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

NCT ID: NCT03178552

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-22

Study Completion Date

2026-10-31

Brief Summary

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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 a blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assay.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A: Alectinib 600 Milligrams (mg)

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.

Group Type EXPERIMENTAL

Alectinib

Intervention Type DRUG

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.

Cohort B: Dose Finding Phase (DFP) Alectinib

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.

Group Type EXPERIMENTAL

Alectinib

Intervention Type DRUG

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.

Cohort B: Dose Expansion Phase (DEP) Alectinib

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.

Group Type EXPERIMENTAL

Alectinib

Intervention Type DRUG

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.

Cohort C: Atezolizumab 1200 mg

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.

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type DRUG

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).

Cohort C: Pemetrexed, Cisplatin or Carboplatin

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.

Group Type ACTIVE_COMPARATOR

Pemetrexed

Intervention Type DRUG

Participants will receive pemetrexed 500 mg/m\^2 IV infusion on Day 1 Q21D.

Cisplatin

Intervention Type DRUG

Participants will receive cisplatin 75 mg/m\^2 IV on Day 1 Q21D.

Carboplatin

Intervention Type DRUG

Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.

Cohort C: Gemcitabine, Cisplatin or Carboplatin

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.

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Participants will receive cisplatin 75 mg/m\^2 IV on Day 1 Q21D.

Carboplatin

Intervention Type DRUG

Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.

Gemcitabine

Intervention Type DRUG

Participants will receive gemcitabine 1000 or 1250 mg/m\^2 on Days 1 and 8 of every cycle (1 Cycle=21 days).

Cohort D: Entrectinib 600 Milligrams (mg)

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.

Group Type EXPERIMENTAL

Entrectinib

Intervention Type DRUG

Participants will receive entrectinib 600 mg orally QD.

Cohort E: Atezolizumab, Vemurafenib, and Cobimetinib

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.

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type DRUG

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).

Cobimetinib

Intervention Type DRUG

Participants will receive 60 mg PO QD on Days 1-21 of the initial run-in and triple-combination periods.

Vemurafenib

Intervention Type DRUG

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.

Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and Pemetrexed

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.

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type DRUG

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).

Pemetrexed

Intervention Type DRUG

Participants will receive pemetrexed 500 mg/m\^2 IV infusion on Day 1 Q21D.

Carboplatin

Intervention Type DRUG

Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.

Bevacizumab

Intervention Type DRUG

Participants will receive 15 mg/kg of IV bevacizumab on Day 1 of each 21-day cycle during the induction and maintenance periods.

Cohort G: Divarasib or Docetaxel

Experimental: Cohort G: GDC-6036 or Docetaxel 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

New participants will no longer receive docetaxel.

Group Type EXPERIMENTAL

Divarasib

Intervention Type DRUG

Participants will receive divarasib PO QD until disease progression or unacceptable toxicity.

Docetaxel

Intervention Type DRUG

Participants will receive IV docetaxel Q3W (75 mg/m\^2) until disease progression or unacceptable toxicity

Cohort Z: Natural History Cohort

Participants with genomic profiles of interest that are not enrolled in the other cohorts will enter into natural history follow-up.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Alectinib

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

Atezolizumab

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

Pemetrexed

Participants will receive pemetrexed 500 mg/m\^2 IV infusion on Day 1 Q21D.

Intervention Type DRUG

Cisplatin

Participants will receive cisplatin 75 mg/m\^2 IV on Day 1 Q21D.

Intervention Type DRUG

Carboplatin

Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.

Intervention Type DRUG

Gemcitabine

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

Entrectinib

Participants will receive entrectinib 600 mg orally QD.

Intervention Type DRUG

Cobimetinib

Participants will receive 60 mg PO QD on Days 1-21 of the initial run-in and triple-combination periods.

Intervention Type DRUG

Vemurafenib

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

Bevacizumab

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

Divarasib

Participants will receive divarasib PO QD until disease progression or unacceptable toxicity.

Intervention Type DRUG

Docetaxel

Participants will receive IV docetaxel Q3W (75 mg/m\^2) until disease progression or unacceptable toxicity

Intervention Type DRUG

Other Intervention Names

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RO5424802 RO5541267 RO7102122 RO5514041 RO5185426 RO4876646 RO7435846; GDC-6036

Eligibility Criteria

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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 active or uncontrolled human immunodeficiency virus (HIV) infection
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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UC Davis

Sacramento, California, United States

Site Status

Rocky Mountain Cancer Center

Denver, Colorado, United States

Site Status

SCRI Florida Cancer Specialists South

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialist, North Region

St. Petersburg, Florida, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Weill Cornell Medical College-New York Presbyterian Hospital

New York, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Oregon HSU

Portland, Oregon, United States

Site Status

St. Luke's University Health network

Bethlehem, Pennsylvania, United States

Site Status

Sarah Cannon Research Institute / Tennessee Oncology

Chattanooga, Tennessee, United States

Site Status

Fundación CENIT para la Investigación en Neurociencias

Buenos Aires, , Argentina

Site Status

Hospital Italiano

Buenos Aires, , Argentina

Site Status

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Site Status

The Prince Charles Hospital

Chermside, Queensland, Australia

Site Status

Ashford Cancer Center Research

Kurralta Park, South Australia, Australia

Site Status

UZ Brussel

Brussels, , Belgium

Site Status

Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

Site Status

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Site Status

Instituto Nacional de Cancer - INCa

Rio de Janeiro, , Brazil

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Site Status

William Osler Health System Brampton Civic Hospital

Brampton, Ontario, Canada

Site Status

London Health Sciences Centre · Victoria Hospital

London, Ontario, Canada

Site Status

Lakeridge Health Center

Oshawa, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

IUCPQ (Hôpital Laval)

Québec, Quebec, Canada

Site Status

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status

Bradford Hill Centro de Investigaciones Clinicas

Recoleta, , Chile

Site Status

Beijing Cancer Hospital

Beijing, , China

Site Status

Jilin Cancer Hospital

Changchun, , China

Site Status

Hunan Cancer Hospital

Changsha, , China

Site Status

The second Xiangya hospital of central south university

Changsha, , China

Site Status

Sichuan Cancer Hospital

Chengdu, , China

Site Status

West China Hospital - Sichuan University

Chengdu, , China

Site Status

The First Affiliated Hospital of Guangzhou Medical University Pharmacy

Guangzhou, , China

Site Status

Zhejiang Cancer Hospital

Hangzhou, , China

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Shandong Cancer Hospital

Jinan, , China

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The Second Affiliated Hospital to Nanchang University

Nanchang, , China

Site Status

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, , China

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Fudan Unviversity Shanghai Cancer Center

Shanghai, , China

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First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, , China

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Centre Oscar Lambret

Lille, , France

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Centre Léon Bérard

Lyon, , France

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Hôpital Européen Georges Pompidou

Paris, , France

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Hopital Tenon

Paris, , France

Site Status

CHU Poitiers

Poitiers, , France

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Hopital Pontchaillou

Rennes, , France

Site Status

CHU de Toulouse - Hôpital Larrey

Toulouse, , France

Site Status

Klinikum Chemnitz gGmbH

Chemnitz, , Germany

Site Status

Asklepios-Fachklinik Muenchen-Gauting

Gauting, , Germany

Site Status

Thoraxklinik Heidelberg gGmbH

Heidelberg, , Germany

Site Status

HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed

Wiesbaden, , Germany

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

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Prince of Wales Hosp

Shatin, , Hong Kong

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Soroka Medical Center

Beersheba, , Israel

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Rambam Health Care Campus

Haifa, , Israel

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Meir Medical Center

Kfar Saba, , Israel

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Rabin MC

Petah Tikva, , Israel

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Chaim Sheba Medical Center

Ramat Gan, , Israel

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Sourasky / Ichilov Hospital; Dept. of Oncology

Tel Aviv, , Israel

Site Status

Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

Napoli, Campania, Italy

Site Status

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

Meldola, Emilia-Romagna, Italy

Site Status

Irccs Centro Di Riferimento Oncologico (CRO)

Aviano, Friuli Venezia Giulia, Italy

Site Status

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, Italy

Site Status

Asst Papa Giovanni XXIII

Bergamo, Lombardy, Italy

Site Status

ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona

Cremona, Lombardy, Italy

Site Status

Irccs Istituto Europeo di Oncologia (IEO)

Milan, Lombardy, Italy

Site Status

Asst Di Monza

Monza, Lombardy, Italy

Site Status

Azienda Sanitaria Ospedaliera S Luigi Gonzaga

Orbassano (TO), Piedmont, Italy

Site Status

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

Bunkyō City, , Japan

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National Hospital Organization Kyushu Medical Center

Fukuoka, , Japan

Site Status

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Site Status

Kyushu University Hospital

Fukuoka, , Japan

Site Status

Hiroshima University Hospital

Hiroshima, , Japan

Site Status

Kanazawa University Hospital

Ishikawa, , Japan

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Kanagawa Cancer Center

Kanagawa, , Japan

Site Status

University Hospital Kyoto Prefectural University of Medicine

Kyoto, , Japan

Site Status

Shikoku Cancer Center

Matsuyama, , Japan

Site Status

Tohoku University Hospital

Miyagi, , Japan

Site Status

Sendai Kousei Hospital

Miyagi, , Japan

Site Status

Niigata University Medical & Dental Hospital

Niigata, , Japan

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Niigata Cancer Center Hospital

Niigata, , Japan

Site Status

Kindai University Hospital

Osaka, , Japan

Site Status

Saga University Hospital

Saga, , Japan

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Shizuoka Cancer Center

Shizuoka, , Japan

Site Status

Juntendo University Hospital

Tokyo, , Japan

Site Status

The Cancer Institute Hospital of JFCR

Tokyo, , Japan

Site Status

Kyorin University Hospital

Tokyo, , Japan

Site Status

Fujita Health University Hospital

Toyoake-shi, , Japan

Site Status

Wakayama Medical University Hospital

Wakayama, , Japan

Site Status

National Hospital Organization Yamaguchi - Ube Medical Center

Yamaguchi, , Japan

Site Status

Hospital Angeles Tijuana

Tijuana, Estado de Baja California, Mexico

Site Status

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District), Mexico

Site Status

AVIX Investigación Clínica S.C

Monterrey, Nuevo León, Mexico

Site Status

Oncologico Potosino

San Luis Potosí City, San Luis Potosí, Mexico

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Hemato Oncología de Panamá Especializada

Panama City, , Panama

Site Status

Hospital Nacional Edgardo Rebagliati Martins

Lima, , Peru

Site Status

Instituto Nacional de Enfermedades Neoplasicas

Lima, , Peru

Site Status

Instituto Peruano de Oncología y Radioterapia

Lima, , Peru

Site Status

Clinica Ricardo Palma

San Isidro, , Peru

Site Status

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gda?sk, , Poland

Site Status

Krakowski Szpital Specjalistyczny im sw.Jana Pawla II

Krakow, , Poland

Site Status

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

Olsztyn, , Poland

Site Status

Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy

Otwock, , Poland

Site Status

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

Poznan, , Poland

Site Status

Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie

Warsaw, , Poland

Site Status

Moscow City Oncology Hospital #62

Moscovskaya Oblast, Moscow Oblast, Russia

Site Status

Principal Military Clinical Hospital n.a. N.N. Burdenko

Moscow, Moscow Oblast, Russia

Site Status

S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Clinical Oncology Dispensary

Omsk, , Russia

Site Status

Clinical Center of Serbia

Belgrade, , Serbia

Site Status

University Hospital Medical Center Bezanijska kosa

Belgrade, , Serbia

Site Status

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, , Serbia

Site Status

Clinical Center Nis

Niš, , Serbia

Site Status

National University Hospital

Singapore, , Singapore

Site Status

National Cancer Centre

Singapore, , Singapore

Site Status

National Cancer Center

Gyeonggi-do, , South Korea

Site Status

Chonnam National University Hwasun Hospital

Jeollanam-do, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Yonsei University Health System/Severance Hospital

Seoul, , South Korea

Site Status

Insititut Catala D'Oncologia

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, LA Coruna, Spain

Site Status

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Site Status

Hospital General Univ. de Alicante

Alicante, , Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Clínic i Provincial

Barcelona, , Spain

Site Status

ICO Badalona - Hospital Germans Trias i Pujol

Barcelona, , Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status

Hospital Ramon y Cajal

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Centro Integral Oncologico Clara Campal

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Site Status

Hospital Quiron de Madrid

Madrid, , Spain

Site Status

Hospital Regional Universitario Carlos Haya

Málaga, , Spain

Site Status

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

National Taiwan Uni Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Chang Gung Medical Foundation - Linkou

Taoyuan District, , Taiwan

Site Status

Chulalongkorn Hospital

Bangkok, , Thailand

Site Status

Ramathibodi Hospital

Bangkok, , Thailand

Site Status

Faculty of Med. Siriraj Hosp.

Bangkok, , Thailand

Site Status

Prince of Songkla University

Hat Yai, , Thailand

Site Status

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

Adana, , Turkey (Türkiye)

Site Status

Akdeniz University Medical Faculty; Medical Oncology Department

Antalya, , Turkey (Türkiye)

Site Status

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

Edirne, , Turkey (Türkiye)

Site Status

Medipol University Medical Faculty; Oncology Department

Istanbul, , Turkey (Türkiye)

Site Status

Marmara University Pendik Training and Research Hospital; Medikal Onkoloji

Istanbul, , Turkey (Türkiye)

Site Status

Medikal Park Izmir Hospital

Kar??yaka, , Turkey (Türkiye)

Site Status

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sihhiye/Ankara, , Turkey (Türkiye)

Site Status

Countries

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United States Argentina Australia Belgium Brazil Canada Chile China France Germany Hong Kong Israel Italy Japan Mexico New Zealand Panama Peru Poland Russia Serbia Singapore South Korea Spain Taiwan Thailand Turkey (Türkiye)

References

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Peters S, Gadgeel SM, Mok T, Nadal E, Kilickap S, Swalduz A, Cadranel J, Sugawara S, Chiu CH, Yu CJ, Moskovitz M, Tanaka T, Nersesian R, Shagan SM, Maclennan M, Mathisen M, Bhagawati-Prasad V, Diarra C, Assaf ZJ, Archer V, Dziadziuszko R. Entrectinib in ROS1-positive advanced non-small cell lung cancer: the phase 2/3 BFAST trial. Nat Med. 2024 Jul;30(7):1923-1932. doi: 10.1038/s41591-024-03008-4. Epub 2024 Jun 19.

Reference Type DERIVED
PMID: 38898120 (View on PubMed)

Wang HY, Ho CC, Lin YT, Liao WY, Chen CY, Shih JY, Yu CJ. Comprehensive Genomic Analysis of Patients With Non-Small-Cell Lung Cancer Using Blood-Based Circulating Tumor DNA Assay: Findings From the BFAST Database of a Single Center in Taiwan. JCO Precis Oncol. 2024 Jan;8:e2300314. doi: 10.1200/PO.23.00314.

Reference Type DERIVED
PMID: 38190582 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35995953 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-000076-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BO29554

Identifier Type: -

Identifier Source: org_study_id

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