NCT03178552Active, not recruitingPhase 2/3
A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)
A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 5 Jun 2017
- Start date
- 22 Sept 2017
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Lung cancer
- NCT number
- NCT03178552
- EU CT number
- 2023-507500-31-00
- EudraCT number
- 2017-000076-28
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 1000
- From 22 Sept 2017 to the primary completion date, 30 Jun 2027
- 153 sites in 27 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to swallow oral medication
- 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
- 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
Other illness
- History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
- Known active or uncontrolled human immunodeficiency virus (HIV) infection
Other
- Women who are pregnant or lactating
- Symptomatic, untreated CNS metastases
- Inability to comply with other requirements of the protocol
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (153)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación CENIT para la Investigación en Neurociencias Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Italiano Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Britanico de Buenos Aires Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Unknown status |
| The Prince Charles Hospital Coordinator of this site? Confirm its status | Chermside | Australia | Unknown status |
| Ashford Cancer Center Research Coordinator of this site? Confirm its status | Kurralta Park | Australia | Unknown status |
| Royal North Shore Hospital Coordinator of this site? Confirm its status | St Leonards | Australia | Unknown status |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda Coordinator of this site? Confirm its status | Ijuí | Brazil | Unknown status |
| Hospital Sao Lucas - PUCRS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto Nacional de Câncer - INCA Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Instituto do Cancer do Estado de Sao Paulo - ICESP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Royal Victoria Regional Health Centre Coordinator of this site? Confirm its status | Barrie | Canada | Unknown status |
| William Osler Health System - Brampton Civic Hospital Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| London Health Sciences Centre · Victoria Hospital Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Lakeridge Health Center Coordinator of this site? Confirm its status | Oshawa | Canada | Unknown status |
| IUCPQ (Hôpital Laval) Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Saskatoon Cancer Centre Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
| Princess Margaret Cancer Center Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| CancerCare Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| Bradford Hill Centro de Investigaciones Clinicas Coordinator of this site? Confirm its status | Recoleta | Chile | Unknown status |
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Guangzhou Medical University Pharmacy Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Shandong Cancer Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Second Affiliated Hospital to Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Fudan Unviversity Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Klinikum Esslingen GmbH Coordinator of this site? Confirm its status | Esslingen am Neckar | Germany | Completed |
| Asklepios Klinik Gauting GmbH Coordinator of this site? Confirm its status | Gauting | Germany | Completed |
| Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH Coordinator of this site? Confirm its status | Wiesbaden | Germany | Completed |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Active, not recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Completed |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Prince of Wales Hosp Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Unknown status |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Unknown status |
| Rabin MC Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| Chaim Sheba Medical Center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Sourasky / Ichilov Hospital; Dept. of Oncology Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Centro di Riferimento Oncologico di Aviano Coordinator of this site? Confirm its status | Aviano | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| Azienda Socio-Sanitaria Territoriale di Cremona Coordinator of this site? Confirm its status | Cremona | Italy | Active, not recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Active, not recruiting |
| European Institute Of Oncology S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Active, not recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Active, not recruiting |
| San Camillo Forlanini Hospital Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| National Hospital Organization Kyushu Medical Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| National Hospital Organization Kyushu Cancer Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Hiroshima University Hospital Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| Kanazawa University Hospital Coordinator of this site? Confirm its status | Ishikawa | Japan | Unknown status |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Shikoku Cancer Center Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Sendai Kousei Hospital Coordinator of this site? Confirm its status | Miyagi | Japan | Unknown status |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Miyagi | Japan | Unknown status |
| Niigata University Medical & Dental Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Kindai University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Shizuoka | Japan | Unknown status |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Kyorin University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Fujita Health University Hospital Coordinator of this site? Confirm its status | Toyoake-shi | Japan | Unknown status |
| Wakayama Medical University Hospital Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| National Hospital Organization Yamaguchi Ube Medical Center Coordinator of this site? Confirm its status | Yamaguchi | Japan | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Jeollanam-do | South Korea | Unknown status |
| Yonsei University Health System, Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Health Pharma Professional Research Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Avix Investigación Clínica, S.C. Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Oncologico Potosino Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Unknown status |
| Hospital Angeles Tijuana Coordinator of this site? Confirm its status | Tijuana | Mexico | Unknown status |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Hemato Oncología de Panamá Especializada Coordinator of this site? Confirm its status | Panama City | Panama | Unknown status |
| Hospital Nacional Edgardo Rebagliati Martins Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Instituto Peruano de Oncología y Radioterapia Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Instituto Nacional de Enfermedades Neoplasicas Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Clinica Ricardo Palma Coordinator of this site? Confirm its status | San Isidro | Peru | Unknown status |
| Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Active, not recruiting |
| Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy Coordinator of this site? Confirm its status | Otwock | Poland | Active, not recruiting |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Clinical Center of Serbia Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| University Hospital Medical Center Bezanijska Kosa Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Institute for Pulmonary Diseases of Vojvodina Coordinator of this site? Confirm its status | Kamenitz | Serbia | Unknown status |
| Clinical Center Nis Coordinator of this site? Confirm its status | Niš | Serbia | Unknown status |
| Moscow City Oncology Hospital #62 Coordinator of this site? Confirm its status | Moscovskaya Oblast | Russia | Unknown status |
| Principal Military Clinical Hospital n.a. N.N. Burdenko Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Clinical Oncology Dispensary Coordinator of this site? Confirm its status | Omsk | Russia | Unknown status |
| S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| National Cancer Centre Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Faculty of Med. Siriraj Hosp. Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Prince of Songkla University Coordinator of this site? Confirm its status | Hat Yai | Thailand | Unknown status |
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| National Taiwan Uni Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Medical Foundation - Linkou Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| St. Luke's University Health Network Coordinator of this site? Confirm its status | Bethlehem | United States | Unknown status |
| Sarah Cannon Research Institute / Tennessee Oncology Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Rocky Mountain Cancer Center Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| SCRI Florida Cancer Specialists South Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Comprehensive Cancer Centers of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Weill Cornell Medical College-New York Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Oregon HSU Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| UC Davis Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Florida Cancer Specialist, North Region Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Akdeniz University Medical Faculty; Medical Oncology Department Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
| Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| Marmara University Pendik Training and Research Hospital; Medikal Onkoloji Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Medipol University Medical Faculty; Oncology Department Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Medikal Park Izmir Hospital Coordinator of this site? Confirm its status | Kar??yaka | Turkey (Türkiye) | Unknown status |
| Hacettepe Uni Medical Faculty Hospital; Oncology Dept Coordinator of this site? Confirm its status | Sihhiye/Ankara | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.