search
Back to results

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer (IMforte)

Primary Purpose

Small-Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Lurbinectedin
Carboplatin
Etoposide
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria for the Induction Phase:

  • ECOG PS of 0 or 1
  • No prior systemic therapy for ES-SCLC
  • Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
  • Histologically or cytologically confirmed ES-SCLC
  • Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab
  • Measurable disease, as defined by RECIST v1.1
  • Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening

Exclusion Criteria for the Induction Phase:

  • Presence or history of CNS metastases
  • Active or history of autoimmune disease or deficiency
  • History of malignancies other than SCLC within 5 years prior to enrollment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Treatment with investigational therapy within 28 days prior to enrollment

Inclusion Criteria for the Maintenance Phase:

  • ECOG PS of 0 or 1
  • Ongoing response or stable disease per RECIST 1.1 after 4 cycles of induction therapy
  • Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade <=1
  • Adequate hematologic and end-organ function

Exclusion Criteria for the Maintenance Phase:

  • Presence or history of CNS metastases
  • Receiving consolidative chest radiation
  • Severe infection within 2 weeks prior to randomization into the maintenance
  • Treatment with therapeutic oral or IV antibiotics at the time of randomization

Sites / Locations

  • Alabama OncologyRecruiting
  • Va Palo Alto Health Care System
  • National Jewish HealthRecruiting
  • MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)Recruiting
  • Florida Cancer Specialists - Fort Myers (Broadway)Recruiting
  • Florida Cancer Specialist, North RegionRecruiting
  • SCRI Florida Cancer Specialists PANRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
  • Illinois Cancer CareRecruiting
  • Hematology Oncology ClinicRecruiting
  • New England Cancer SpecialistsRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Cancer & Hematology Centers of Western Michigan; Spectrum Health Butterworth Research Pharmacy
  • Mercy Research - St. LouisRecruiting
  • Mercy Research SPRGRecruiting
  • Optum Health CareRecruiting
  • Clinical Research AllianceRecruiting
  • Messino Cancer CentersRecruiting
  • The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
  • Fox Chase Cancer Center
  • Rhode Island HospitalRecruiting
  • Hollings Cancer CenterRecruiting
  • Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street
  • West ClinicRecruiting
  • Tennessee Oncology; Sarah Cannon Research Institute
  • Michael E. DeBakey VA Medical CenterRecruiting
  • Mays Cancer Center at UT Health San Antonio MD Anderson CancerRecruiting
  • Cancer Care Northwest - Spokane ValleyRecruiting
  • Institut Jules BordetRecruiting
  • Jessa Zkh (Campus Virga Jesse)Recruiting
  • UZ Leuven GasthuisbergRecruiting
  • AZ St Maarten Campus LeopoldstrRecruiting
  • CHU UCL Mont-GodinneRecruiting
  • VitazRecruiting
  • Zentralklinik Bad Berka GmbH; Abteilung Onkologie und HämatologieRecruiting
  • Evang. Lungenklinik Berlin Klinik für PneumologieRecruiting
  • Helios Klinikum Emil von Behring GmbHRecruiting
  • Klinikum Chemnitz gGmbHRecruiting
  • Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbHRecruiting
  • Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbHRecruiting
  • LungenClinic Großhansdorf GmbH
  • Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin IIRecruiting
  • KRH Klinikum Siloah-Oststadt-Heidehaus
  • Fachklinik für Lungenerkrankungen
  • Universitätsklinikum Schleswig-Holstein; Campus Lübeck
  • Asklepios Klinik München-GautingRecruiting
  • Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / HämatologieRecruiting
  • Sotiria Thoracic Diseases Hospital of Athens; 3rd University Pathology ClinicRecruiting
  • ERRIKOS DYNAN HOSPITAL; 4th ONCOLOGY CLINICRecruiting
  • University Hospital of Larissa;Department of Medical OncologyRecruiting
  • Euromedical General Clinic of Thessaloniki; Oncology Department
  • Diavalkaniko HospitalRecruiting
  • Orszagos Koranyi Pulmonologiai IntezetRecruiting
  • Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás IntézetRecruiting
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.Recruiting
  • Tudogyogyintezet Torokbalint
  • AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
  • ASL 3 Genovese
  • Irccs Ospedale San Raffaele;Oncologia MedicaRecruiting
  • Irccs Istituto Europeo di Oncologia (IEO); Divisione di OncologiaRecruiting
  • Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.FalckRecruiting
  • Azienda Ospedaliero Universitaria Ospedali RiunitiRecruiting
  • Chungbuk National University HospitalRecruiting
  • Chilgok Kyungpook National University Medical CenterRecruiting
  • Samsung Changwon HospitalRecruiting
  • Gyeongsang National University HospitalRecruiting
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Samsung Medical CenterRecruiting
  • Ulsan University HosiptalRecruiting
  • Antiguo Hospital Civil de Guadalajara Fray Antonio AlcaldeRecruiting
  • Health Pharma Professional Research
  • Filios Alta MedicinaRecruiting
  • Centro de Investigacion Clinica de Oaxaca
  • Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i RadioterapiiRecruiting
  • Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddzia? OnkologicznyRecruiting
  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Oddzial III Chorob PlucRecruiting
  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu; Oddzial Onkologii Klinicznej
  • Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie; Klinika Nowotworow Pluca i Klatki Piersiowej
  • Hospital Univ Vall d'Hebron; Servicio de OncologiaRecruiting
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
  • Hospital del Mar; Servicio de Oncologia
  • Hospital de la Santa Creu i Sant Pau; Servicio de OncologiaRecruiting
  • Hospital Universitario 12 de Octubre; Servicio de OncologiaRecruiting
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de OncologiaRecruiting
  • Hospital Universitario Virgen del Rocio; Servicio de OncologiaRecruiting
  • E-DA Hospital; ChestRecruiting
  • Taichung Veterans General Hospital; Dept of Internal Medicine
  • National Cheng Kung University Hospital; Oncology
  • Taipei Veterans General Hospital; Chest Dept , Section of Thoracic OncologyRecruiting
  • Adana Baskent University Hospital; Medical Oncology
  • Gülhane E?itim Ve Ara?t?rma HastanesiRecruiting
  • Memorial Ankara Hastanesi
  • Liv Hospital Ankara; Medical Oncology
  • Ankara City Hospital; Oncology
  • Uludag Uni Hospital; Oncology
  • Pamukkale University School Of Medicine; Oncology Department
  • Dicle University Faculty of Medicine
  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
  • Ba?c?lar Medipol Mega Üniversite Hastanesi; Oncology
  • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
  • ?zmir Medical Park; Onkoloji
  • Kocaeli University Faculty of Medicine; Medical oncology
  • Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
  • TC Necmettin Erbakan University Meram Medical Faculty Hospital
  • Medikal Park Samsun
  • Ac?badem Altunizade Hastanesi; Oncology
  • Ysbyty Gwynedd HospitalRecruiting
  • Blackpool Victoria Hospital
  • Western General Hospital; Edinburgh Cancer CenterRecruiting
  • Christie NHS Foundation Trust
  • Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
  • St James University HospitalRecruiting
  • Leicester Royal Infirmary
  • University College London HospitalRecruiting
  • Guy's Hospital; Oncology & Haematology Clinical Trials (OHCT) Unit. GI/Urology Research Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Atezolizumab+Lurbinectedin

Arm B: Atezolizumab

Arm Description

Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle.

Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle.

Outcomes

Primary Outcome Measures

IRF-Assessed Progression-Free Survival (PFS)
IRF-assessed progression-free survival (PFS) is defined as the time from randomization to the first occurrence of disease progression as determined by the IRF according to RECIST v1.1, or death from any cause (whichever occurs first).
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause.

Secondary Outcome Measures

Investigator-Assessed PFS
Investigator-assessed PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).
Confirmed Objective Response Rate (ORR)
Confirmed objective response rate (ORR) is defined as the proportion of randomized participants with a CR or PR on two consecutive occasions >= 4 weeks apart after randomization, as determined by the IRF and the investigator according to RECIST v1.1.
Duration of Response (DOR)
Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response after randomization until disease progression as determined by the IRF and the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).
PFS Rates
PFS rates at 6 months and 12 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months and 12 months after randomization, as determined by the IRF and the investigator according to RECIST v1.1.
OS Rates
OS rates at 12 months and 24 months is defined as the proportion of participants who have not experienced death from any cause at 12 months and 24 months after randomization.
Percentage of Participants With Adverse Events
Percentage of participants with adverse events.
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Percentage of participants with ADAs to atezolizumab after drug administration.
Time to Confirmed Deterioration (TTCD)
Time to confirmed deterioration (TTCD) from maintenance baseline in participant-reported physical functioning and global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30).

Full Information

First Posted
October 12, 2021
Last Updated
October 13, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Jazz Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT05091567
Brief Title
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
Acronym
IMforte
Official Title
A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy With Carboplatin, Etoposide and Atezolizumab
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
April 18, 2025 (Anticipated)
Study Completion Date
March 6, 2026 (Anticipated)

3. Sponsor/Collaborators

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

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
Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm A: Atezolizumab+Lurbinectedin
Arm Type
Experimental
Arm Description
Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle.
Arm Title
Arm B: Atezolizumab
Arm Type
Active Comparator
Arm Description
Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq, RO5541267
Intervention Description
Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.
Intervention Type
Drug
Intervention Name(s)
Lurbinectedin
Other Intervention Name(s)
PM01183/JZP712
Intervention Description
Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Primary Outcome Measure Information:
Title
IRF-Assessed Progression-Free Survival (PFS)
Description
IRF-assessed progression-free survival (PFS) is defined as the time from randomization to the first occurrence of disease progression as determined by the IRF according to RECIST v1.1, or death from any cause (whichever occurs first).
Time Frame
Randomization to the first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 52 months)
Title
Overall Survival (OS)
Description
Overall survival (OS) is defined as the time from randomization to death from any cause.
Time Frame
Randomization to death from any cause (up to approximately 52 months)
Secondary Outcome Measure Information:
Title
Investigator-Assessed PFS
Description
Investigator-assessed PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).
Time Frame
Randomization to the first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 52 months)
Title
Confirmed Objective Response Rate (ORR)
Description
Confirmed objective response rate (ORR) is defined as the proportion of randomized participants with a CR or PR on two consecutive occasions >= 4 weeks apart after randomization, as determined by the IRF and the investigator according to RECIST v1.1.
Time Frame
Up to approximately 52 months
Title
Duration of Response (DOR)
Description
Duration of Response (DOR) (for participants with a confirmed objective response) is defined as the time from the first occurrence of a documented confirmed objective response after randomization until disease progression as determined by the IRF and the investigator according to RECIST v1.1, or death from any cause (whichever occurs first).
Time Frame
Up to approximately 52 months
Title
PFS Rates
Description
PFS rates at 6 months and 12 months is defined as the proportion of participants who have not experienced disease progression or death from any cause at 6 months and 12 months after randomization, as determined by the IRF and the investigator according to RECIST v1.1.
Time Frame
6 months and 12 months after randomization
Title
OS Rates
Description
OS rates at 12 months and 24 months is defined as the proportion of participants who have not experienced death from any cause at 12 months and 24 months after randomization.
Time Frame
12 months and 24 months after randomization
Title
Percentage of Participants With Adverse Events
Description
Percentage of participants with adverse events.
Time Frame
Up to approximately 52 months
Title
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Description
Percentage of participants with ADAs to atezolizumab after drug administration.
Time Frame
Up to approximately 52 months
Title
Time to Confirmed Deterioration (TTCD)
Description
Time to confirmed deterioration (TTCD) from maintenance baseline in participant-reported physical functioning and global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30).
Time Frame
Maintenance phase baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for the Induction Phase: ECOG PS of 0 or 1 No prior systemic therapy for ES-SCLC Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC Histologically or cytologically confirmed ES-SCLC Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab Measurable disease, as defined by RECIST v1.1 Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening Exclusion Criteria for the Induction Phase: Presence or history of CNS metastases Active or history of autoimmune disease or deficiency History of malignancies other than SCLC within 5 years prior to enrollment Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan Treatment with investigational therapy within 28 days prior to enrollment Inclusion Criteria for the Maintenance Phase: ECOG PS of 0 or 1 Ongoing response or stable disease per RECIST 1.1 after 4 cycles of induction therapy Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade <=1 Adequate hematologic and end-organ function Exclusion Criteria for the Maintenance Phase: Presence or history of CNS metastases Receiving consolidative chest radiation Severe infection within 2 weeks prior to randomization into the maintenance Treatment with therapeutic oral or IV antibiotics at the time of randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: GO43104 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
Alabama Oncology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Name
Va Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Recruiting
Facility Name
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists - Fort Myers (Broadway)
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialist, North Region
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
SCRI Florida Cancer Specialists PAN
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Individual Site Status
Recruiting
Facility Name
Hematology Oncology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Name
New England Cancer Specialists
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer & Hematology Centers of Western Michigan; Spectrum Health Butterworth Research Pharmacy
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mercy Research - St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercy Research SPRG
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Individual Site Status
Recruiting
Facility Name
Optum Health Care
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Alliance
City
Westbury
State/Province
New York
ZIP/Postal Code
11590
Country
United States
Individual Site Status
Recruiting
Facility Name
Messino Cancer Centers
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Individual Site Status
Recruiting
Facility Name
The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Individual Site Status
Completed
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Name
Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
West Clinic
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Name
Tennessee Oncology; Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Mays Cancer Center at UT Health San Antonio MD Anderson Cancer
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Care Northwest - Spokane Valley
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Individual Site Status
Recruiting
Facility Name
Institut Jules Bordet
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Jessa Zkh (Campus Virga Jesse)
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ St Maarten Campus Leopoldstr
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU UCL Mont-Godinne
City
Mont-godinne
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Vitaz
City
Sint Niklaas
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Zentralklinik Bad Berka GmbH; Abteilung Onkologie und Hämatologie
City
Bad Berka
ZIP/Postal Code
99437
Country
Germany
Individual Site Status
Recruiting
Facility Name
Evang. Lungenklinik Berlin Klinik für Pneumologie
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Recruiting
Facility Name
Helios Klinikum Emil von Behring GmbH
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Name
Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH
City
Essen
ZIP/Postal Code
45136
Country
Germany
Individual Site Status
Recruiting
Facility Name
Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH
City
Georgsmarienhütte
ZIP/Postal Code
49124
Country
Germany
Individual Site Status
Recruiting
Facility Name
LungenClinic Großhansdorf GmbH
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
City
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
KRH Klinikum Siloah-Oststadt-Heidehaus
City
Hannover
ZIP/Postal Code
30459
Country
Germany
Individual Site Status
Completed
Facility Name
Fachklinik für Lungenerkrankungen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Schleswig-Holstein; Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Asklepios Klinik München-Gauting
City
München-Gauting
ZIP/Postal Code
82131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Individual Site Status
Recruiting
Facility Name
Sotiria Thoracic Diseases Hospital of Athens; 3rd University Pathology Clinic
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Name
ERRIKOS DYNAN HOSPITAL; 4th ONCOLOGY CLINIC
City
Athens
ZIP/Postal Code
11526
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of Larissa;Department of Medical Oncology
City
Larissa
ZIP/Postal Code
411 10
Country
Greece
Individual Site Status
Recruiting
Facility Name
Euromedical General Clinic of Thessaloniki; Oncology Department
City
Thessaloniki
ZIP/Postal Code
546 45
Country
Greece
Individual Site Status
Active, not recruiting
Facility Name
Diavalkaniko Hospital
City
Thessaloniki
ZIP/Postal Code
570 01
Country
Greece
Individual Site Status
Recruiting
Facility Name
Orszagos Koranyi Pulmonologiai Intezet
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Tudogyogyintezet Torokbalint
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Individual Site Status
Active, not recruiting
Facility Name
AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
ASL 3 Genovese
City
Genova
State/Province
Liguria
ZIP/Postal Code
16125
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Irccs Ospedale San Raffaele;Oncologia Medica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
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
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
City
Torrette Di Ancona
State/Province
Marche
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chilgok Kyungpook National University Medical Center
City
Daegu
ZIP/Postal Code
702-210
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Changwon Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
51353
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gyeongsang National University Hospital
City
Gyeongsangnam-do
ZIP/Postal Code
52727
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ulsan University Hosiptal
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
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
Active, not recruiting
Facility Name
Filios Alta Medicina
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion Clinica de Oaxaca
City
Oaxaca de Juárez
State/Province
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii
City
Gda?sk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddzia? Onkologiczny
City
Kraków
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
Active, not recruiting
Facility Name
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy; Oddzial III Chorob Pluc
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu; Oddzial Onkologii Klinicznej
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie; Klinika Nowotworow Pluca i Klatki Piersiowej
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Hospital Univ Vall d'Hebron; Servicio de Oncologia
City
Sant Andreu de La Barca
State/Province
Barcelona
ZIP/Postal Code
08740
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
City
A Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital del Mar; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08041
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
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
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
E-DA Hospital; Chest
City
Kaohsiung
ZIP/Postal Code
824
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taichung Veterans General Hospital; Dept of Internal Medicine
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
National Cheng Kung University Hospital; Oncology
City
Tainan
ZIP/Postal Code
00704
Country
Taiwan
Individual Site Status
Active, not 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
Adana Baskent University Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Gülhane E?itim Ve Ara?t?rma Hastanesi
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Memorial Ankara Hastanesi
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Liv Hospital Ankara; Medical Oncology
City
Ankara
ZIP/Postal Code
06680
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ankara City Hospital; Oncology
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Uludag Uni Hospital; Oncology
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Pamukkale University School Of Medicine; Oncology Department
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Individual Site Status
Completed
Facility Name
Dicle University Faculty of Medicine
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ba?c?lar Medipol Mega Üniversite Hastanesi; Oncology
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
City
Istanbul
ZIP/Postal Code
34300
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
?zmir Medical Park; Onkoloji
City
Izmir
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Kocaeli University Faculty of Medicine; Medical oncology
City
Izmit
ZIP/Postal Code
31380
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology
City
Kadiköy
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
TC Necmettin Erbakan University Meram Medical Faculty Hospital
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Medikal Park Samsun
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ac?badem Altunizade Hastanesi; Oncology
City
Üsküdar
ZIP/Postal Code
34662
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Ysbyty Gwynedd Hospital
City
Bangor
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Western General Hospital; Edinburgh Cancer Center
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Christie NHS Foundation Trust
City
GB Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Castle Hill Hospital; The Queen's Centre for Oncology & Haematology
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
N7 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guy's Hospital; Oncology & Haematology Clinical Trials (OHCT) Unit. GI/Urology Research Office
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer

We'll reach out to this number within 24 hrs