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A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) (AcceleRET-Lung)

Primary Purpose

RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm, Carcinoma, Non-Small-Cell Lung

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pralsetinib
Carboplatin
Cisplatin
Pemetrexed
Pembrolizumab
Gemcitabine
Paclitaxel
Nab-Paclitaxel
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for RET-fusion Non Small Cell Lung Cancer focused on measuring Advanced Non-Small Cell Lung Cancer, RET Lung, RET Mutation, RET Alteration, RET Positive, RET Inhibitor, RET Altered, RET Rearrangement, RET NSCLC, RET-Rearranged NSCLC, RET Fusion, RET Fusion Lung Cancer, M918T, TRIM33-RET, Lung Cancer Mutation, BLU 667, Pralsetinib, RET Tyrosine Kinase, RET Gene Mutation, RET Kinase, Advanced Lung Cancer, Metastatic Lung Cancer, KIF5B-RET, CCDC6-RET

Eligibility Criteria

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

Inclusion criteria:

  • Participant has pathologically confirmed, definitively diagnosed, locally advanced (not able to be treated with surgery or radiotherapy) or metastatic NSCLC and has not been treated with systemic anticancer therapy for metastatic disease.
  • Participant must have a documented RET-fusion
  • Participant has measurable disease based on RECIST 1.1 as determined by the local site Investigator/radiology assessment.
  • Participant has an ECOG Performance Status of 0 or 1.

  • Participant should not have received any prior anticancer therapy for metastatic disease.

    • Participants can have received previous anticancer therapy (except a selective RET inhibitor) in the neoadjuvant or adjuvant setting but must have experienced an interval of at least ≥ 6 months from completion of therapy to recurrence.
    • Participants that received previous immune checkpoint inhibitors in the adjuvant or consolidation following chemoradiation are not allowed to receive pembrolizumab if randomized in Arm B
  • Participant is an appropriate candidate for and agrees to receive 1 of the Investigator choice platinum-based chemotherapy regimens if randomized to Arm B.
  • For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception.
  • For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom and agree to refrain from donating sperm.

Exclusion criteria:

  • Participant's tumor has any additional known primary driver alterations other than RET, such as targetable mutations of EGFR, ALK, ROS1, MET, and BRAF. Investigators should discuss enrollment with Sponsor designee regarding co-mutations.
  • Participant previously received treatment with a selective RET inhibitor.
  • Participant received radiotherapy or radiosurgery to any site within 14 days before randomization or more than 30 Gy of radiotherapy to the lung in the 6 months before randomization.
  • Participant with a history of pneumonitis within the last 12 months.
  • Participant has CNS metastases or a primary CNS tumor that is associated with progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease. If a participant requires corticosteroids for management of CNS disease, the dose must have been stable for the 2 weeks before Cycle 1 Day 1.
  • Participant has had a history of another primary malignancy that has been diagnosed or required therapy within the past 3 years prior to randomization.

Sites / Locations

  • UC Irvine Medical Center
  • Southern California Kaiser Permanente
  • Sylvester Comprehensive Cancer Center; University of Miami School of Medicine
  • University of Maryland Marlene and Stewart Greenebaum Cancer Center
  • University of Michigan Hospital
  • UPMC - Hillman Cancer Center
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • University of Texas Health Science Center
  • Millennium Research & Clinical DevelopmentRecruiting
  • Fundación CENIT para la Investigación en NeurocienciasRecruiting
  • Hospital Britanico; OncologiaRecruiting
  • Centro Oncologico Korben; OncologyRecruiting
  • Centro Oncologico Riojano Integral (CORI)Recruiting
  • Royal North Shore Hospital; Department of Medical OncologyRecruiting
  • Flinders Medical CentreRecruiting
  • Mogilev Regional Oncology Center
  • State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology
  • Vitebsk Regional Clinical Oncology Dispensary
  • Institut Jules Bordet; Pulmonary Oncology
  • UZ AntwerpenRecruiting
  • Liga Norte Riograndense Contra O CâncerRecruiting
  • Oncosite - Centro de Pesquisa Clinica Em Oncologia LtdaRecruiting
  • Hospital Sao Lucas - PUCRSRecruiting
  • Instituto do Cancer do Estado de Sao Paulo - ICESPRecruiting
  • Hospital A. C. Camargo; OncologiaRecruiting
  • Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)
  • Clinica CIMCARecruiting
  • Rigshospitalet, Onkologisk Klinik; Klinisk Forskningsenhed
  • Helsinki University Central Hospital; Dept of Oncology
  • Institut Bergonie CLCC BordeauxRecruiting
  • Hôpital Ambroise Paré - Boulogne-BillancourtRecruiting
  • Hôpital Louis Pradel, Hospices Civils de LyonRecruiting
  • CHRU Lille Service de Pneumologie et Oncologie ThoraciqueRecruiting
  • Institut Paoli Calmettes; Oncologie MedicaleRecruiting
  • Hopital Bichat Claude Bernard; Oncologie Serv.Recruiting
  • Institut Curie; Oncologie Medicale
  • Hopital Tenon;PneumologieRecruiting
  • Hopital de Pontchaillou; Service de PneumologieRecruiting
  • Ico Rene Gauducheau; OncologieRecruiting
  • CHU Strasbourg - Nouvel Hopital CivilRecruiting
  • CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologiqueRecruiting
  • Institut Gustave Roussy; Departement Oncologie MedicaleRecruiting
  • Universitätsklinikum Carl Gustav Carus, Medizinische Klinik I, Pneumologie MK1-A13
  • Klinikum Esslingen
  • Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
  • Thoraxklinik Heidelberg gGmbH
  • Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
  • Pius-Hospital; Klinik fuer Haematologie und Onkologie
  • Leopoldina-Krankenhaus Medizinische Klinik IIRecruiting
  • Klinik Schillerhöhe; Pneumologische OnkologieRecruiting
  • St. James Hospital; OncologyRecruiting
  • Shaare Zedek Medical Center; Oncology Dept
  • Meir Medical Center; Oncology
  • Sourasky / Ichilov Hospital; Dept. of Oncology
  • Ospedale Clinicizzato SS Annunziata
  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. PascaleRecruiting
  • Università degli Studi della Campania Luigi VanvitelliRecruiting
  • Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
  • Istituto Nazionale Tumori Regina Elena
  • AZ. Ospedaliera San Giovanni - Addolorata
  • Azienda Ospedaliera Sant'AndreaRecruiting
  • Irccs Ospedale San RaffaeleRecruiting
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto Europeo Di Oncologia
  • A.O.U. Maggiore della CaritàRecruiting
  • IRCCS Giovanni Paolo II Istituto Oncologico
  • Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco VascolareRecruiting
  • IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica IIRecruiting
  • A.O.U. INTEGRATA DI VERONA-Ospedale Civile Maggiore Borgo Trento; U.O.C. OncologiaRecruiting
  • Nagoya University HospitalRecruiting
  • Hirosaki University HospitalRecruiting
  • National Cancer Center Hospital EastRecruiting
  • Ehime University HospitalRecruiting
  • Kyushu University HospitalRecruiting
  • Kurume University HospitalRecruiting
  • National Hospital Organization Hokkaido Cancer CenterRecruiting
  • National Hospital Organization Himeji Medical Center
  • Iwate Medical University HospitalRecruiting
  • Kanagawa Cancer CenterRecruiting
  • Sendai Kousei HospitalRecruiting
  • Niigata Cancer Center HospitalRecruiting
  • Kurashiki Central HospitalRecruiting
  • Osaka City General HospitalRecruiting
  • Osaka International Cancer Institute
  • Kansai Medical University Hospital
  • Saitama Cancer CenterRecruiting
  • Juntendo University Hospital
  • The Cancer Institute Hospital of JFCR
  • National Hospital Organization Yamaguchi - Ube Medical Center
  • National Cancer CenterRecruiting
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical CenterRecruiting
  • COI Centro Oncologico Internacional SAPI de CV
  • Health Pharma Professional Research
  • Oncologico PotosinoRecruiting
  • NKI/AvL
  • Universitair Medisch Centrum GroningenRecruiting
  • Maastricht University Medical CenterRecruiting
  • Auckland City Hospital, Cancer and Blood ResearchRecruiting
  • Oslo universitetssykehus HF, Ullevål, KreftsenteretRecruiting
  • Hemato Oncología de Panamá Especializada
  • Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki PiersRecruiting
  • Hospital Garcia de Orta; Servico de PneumologiaRecruiting
  • Hospital de Braga; Serviço de PneumologiaRecruiting
  • IPO do Porto; Servico de Oncologia Medica
  • Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.ERecruiting
  • Hospital Univ. Central de Asturias; Servicio de OncologiaRecruiting
  • Hospital Universitario Germans Trias i PujolRecruiting
  • Insititut Catala D'OncologiaRecruiting
  • Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
  • Complejo Hospitalario Universitario A CoruñaRecruiting
  • Hospital Universitario Puerta de Hierro; Servicio de OncologiaRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Clínic. BarcelonaRecruiting
  • Hospital General Universitario Gregorio Marañon; Servicio de OncologiaRecruiting
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Universitario 12 de OctubreRecruiting
  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de OncologiaRecruiting
  • Hospital Regional Universitario de MalagaRecruiting
  • Hospital Universitario Virgen del Rocio; Servicio de OncologiaRecruiting
  • Hospital General Universitario de Valencia; Servicio de oncologiaRecruiting
  • Hosp Clinico Univ Lozano Blesa; División De Oncología MédicaRecruiting
  • Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01Recruiting
  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für OnkologieRecruiting
  • Adana City Hospital, Medical OncologyRecruiting
  • Adana Baskent University Hospital; Medical OncologyRecruiting
  • Ankara Bilkent City Hospital
  • Medipol Mega Üniversite Hastanesi GöztepeRecruiting
  • ?zmir Medical Point; OncologyRecruiting
  • Medical Park Seyhan Hospital; Oncology DepartmentRecruiting
  • CI of Kherson Regional Council Kherson Regional Oncology Dispensary
  • Ivano-Frankivsk Regional Oncology Center
  • MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
  • Velindre Cancer Centre; Oncology DeptRecruiting
  • Leicester Royal Infirmary; Dept. of Medical OncologyRecruiting
  • University College Hospital; Department of OncologyRecruiting
  • Guys & St Thomas Hospital; Department of OncologyRecruiting
  • Royal Marsden Hospital; Dept of Med-OncRecruiting
  • Christie Hospital Nhs Trust; Medical OncologyRecruiting
  • Royal Marsden Hospital; Dept of Medical OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pralsetinib

Platinum-based chemotherapy with or without pembrolizumab

Arm Description

Participants randomized to the Experimental Arm will receive Pralsetinib

Participants randomized to the Active Comparator Arm will receive 1 of 6 platinum-based chemotherapy treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating Investigator (based on histology) Nonsquamous histology Carboplatin or cisplatin / pemetrexed (with vitamin supplementation); with optional pemetrexed (with vitamin supplementation) maintenance. Pembrolizumab / carboplatin or cisplatin / pemetrexed (with vitamin supplementation); followed by pembrolizumab and optional pemetrexed (with vitamin supplementation) maintenance. Squamous histology Carboplatin or cisplatin / gemcitabine Carboplatin with paclitaxel/nab-paclitaxel and pembrolizumab

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
Defined as the time from randomisation date to the first documented progressive disease (PD), as assessed by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 central imaging review or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Overall Response Rate (ORR)
Defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as assessed by BICR according to RECIST 1.1 central imaging review.
Overall Survival (OS)
Defined as the time from randomisation date to death due to any cause.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
The intensity of Adverse Events (AEs) will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0).
Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Further characterising safety and tolerability.
Duration of Response (DOR)
Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as assessed by BICR according to RECIST v1.1.
Clinical Benefit Rate (CBR)
Defined as the proportion of participants who experience a best response of Stable Disease (SD) with a minimum duration of 6 months, a CR, or a PR, as assessed by BICR according to RECIST v1.1.
Disease Control Rate (DCR)
Defined as the proportion of participants who experience a best response of CR, or PR, or SD, as assessed by BICR according to RECIST v1.1.
European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ)-C30 Questionnaires
0-100 points (lower score represents worse quality of life)
European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ)-LC13 Scores
The item scale ranges from 1-4 (1 = Not at all; 4 = Very Much) where the EORTC-QLQ-LC13 scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability.

Full Information

First Posted
January 3, 2020
Last Updated
October 11, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04222972
Brief Title
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Acronym
AcceleRET-Lung
Official Title
A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2020 (Actual)
Primary Completion Date
November 28, 2024 (Anticipated)
Study Completion Date
June 25, 2026 (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 an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Participants who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Disease, Carcinoma, Bronchogenic, Bronchial Diseases, Head and Neck Neoplasms, Adenocarcinoma, Carcinoma, Neoplasms by Histologic Type, Neoplasms, Germ Cell and Embryonal, Neoplasms, Nerve Tissue
Keywords
Advanced Non-Small Cell Lung Cancer, RET Lung, RET Mutation, RET Alteration, RET Positive, RET Inhibitor, RET Altered, RET Rearrangement, RET NSCLC, RET-Rearranged NSCLC, RET Fusion, RET Fusion Lung Cancer, M918T, TRIM33-RET, Lung Cancer Mutation, BLU 667, Pralsetinib, RET Tyrosine Kinase, RET Gene Mutation, RET Kinase, Advanced Lung Cancer, Metastatic Lung Cancer, KIF5B-RET, CCDC6-RET

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Pralsetinib
Arm Type
Experimental
Arm Description
Participants randomized to the Experimental Arm will receive Pralsetinib
Arm Title
Platinum-based chemotherapy with or without pembrolizumab
Arm Type
Active Comparator
Arm Description
Participants randomized to the Active Comparator Arm will receive 1 of 6 platinum-based chemotherapy treatment regimens (with or without pembrolizumab) at the study center as chosen by the treating Investigator (based on histology) Nonsquamous histology Carboplatin or cisplatin / pemetrexed (with vitamin supplementation); with optional pemetrexed (with vitamin supplementation) maintenance. Pembrolizumab / carboplatin or cisplatin / pemetrexed (with vitamin supplementation); followed by pembrolizumab and optional pemetrexed (with vitamin supplementation) maintenance. Squamous histology Carboplatin or cisplatin / gemcitabine Carboplatin with paclitaxel/nab-paclitaxel and pembrolizumab
Intervention Type
Drug
Intervention Name(s)
Pralsetinib
Other Intervention Name(s)
BLU-667
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Nab-Paclitaxel
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Defined as the time from randomisation date to the first documented progressive disease (PD), as assessed by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 central imaging review or death due to any cause, whichever occurs first.
Time Frame
Estimated at up to 32 months
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as assessed by BICR according to RECIST 1.1 central imaging review.
Time Frame
Estimated at up to 32 months
Title
Overall Survival (OS)
Description
Defined as the time from randomisation date to death due to any cause.
Time Frame
Estimated at approximately 32 months
Title
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
The intensity of Adverse Events (AEs) will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0).
Time Frame
Baseline, at every 21 day cycle visit until progressive disease or death (estimated 32 months)
Title
Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Description
Further characterising safety and tolerability.
Time Frame
Baseline, at every 21 day cycle visit until progressive disease or death (estimated 32 months)
Title
Duration of Response (DOR)
Description
Defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as assessed by BICR according to RECIST v1.1.
Time Frame
Estimated at up to 32 months
Title
Clinical Benefit Rate (CBR)
Description
Defined as the proportion of participants who experience a best response of Stable Disease (SD) with a minimum duration of 6 months, a CR, or a PR, as assessed by BICR according to RECIST v1.1.
Time Frame
Estimated at up to 32 months
Title
Disease Control Rate (DCR)
Description
Defined as the proportion of participants who experience a best response of CR, or PR, or SD, as assessed by BICR according to RECIST v1.1.
Time Frame
Estimated at up to 32 months
Title
European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ)-C30 Questionnaires
Description
0-100 points (lower score represents worse quality of life)
Time Frame
From baseline until progressive disease or death (estimated 32 months)
Title
European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ)-LC13 Scores
Description
The item scale ranges from 1-4 (1 = Not at all; 4 = Very Much) where the EORTC-QLQ-LC13 scoring algorithm is applied to convert to a 0-100 point scale where 100 is best quality of life (QOL), for comparability.
Time Frame
From baseline until progressive disease or death (estimated 32 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participant has pathologically confirmed, definitively diagnosed, locally advanced (not able to be treated with surgery or radiotherapy) or metastatic NSCLC and has not been treated with systemic anticancer therapy for metastatic disease. Participant must have a documented RET-fusion Participant has measurable disease based on RECIST 1.1 as determined by the local site Investigator/radiology assessment. Participant has an ECOG Performance Status of 0 or 1. Participant should not have received any prior anticancer therapy for metastatic disease. Participants can have received previous anticancer therapy (except a selective RET inhibitor) in the neoadjuvant or adjuvant setting but must have experienced an interval of at least ≥ 6 months from completion of therapy to recurrence. Participants that received previous immune checkpoint inhibitors in the adjuvant or consolidation following chemoradiation are not allowed to receive pembrolizumab if randomized in Arm B Participant is an appropriate candidate for and agrees to receive 1 of the Investigator choice platinum-based chemotherapy regimens if randomized to Arm B. For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception. For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom and agree to refrain from donating sperm. Exclusion criteria: Participant's tumor has any additional known primary driver alterations other than RET, such as targetable mutations of EGFR, ALK, ROS1, MET, and BRAF. Investigators should discuss enrollment with Sponsor designee regarding co-mutations. Participant previously received treatment with a selective RET inhibitor. Participant received radiotherapy or radiosurgery to any site within 14 days before randomization or more than 30 Gy of radiotherapy to the lung in the 6 months before randomization. Participant with a history of pneumonitis within the last 12 months. Participant has CNS metastases or a primary CNS tumor that is associated with progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease. If a participant requires corticosteroids for management of CNS disease, the dose must have been stable for the 2 weeks before Cycle 1 Day 1. Participant has had a history of another primary malignancy that has been diagnosed or required therapy within the past 3 years prior to randomization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BO42864 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
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Completed
Facility Name
Southern California Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Individual Site Status
Completed
Facility Name
Sylvester Comprehensive Cancer Center; University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Maryland Marlene and Stewart Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Withdrawn
Facility Name
UPMC - Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Withdrawn
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Texas Health Science Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Withdrawn
Facility Name
Millennium Research & Clinical Development
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
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 Britanico; Oncologia
City
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Oncologico Korben; Oncology
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1426AGE
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
Recruiting
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Name
Mogilev Regional Oncology Center
City
Mogilev
State/Province
Mahilyowskaya Voblasts'
ZIP/Postal Code
212018
Country
Belarus
Individual Site Status
Withdrawn
Facility Name
State Inst N.N. Alexandrov Republican Scientific & Practical Centre of Oncology & Medical Radiology
City
A/g Lesnoy, Minsk Region
State/Province
Minsk
ZIP/Postal Code
223040
Country
Belarus
Individual Site Status
Withdrawn
Facility Name
Vitebsk Regional Clinical Oncology Dispensary
City
Vitebsk
State/Province
Vitsyebskaya Voblasts'
ZIP/Postal Code
BU-210603
Country
Belarus
Individual Site Status
Withdrawn
Facility Name
Institut Jules Bordet; Pulmonary Oncology
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Liga Norte Riograndense Contra O Câncer
City
Natal
State/Province
RN
ZIP/Postal Code
59040150
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
Hospital A. C. Camargo; Oncologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01509-010
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)
City
Ste. Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Clinica CIMCA
City
San José
ZIP/Postal Code
10103
Country
Costa Rica
Individual Site Status
Recruiting
Facility Name
Rigshospitalet, Onkologisk Klinik; Klinisk Forskningsenhed
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Withdrawn
Facility Name
Helsinki University Central Hospital; Dept of Oncology
City
Helsinki
ZIP/Postal Code
00250
Country
Finland
Individual Site Status
Withdrawn
Facility Name
Institut Bergonie CLCC Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Ambroise Paré - Boulogne-Billancourt
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Louis Pradel, Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Lille Service de Pneumologie et Oncologie Thoracique
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Paoli Calmettes; Oncologie Medicale
City
Marseille
ZIP/Postal Code
13273
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
Recruiting
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Individual Site Status
Withdrawn
Facility Name
Hopital Tenon;Pneumologie
City
Paris
ZIP/Postal Code
75970
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de Pontchaillou; Service de Pneumologie
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Name
Ico Rene Gauducheau; Oncologie
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Strasbourg - Nouvel Hopital Civil
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
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
Recruiting
Facility Name
Institut Gustave Roussy; Departement Oncologie Medicale
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik I, Pneumologie MK1-A13
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Klinikum Esslingen
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Thoraxklinik Heidelberg gGmbH
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Klinikum der Universität München; Campus Großhadern; Med. Klinik und Poliklinik V
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Pius-Hospital; Klinik fuer Haematologie und Onkologie
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Individual Site Status
Completed
Facility Name
Leopoldina-Krankenhaus Medizinische Klinik II
City
Schweinfurt
ZIP/Postal Code
97422
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinik Schillerhöhe; Pneumologische Onkologie
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Individual Site Status
Recruiting
Facility Name
St. James Hospital; Oncology
City
Dublin
ZIP/Postal Code
D08 HNY1
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Shaare Zedek Medical Center; Oncology Dept
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Meir Medical Center; Oncology
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Sourasky / Ichilov Hospital; Dept. of Oncology
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Ospedale Clinicizzato SS Annunziata
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Terminated
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
Università degli Studi della Campania Luigi Vanvitelli
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Provinciale Santa Maria Delle Croci; Oncologia Medica
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Istituto Nazionale Tumori Regina Elena
City
Roma
State/Province
Lazio
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
AZ. Ospedaliera San Giovanni - Addolorata
City
Roma
State/Province
Lazio
ZIP/Postal Code
00184
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Sant'Andrea
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Ospedale San Raffaele
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Istituto Europeo Di Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
A.O.U. Maggiore della Carità
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Giovanni Paolo II Istituto Oncologico
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Name
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.U. INTEGRATA DI VERONA-Ospedale Civile Maggiore Borgo Trento; U.O.C. Oncologia
City
Verona
State/Province
Veneto
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hirosaki University Hospital
City
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Ehime University Hospital
City
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Himeji Medical Center
City
Hyogo
ZIP/Postal Code
670-8520
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Iwate Medical University Hospital
City
Iwate
ZIP/Postal Code
028-3695
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Cancer Center
City
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sendai Kousei Hospital
City
Miyagi
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata Cancer Center Hospital
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kurashiki Central Hospital
City
Okayama
ZIP/Postal Code
710-8602
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka City General Hospital
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka International Cancer Institute
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kansai Medical University Hospital
City
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Saitama Cancer Center
City
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Hospital
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Active, not recruiting
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
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
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
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
Recruiting
Facility Name
COI Centro Oncologico Internacional SAPI de CV
City
Tijuana
State/Province
BAJA California SUR
ZIP/Postal Code
22010
Country
Mexico
Individual Site Status
Withdrawn
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
Oncologico Potosino
City
San Luis Potosí
State/Province
SAN LUIS Potosi
ZIP/Postal Code
78209
Country
Mexico
Individual Site Status
Recruiting
Facility Name
NKI/AvL
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Auckland City Hospital, Cancer and Blood Research
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
Oslo universitetssykehus HF, Ullevål, Kreftsenteret
City
Oslo
ZIP/Postal Code
0450
Country
Norway
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
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
Hospital Garcia de Orta; Servico de Pneumologia
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital de Braga; Serviço de Pneumologia
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
IPO do Porto; Servico de Oncologia Medica
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Univ. Central de Asturias; Servicio de Oncologia
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
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
Hospital Universitario Marques de Valdecilla; Servicio de Oncologia
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Complejo Hospitalario Universitario A Coruña
City
A Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
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 Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínic. Barcelona
City
Barcelona
ZIP/Postal Code
08036
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
Active, not recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga
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
Hospital General Universitario de Valencia; Servicio de oncologia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp Clinico Univ Lozano Blesa; División De Oncología Médica
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Individual Site Status
Recruiting
Facility Name
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Adana City Hospital, Medical Oncology
City
Adana
ZIP/Postal Code
01060
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Adana Baskent University Hospital; Medical Oncology
City
Adana
ZIP/Postal Code
01120
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Medipol Mega Üniversite Hastanesi Göztepe
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Recruiting
Facility Name
?zmir Medical Point; Oncology
City
Kar?iyaka
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medical Park Seyhan Hospital; Oncology Department
City
Seyhan
ZIP/Postal Code
01140
Country
Turkey
Individual Site Status
Recruiting
Facility Name
CI of Kherson Regional Council Kherson Regional Oncology Dispensary
City
Kherson
State/Province
Kherson Governorate
ZIP/Postal Code
73000
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Ivano-Frankivsk Regional Oncology Center
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology
City
Zaporizhzhya
ZIP/Postal Code
69040
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Velindre Cancer Centre; Oncology Dept
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Leicester Royal Infirmary; Dept. of Medical Oncology
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College Hospital; Department of Oncology
City
London
ZIP/Postal Code
N7 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guys & St Thomas Hospital; Department of Oncology
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Marsden Hospital; Dept of Med-Onc
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Christie Hospital Nhs Trust; Medical Oncology
City
Manchester
ZIP/Postal Code
M2O 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Marsden Hospital; Dept of Medical Oncology
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
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/ourmember/roche/). 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 Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

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