase 2 dose (RP2D) is not established in any other clinical study. Participants may receive 750 mg or 600 mg, if it is unsafe to pursue the higher starting dose. Enrollment to Cohort B is complete.
Arm Title
Cohort B: Dose Expansion Phase (DEP) Alectinib
Arm Type
Experimental
Arm Description
This cohort includes participants with RET positive NSCLC. Participants will receive alectinib at the RP2D established in the DFP of Cohort B or a separate clinical study. Participants will continue receiving study treatment until disease progression, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort B is complete.
Arm Title
Cohort C: Atezolizumab 1200 mg
Arm Type
Experimental
Arm Description
This cohort includes participants with bTMB positive NSCLC. Participants will receive atezolizumab at a dose of 1200 mg administered by IV infusion every 21 days (Q21D) until disease progression, loss of clinical benefit, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort C is complete.
Arm Title
Cohort C: Pemetrexed, Cisplatin or Carboplatin
Arm Type
Active Comparator
Arm Description
This cohort includes participants with bTMB positive, non-squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Carboplatin at a dose of area under the concentration-time curve (AUC) of 5 or 6 IV or cisplatin at a dose of 75 milligrams per meter square (mg/m^2) IV on Day 1 of each cycle combined with pemetrexed at a dose of 500 mg/m^2 IV on Day 1 of each cycle. Pemetrexed may be continued as maintenance therapy every 21 days (Q21D) as per local standard of care. Enrollment to Cohort C is complete.
Arm Title
Cohort C: Gemcitabine, Cisplatin or Carboplatin
Arm Type
Active Comparator
Arm Description
This cohort includes participants with bTMB positive, squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of every cycle and cisplatin 75 mg/m^2 IV on Day 1 Q21D or gemcitabine 1000 mg/m^2 IV on Days 1 and 8 of every cycle and carboplatin AUC 5 IV on Day 1 Q21D. Enrollment to Cohort C is complete.
Arm Title
Cohort D: Entrectinib 600 Milligrams (mg)
Arm Type
Experimental
Arm Description
This cohort includes participants with c-ros oncogene 1 positive (ROS1+) NSCLC. Participants will receive entrectinib 600 mg orally once a day (QD) until disease progression, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort D is complete.
Arm Title
Cohort E: Atezolizumab, Vemurafenib, and Cobimetinib
Arm Type
Experimental
Arm Description
This cohort includes participants with BRAF V600 mutation. Participants will receive: atezolizumab 1680 mg IV Q4W after the run-in period; cobimetinib 60 mg orally (PO) QD on Days 1-21 of each cycle during the run-in and triple-combination periods; and vemurafenib 960 mg PO twice daily (BID) on Days 1-21 of the initial run-in period, then 720 mg PO BID on Days 1-22 of the initial run-in period and on Days 1-28 of each cycle during the triple-combination period. Enrollment to Cohort E is complete.
Arm Title
Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and Pemetrexed
Arm Type
Experimental
Arm Description
This cohort includes participants with EGFR exon 20+ NSCLC. Participants will receive atezolizumab + bevacizumab + carboplatin + pemetrexed for 4 or 6 induction cycles (cycle = 21 days). After induction therapy, participants will continue maintenance treatment with atezolizumab + bevacizumab + pemetrexed until disease progression, unacceptable toxicity, withdrawal of consent, or death. Enrollment to Cohort F is complete.
Arm Title
Cohort G: GDC-6036 or Docetaxel
Arm Type
Experimental
Arm Description
This cohort includes participants with KRAS G12C mutation. Participants will receive GDC-6036 PO QD or IV docetaxel Q3W (75 mg/m^2) until disease progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Alectinib
Other Intervention Name(s)
RO5424802
Intervention Description
Participants will receive 600 mg BID (Cohort A); 900, 1200, or 750 mg BID (Cohort B) or RP2D BID; orally until disease progression, unacceptable toxicity, withdrawal of consent or death.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
RO5541267
Intervention Description
Participants will receive atezolizumab 1200 mg IV infusion Q21D (Cohorts C and F) or 1680 mg IV infusion Q4W starting on Day 29 (Cohort E).
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Participants will receive pemetrexed 500 mg/m^2 IV infusion on Day 1 Q21D.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Participants will receive cisplatin 75 mg/m^2 IV on Day 1 Q21D.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Participants will receive gemcitabine 1000 or 1250 mg/m^2 on Days 1 and 8 of every cycle (1 Cycle=21 days).
Intervention Type
Drug
Intervention Name(s)
Entrectinib
Other Intervention Name(s)
RO7102122
Intervention Description
Participants will receive entrectinib 600 mg orally QD.
Intervention Type
Drug
Intervention Name(s)
Cobimetinib
Other Intervention Name(s)
RO5514041
Intervention Description
Participants will receive 60 mg PO QD on Days 1-21 of the initial run-in and triple-combination periods.
Intervention Type
Drug
Intervention Name(s)
Vemurafenib
Other Intervention Name(s)
RO5185426
Intervention Description
Participants will receive 960 mg PO BID on Days 1-21 of the initial run-in period, and 720 mg PO BID on Days 22-28 of the initial run-in period and on Days 1-28 of each cycle during the triple-combination period.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
RO4876646
Intervention Description
Participants will receive 15 mg/kg of IV bevacizumab on Day 1 of each 21-day cycle during the induction and maintenance periods.
Intervention Type
Drug
Intervention Name(s)
GDC-6036
Other Intervention Name(s)
RO7435846
Intervention Description
Participants will receive GDC-6036 PO QD until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Participants will receive IV docetaxel Q3W (75 mg/m^2) until disease progression or unacceptable toxicity
Primary Outcome Measure Information:
Title
Cohort A: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on RECIST v1.1 in bTMB PP1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohort E: Time in Response (TIR) as Assessed by the Investigator Based on RECIST v1.1
Time Frame
Month 12
Title
Cohort F: Investigator-Assessed Objective Response Rate (ORR) Based on RECIST v1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohort G: PFS as Determined by Blinded Independent Central Review (BICR) Based on RECIST v1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Secondary Outcome Measure Information:
Title
All Cohorts: Duration of Response (DOR) as Assessed by the Investigator Based on RECIST v1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by the Investigator Based on RECIST v1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohorts A, B, D, F, G: PFS as Assessed by the Investigator Based on RECIST v1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohorts A-F: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on RECIST v1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by IRF Based on RECIST v1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohorts A-F: PFS as Assessed by IRF Based on RECIST v1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohorts A-F: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on RECIST v1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
All Cohorts: Overall Survival (OS)
Time Frame
Baseline up to approximately 6 years
Title
All Cohorts: Percentage of Participants with Adverse Events (AEs)
Time Frame
Baseline up to approximately 6 years
Title
Cohorts A, B, D, E, F: Percentage of Participants with Improvement Compared with Baseline in Total Severity Symptom Score as Measured by Symptoms in Lung Cancer (SILC) Scale in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain)
Time Frame
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Title
Cohorts A-F: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by the SILC Scale
Time Frame
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Title
Cohorts C, E, F: Change from Baseline in Patient-Reported Lung Cancer Symptom (Cough, Dyspnea, Chest pain) Score as Measured by the SILC Scale
Time Frame
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Title
Cohorts A-F: Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
Time Frame
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Title
Cohorts A, B, D, E, F: Change from Baseline in HRQoL Scores as Measured by the SILC Scale
Time Frame
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Title
All Cohorts: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the EORTC QLQ-C30
Time Frame
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Title
Cohorts A, B, D, E, F: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the SILC Scale
Time Frame
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Title
All Cohorts: Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
Time Frame
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Title
Cohort B: Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time Frame
Day 1 to Day 28 of Cycle 1 (cycle length = 28 days)
Title
Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib
Description
DFP: Dose-Finding Phase; DEP: Dose-Expanding Phase.
Time Frame
DFP: pre-dose (0 hours [hr]) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
Title
Cohort B: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of Alectinib
Time Frame
DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
Title
Cohort B: Time to Reach Cmax (Tmax) of Alectinib
Time Frame
DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
Title
Cohort B: Half-Life (t1/2) of Alectinib
Time Frame
DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
Title
Cohort B: Metabolite to Parent Exposure Ratio for AUC0-last
Time Frame
DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
Title
Cohort B: Metabolite to Parent Exposure Ratio for Cmax
Time Frame
DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
Title
Cohort C: Percentage of Participants with Objective Response as Assessed by the Investigator Based on RECIST v1.1
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohort C: Percentage of Participants Free from Disease Progression as Assessed by the Investigator Based on RECIST v1.1 at Months 6 and 12
Time Frame
Months 6, 12
Title
Cohort C: PFS as Assessed by the Investigator based on RECIST v1.1 in bTMB PP2
Time Frame
Baseline up to disease progression or death (up to approximately 6 years)
Title
Cohort C: OS in bTMB PP2
Time Frame
Baseline up to approximately 6 years
Title
Cohort D: Time to CNS progression as Assessed by the Investigator Based on RECIST v1.1
Time Frame
Baseline up to CNS progression (up to approximately 6 years)
Title
Cohort D: Time to CNS progression as Assessed by the IRF Based on RECIST v1.1
Time Frame
Baseline up to CNS progression (up to approximately 6 years)
Title
Cohort D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-C30
Time Frame
Baseline, every 4 weeks until disease progression, up to approximately 6 years
Title
Cohort D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-BN20
Time Frame
Baseline, every 4 weeks until disease progression, up to approximately 6 years
Title
Cohort D: Mean Plasma Concentration of Entrectinib
Time Frame
Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days).
Title
Cohort D: Mean Plasma Concentration of Entrectinib Metabolite M5
Time Frame
Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days).
Title
Cohort E: TIR as Assessed by the Investigator Based on RECIST v1.1
Time Frame
Month 9
Title
Cohort E: TIR as Assessed by IRF
Time Frame
Month 12
Title
Cohorts E, F: Serum Concentration of Atezolizumab
Time Frame
Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days)
Title
Cohorts E, F: Change from Baseline in Anti-Drug Antibodies (ADAs)
Time Frame
Baseline up to approximately 6 years
Title
Cohorts E, F: Time to Confirmed Deterioration (TTCD) in Participant-Reported Lung Cancer Symptoms of Cough, Dyspnea, and Chest Pain, as Measured by the Symptoms in Lung Cancer (SILC)
Time Frame
Baseline up to approximately 6 years
Title
Cohorts E, F: Proportion of Participants who Improve Compared with Baseline in Participant-Reported Lung Cancer Symptoms of Cough, Dyspnea, and Chest Pain, as Measured by the SILC
Time Frame
Baseline up to approximately 6 years
Title
Cohort G: Objective Response Rate (ORR) as Assessed by the Investigator Based on RECIST v1.1
Time Frame
Baseline up to approximately 6 years
Title
Cohort G: TTCD on the EORTC QLQ-C30 Physical Functioning and Role Functioning Scales
Time Frame
Baseline up to approximately 6 years
Title
Cohort G: Proportion of Participants Reporting Clinically Meaningful Deterioration in Fatigue, Chest Pain, Physical and Role Functioning as Measured by the EORTC QLQ-LC13 and QLQ-C30 Questionnaires
Time Frame
Cycle 5 (1 cycle = 21 or 28 days)
Title
Cohort G: Change from Baseline in Fatigue, Chest Pain, Physical and Role Functioning as Measured by the EORTC QLQ-LC13 and QLQ-C30 Questionnaires
Time Frame
Cycle 5 (1 cycle = 21 or 28 days)
Title
Cohort G: Tolerability of GDC-6036 or Docetaxel as Assessed by the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time Frame
Cycles 1-3 (1 cycle = 21 days)
Title
Cohort G: Plasma Concentration of GDC-6036
Time Frame
Cycles 1-5 (1 cycle = 21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Measurable disease Adequate recovery from most recent systemic or local treatment for cancer Adequate organ function Life expectancy greater than or equal to (>/=) 12 weeks For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception Exclusion Criteria: Inability to swallow oral medication Women who are pregnant or lactating Symptomatic, untreated CNS metastases History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina Known human immunodeficiency virus (HIV) positivity or autoimmune deficiency syndrome (AIDS)-related illness Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study Inability to comply with other requirements of the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BO29554 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Withdrawn
Facility Name
UC Davis; Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Eastern Connecticut Hematology and Oncology Associates; (ECHO)
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Individual Site Status
Withdrawn
Facility Name
SCRI Florida Cancer Specialists South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Individual Site Status
Completed
Facility Name
Florida Cancer Specialist, North Region
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Completed
Facility Name
University Cancer & Blood Center, LLC; Research
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Individual Site Status
Withdrawn
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Kentucky; Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Terminated
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Withdrawn
Facility Name
Henry Ford Health System; Hematology/Oncology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Inst. of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Withdrawn
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medical College-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212-3153
Country
United States
Individual Site Status
Withdrawn
Facility Name
Oregon HSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
St. Luke's University Health network
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Individual Site Status
Terminated
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Completed
Facility Name
Tennessee Oncology PLLC - Nashville (20th Ave)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Oncology - South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Withdrawn
Facility Name
Oncology Consultants PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Withdrawn
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Washington Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Withdrawn
Facility Name
Fundación CENIT para la Investigación en Neurociencias
City
Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano
City
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Britanico de Buenos Aires
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1284AEB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Oncologico Riojano Integral (CORI)
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Royal North Shore Hospital; Department of Medical Oncology
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
The Prince Charles Hospital; Oncology Dept.
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Completed
Facility Name
Ashford Cancer Center Research
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Individual Site Status
Terminated
Facility Name
Austin Hospital; Medical Oncology
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Withdrawn
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Active, not recruiting
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Cancer - INCa; Oncologia
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20560-120
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
City
Ijui
State/Province
RS
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto do Cancer do Estado de Sao Paulo - ICESP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Name
CancerCare Manitoba; Department of Medical Oncology
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
Individual Site Status
Completed
Facility Name
William Osler Health System Brampton Civic Hospital
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Individual Site Status
Recruiting
Facility Name
London Health Sciences Centre · Victoria Hospital; Department of Medicine
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Completed
Facility Name
Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Name
IUCPQ (Hôpital Laval)
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Completed
Facility Name
Saskatoon Cancer Centre
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
SK S7N 4H4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Biocenter
City
Concepción
Country
Chile
Individual Site Status
Recruiting
Facility Name
Bradford Hill Centro de Investigaciones Clinicas
City
Recoleta
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Jilin Cancer Hospital
City
Changchun
ZIP/Postal Code
132013
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha CITY
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
The second Xiangya hospital of central south university
City
Changsha City
ZIP/Postal Code
410100
Country
China
Individual Site Status
Recruiting
Facility Name
Sichuan Cancer Hospital
City
Chengdu City
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital - Sichuan University
City
Chengdu City
ZIP/Postal Code
610047
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Guangzhou Medical University Pharmacy
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
City
Hangzhou City
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital to Nanchang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
City
Nanjing City
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Name
Fudan Unviversity Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
City
Xi'an
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Name
Clinica CIMCA
City
San José
ZIP/Postal Code
10103
Country
Costa Rica
Individual Site Status
Recruiting
Facility Name
Institut Bergonie CLCC Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Francois Baclesse; Radiologie
City
Caen
ZIP/Postal Code
14076
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Caremeau; Pneumologie
City
Nimes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Bichat Claude Bernard; Oncologie Serv.
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Withdrawn
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75908
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Tenon;Pneumologie
City
Paris
ZIP/Postal Code
75970
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Completed
Facility Name
Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique
City
Toulouse cedex 9
ZIP/Postal Code
31100
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Bretonneau; Pneumologie Oncologie
City
Tours
ZIP/Postal Code
37044
Country
France
Individual Site Status
Withdrawn
Facility Name
Hopital Robert Schuman; Pneumologie
City
Vantoux
ZIP/Postal Code
57070
Country
France
Individual Site Status
Recruiting
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum Düsseldorf; Klinik für Kardiologie, Pneumologie und Angiologie
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum Essen; Innere Klinik (Tumorforschung)
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Completed
Facility Name
Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Individual Site Status
Completed
Facility Name
Thoraxklinik Heidelberg gGmbH
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Completed
Facility Name
HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Pamela Youde Nethersole Eastern Hospital
City
Hong Kong
ZIP/Postal Code
Chai Wan
Country
Hong Kong
Individual Site Status
Withdrawn
Facility Name
Queen Mary Hospital; Medicine & Respiratory
City
Hong Kong
Country
Hong Kong
Individual Site Status
Active, not recruiting
Facility Name
Prince of Wales Hosp; Dept. Of Clinical Onc
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Soroka Medical Center; Oncology Dept
City
Beer Sheva
ZIP/Postal Code
8410100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus; Oncology
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center; Oncology
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin MC; Davidof Center - Oncology Institute
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Chaim Sheba Medical Center; Oncology Dept
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sourasky / Ichilov Hospital; Dept. of Oncology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
City
Meldola
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Centro Di Riferimento Oncologico (CRO)
City
Aviano
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
State/Province
Lazio
ZIP/Postal Code
151
Country
Italy
Individual Site Status
Recruiting
Facility Name
Asst Papa Giovanni XXIII; Oncologia Medica
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Asst Di Monza
City
Monza
State/Province
Lombardia
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica
City
Orbassano (TO)
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fujita Health University Hospital
City
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Completed
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Shikoku Cancer Center
City
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Hospital Organization Kyushu Medical Center
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Individual Site Status
Completed
Facility Name
National Hospital Organization Kyushu Cancer Center
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Completed
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Completed
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Completed
Facility Name
Kanazawa University Hospital
City
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Completed
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Sendai Kousei Hospital
City
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tohoku University Hospital
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Individual Site Status
Completed
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Completed
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Completed
Facility Name
Saga University Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Shizuoka Cancer Center
City
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Completed
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
City
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Completed
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kyorin University Hospital
City
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Individual Site Status
Completed
Facility Name
Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Completed
Facility Name
National Hospital Organization Yamaguchi - Ube Medical Center
City
Yamaguchi
ZIP/Postal Code
755-0241
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Yonsei University Health System/Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Angeles Tijuana
City
Tijuana
State/Province
BAJA California
ZIP/Postal Code
22010
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Health Pharma Professional Research
City
Cdmx
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
AVIX Investigación Clínica S.C
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Oncologico Potosino
City
San Luis Potosí
State/Province
SAN LUIS Potosi
ZIP/Postal Code
78209
Country
Mexico
Individual Site Status
Completed
Facility Name
UMCG
City
NL -groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Hemato Oncología de Panamá Especializada
City
Panama City
ZIP/Postal Code
0801
Country
Panama
Individual Site Status
Completed
Facility Name
Hospital Nacional Edgardo Rebagliati Martins; Oncologia
City
Lima
ZIP/Postal Code
11
Country
Peru
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Individual Site Status
Recruiting
Facility Name
Clinica Ricardo Palma
City
San Isidro
ZIP/Postal Code
Lima 27
Country
Peru
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakowski Szpital Specjalistyczny im sw.Jana Pawla II
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Individual Site Status
Recruiting
Facility Name
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Individual Site Status
Recruiting
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Moscow City Oncology Hospital #62
City
Moscovskaya Oblast
State/Province
Moskovskaja Oblast
ZIP/Postal Code
143423
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Principal Military Clinical Hospital n.a. N.N. Burdenko
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
105229
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
City
Saint-Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Saint-Petersburg City Clinical Oncology Dispensary
City
Sankt-peterburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Clinical Oncology Dispensary; Chemotherapy
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
University Hospital Medical Center Bezanijska kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Center Nis
City
NIS
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Completed
Facility Name
Institute for Pulmonary Diseases of Vojvodina; Clinic for Pulmonary Oncology
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Individual Site Status
Recruiting
Facility Name
National University Hospital; National University Cancer Institute, Singapore (NCIS)
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Completed
Facility Name
National Cancer Centre; Medical Oncology
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Insititut Catala D'Oncologia
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Quiron de Madrid; Servicio de Oncologia
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universitaria de Navarra; Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Univ. de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron; Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Completed
Facility Name
ICO Badalona - Hospital Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centro Integral Oncologico Clara Campal; Servicio de Oncología
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Valencia; Servicio de Oncología
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan Uni Hospital; Internal Medicine
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation - Linkou; Chest Dept
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chulalongkorn Hospital; Medical Oncology
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Akdeniz University Medical Faculty; Medical Oncology Department
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
City
Edirne
ZIP/Postal Code
22770
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medipol University Medical Faculty; Oncology Department
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Marmara University Pendik Training and Research Hospital; Medikal Onkoloji
City
Istanbul
ZIP/Postal Code
34890
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medikal Park Izmir Hospital
City
Kar??yaka
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
City
Sihhiye/Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35995953
Citation
Peters S, Dziadziuszko R, Morabito A, Felip E, Gadgeel SM, Cheema P, Cobo M, Andric Z, Barrios CH, Yamaguchi M, Dansin E, Danchaivijitr P, Johnson M, Novello S, Mathisen MS, Shagan SM, Schleifman E, Wang J, Yan M, Mocci S, Voong D, Fabrizio DA, Shames DS, Riehl T, Gandara DR, Mok T. Atezolizumab versus chemotherapy in advanced or metastatic NSCLC with high blood-based tumor mutational burden: primary analysis of BFAST cohort C randomized phase 3 trial. Nat Med. 2022 Sep;28(9):1831-1839. doi: 10.1038/s41591-022-01933-w. Epub 2022 Aug 22.
Results Reference
derived

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

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