A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)
B-FAST
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)
2 other identifiers
interventional
1,000
27 countries
164
Brief Summary
This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by a blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assay.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Sep 2017
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedStudy Start
First participant enrolled
September 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
March 9, 2026
March 1, 2026
9.1 years
June 5, 2017
March 6, 2026
Conditions
Outcome Measures
Primary Outcomes (7)
Cohort A: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Baseline up to disease progression or death (up to approximately 6 years)
Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1
Baseline up to disease progression or death (up to approximately 6 years)
Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on RECIST v1.1 in bTMB PP1
Baseline up to disease progression or death (up to approximately 6 years)
Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1
Baseline up to disease progression or death (up to approximately 6 years)
Cohort E: Time in Response (TIR) as Assessed by the Investigator Based on RECIST v1.1
Month 12
Cohort F: Investigator-Assessed Objective Response Rate (ORR) Based on RECIST v1.1
Baseline up to disease progression or death (up to approximately 6 years)
Cohort G: Incidence of Adverse Events (AEs)
Baseline to last dose of study treatment + 30 days or until initiation of new anticancer therapy, whichever occurs first (up to approximately 6 years)
Secondary Outcomes (41)
Cohorts A-F: Duration of Response (DOR) as Assessed by the Investigator Based on RECIST v1.1
Baseline up to disease progression or death (up to approximately 6 years)
Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by the Investigator Based on RECIST v1.1
Baseline up to disease progression or death (up to approximately 6 years)
Cohorts A, B, D, F: PFS as Assessed by the Investigator Based on RECIST v1.1
Baseline up to disease progression or death (up to approximately 6 years)
Cohorts A-F: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on RECIST v1.1
Baseline up to disease progression or death (up to approximately 6 years)
Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by IRF Based on RECIST v1.1
Baseline up to disease progression or death (up to approximately 6 years)
- +36 more secondary outcomes
Study Arms (11)
Cohort A: Alectinib 600 Milligrams (mg)
EXPERIMENTALThis 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.
Cohort B: Dose Finding Phase (DFP) Alectinib
EXPERIMENTALThis 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.
Cohort B: Dose Expansion Phase (DEP) Alectinib
EXPERIMENTALThis 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.
Cohort C: Atezolizumab 1200 mg
EXPERIMENTALThis 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.
Cohort C: Pemetrexed, Cisplatin or Carboplatin
ACTIVE COMPARATORThis 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.
Cohort C: Gemcitabine, Cisplatin or Carboplatin
ACTIVE COMPARATORThis 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.
Cohort D: Entrectinib 600 Milligrams (mg)
EXPERIMENTALThis 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.
Cohort E: Atezolizumab, Vemurafenib, and Cobimetinib
EXPERIMENTALThis 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.
Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and Pemetrexed
EXPERIMENTALThis 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.
Cohort G: Divarasib or Docetaxel
EXPERIMENTALExperimental: 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.
Cohort Z: Natural History Cohort
NO INTERVENTIONParticipants with genomic profiles of interest that are not enrolled in the other cohorts will enter into natural history follow-up.
Interventions
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.
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).
Participants will receive pemetrexed 500 mg/m\^2 IV infusion on Day 1 Q21D.
Participants will receive cisplatin 75 mg/m\^2 IV on Day 1 Q21D.
Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.
Participants will receive gemcitabine 1000 or 1250 mg/m\^2 on Days 1 and 8 of every cycle (1 Cycle=21 days).
Participants will receive entrectinib 600 mg orally QD.
Participants will receive 60 mg PO QD on Days 1-21 of the initial run-in and triple-combination periods.
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.
Participants will receive 15 mg/kg of IV bevacizumab on Day 1 of each 21-day cycle during the induction and maintenance periods.
Participants will receive divarasib PO QD until disease progression or unacceptable toxicity.
Participants will receive IV docetaxel Q3W (75 mg/m\^2) until disease progression or unacceptable toxicity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (164)
UC Davis
Sacramento, California, 95817, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, 33901, United States
Florida Cancer Specialist, North Region
St. Petersburg, Florida, 33705, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, 10021, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Oregon HSU
Portland, Oregon, 97210, United States
St. Luke's University Health network
Bethlehem, Pennsylvania, 18015, United States
Sarah Cannon Research Institute / Tennessee Oncology
Chattanooga, Tennessee, 37404, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, C1125ABD, Argentina
Hospital Italiano
Buenos Aires, C1181ACH, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, C1284AEB, Argentina
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, 5037, Australia
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000, Brazil
Instituto Nacional de Cancer - INCa
Rio de Janeiro, 20560-120, Brazil
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
William Osler Health System Brampton Civic Hospital
Brampton, Ontario, L6R 3J7, Canada
London Health Sciences Centre · Victoria Hospital
London, Ontario, N6A 5W9, Canada
Lakeridge Health Center
Oshawa, Ontario, L1G 2B9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Center
Toronto, Ontario, M5G 1Z5, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
IUCPQ (Hôpital Laval)
Québec, Quebec, G1V 4G5, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, SK S7N 4H4, Canada
Bradford Hill Centro de Investigaciones Clinicas
Recoleta, 8420383, Chile
Beijing Cancer Hospital
Beijing, 100142, China
Jilin Cancer Hospital
Changchun, 132013, China
Hunan Cancer Hospital
Changsha, 410013, China
The second Xiangya hospital of central south university
Changsha, 410100, China
Sichuan Cancer Hospital
Chengdu, 610041, China
West China Hospital - Sichuan University
Chengdu, 610047, China
The First Affiliated Hospital of Guangzhou Medical University Pharmacy
Guangzhou, 510120, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Shandong Cancer Hospital
Jinan, 250117, China
The Second Affiliated Hospital to Nanchang University
Nanchang, 330006, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, 210008, China
Fudan Unviversity Shanghai Cancer Center
Shanghai, 200032, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061, China
Institut Bergonie CLCC Bordeaux
Bordeaux, 33000, France
Centre Francois Baclesse
Caen, 14076, France
Centre Oscar Lambret
Lille, 59020, France
Centre Léon Bérard
Lyon, 69373, France
Hopital Caremeau
Nîmes, 30029, France
Hopital Robert Schuman
Nouilly, 57645, France
Hôpital Européen Georges Pompidou
Paris, 75908, France
Hopital Tenon
Paris, 75970, France
CHU Poitiers
Poitiers, 86021, France
Hopital Pontchaillou
Rennes, 35033, France
CHU de Toulouse - Hôpital Larrey
Toulouse, 31059, France
Klinikum Chemnitz gGmbH
Chemnitz, 09116, Germany
Asklepios-Fachklinik Muenchen-Gauting
Gauting, 82131, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, 69126, Germany
HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed
Wiesbaden, 65199, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hosp
Shatin, Hong Kong
Soroka Medical Center
Beersheba, 8410101, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin MC
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center
Ramat Gan, 5262100, Israel
Sourasky / Ichilov Hospital; Dept. of Oncology
Tel Aviv, 6423906, Israel
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Naples, Campania, 80131, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, 47014, Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli Venezia Giulia, 33081, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, 00151, Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy, 24128, Italy
ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona
Cremona, Lombardy, 26100, Italy
Irccs Istituto Europeo di Oncologia (IEO)
Milan, Lombardy, 20141, Italy
Asst Di Monza
Monza, Lombardy, 20900, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano (TO), Piedmont, 10043, Italy
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyō City, 113-8677, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Kanazawa University Hospital
Ishikawa, 920-8641, Japan
Kanagawa Cancer Center
Kanagawa, 241-8515, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Shikoku Cancer Center
Matsuyama, 791-0280, Japan
Tohoku University Hospital
Miyagi, 980-8574, Japan
Sendai Kousei Hospital
Miyagi, 981-0914, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Kindai University Hospital
Osaka, 589-8511, Japan
Saga University Hospital
Saga, 849-8501, Japan
Shizuoka Cancer Center
Shizuoka, 411-8777, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Kyorin University Hospital
Tokyo, 181-8611, Japan
Fujita Health University Hospital
Toyoake-shi, 470-1192, Japan
Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
National Hospital Organization Yamaguchi - Ube Medical Center
Yamaguchi, 775-0241, Japan
Hospital Angeles Tijuana
Tijuana, Estado de Baja California, 22010, Mexico
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), 03100, Mexico
AVIX Investigación Clínica S.C
Monterrey, Nuevo León, 64710, Mexico
Oncologico Potosino
San Luis Potosí City, San Luis Potosí, 78250, Mexico
Auckland City Hospital
Auckland, 1023, New Zealand
Hemato Oncología de Panamá Especializada
Panama City, 0801, Panama
Hospital Nacional Edgardo Rebagliati Martins
Lima, 11, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, 15038, Peru
Instituto Peruano de Oncología y Radioterapia
Lima, Peru
Clinica Ricardo Palma
San Isidro, Lima 27, Peru
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gda?sk, 80-214, Poland
Krakowski Szpital Specjalistyczny im sw.Jana Pawla II
Krakow, 31-202, Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, 10-357, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
Otwock, 05-400, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, 60-569, Poland
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, 143423, Russia
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow, Moscow Oblast, 105229, Russia
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint Petersburg, Sankt-Peterburg, 197758, Russia
Clinical Oncology Dispensary
Omsk, 644013, Russia
Clinical Center of Serbia
Belgrade, 11000, Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade, 11080, Serbia
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, 21204, Serbia
Clinical Center Nis
Niš, 18000, Serbia
National University Hospital
Singapore, 119228, Singapore
National Cancer Centre
Singapore, 169610, Singapore
National Cancer Center
Gyeonggi-do, 10408, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Yonsei University Health System/Severance Hospital
Seoul, 120-752, South Korea
Insititut Catala D'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna, 15706, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Hospital General Univ. de Alicante
Alicante, 03010, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clínic i Provincial
Barcelona, 08036, Spain
ICO Badalona - Hospital Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Centro Integral Oncologico Clara Campal
Madrid, 28050, Spain
Hospital Universitario Puerta de Hierro
Madrid, 28222, Spain
Hospital Quiron de Madrid
Madrid, 28223, Spain
Hospital Regional Universitario Carlos Haya
Málaga, 29010, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
National Taiwan Uni Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, 333, Taiwan
Faculty of Med. Siriraj Hosp.
Bangkok, 10700, Thailand
Prince of Songkla University
Hat Yai, 90110, Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, 01230, Turkey (Türkiye)
Akdeniz University Medical Faculty; Medical Oncology Department
Antalya, 07070, Turkey (Türkiye)
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, 22770, Turkey (Türkiye)
Medipol University Medical Faculty; Oncology Department
Istanbul, 34214, Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital; Medikal Onkoloji
Istanbul, 34890, Turkey (Türkiye)
Medikal Park Izmir Hospital
Kar??yaka, 35575, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sihhiye/Ankara, 06230, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 38898120DERIVEDWang 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.
PMID: 38190582DERIVEDPeters 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.
PMID: 35995953DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2017
First Posted
June 7, 2017
Study Start
September 22, 2017
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing