{"preliminary_commentary":{"by_channel":{"x_thread":3,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"B-FAST","nct_id":"NCT03178552","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=b-fast-nct03178552. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"B-FAST","arms":[{"description":"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.\n\nEnrollment to Cohort A is complete.","label":"Cohort A: Alectinib 600 Milligrams (mg)","type":"EXPERIMENTAL"},{"description":"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.\n\nEnrollment to Cohort B is complete.","label":"Cohort B: Dose Finding Phase (DFP) Alectinib","type":"EXPERIMENTAL"},{"description":"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.\n\nEnrollment to Cohort B is complete.","label":"Cohort B: Dose Expansion Phase (DEP) Alectinib","type":"EXPERIMENTAL"},{"description":"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.\n\nEnrollment to Cohort C is complete.","label":"Cohort C: Atezolizumab 1200 mg","type":"EXPERIMENTAL"},{"description":"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.\n\nEnrollment to Cohort C is complete.","label":"Cohort C: Pemetrexed, Cisplatin or Carboplatin","type":"ACTIVE_COMPARATOR"},{"description":"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.\n\nEnrollment to Cohort C is complete.","label":"Cohort C: Gemcitabine, Cisplatin or Carboplatin","type":"ACTIVE_COMPARATOR"},{"description":"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.\n\nEnrollment to Cohort D is complete.","label":"Cohort D: Entrectinib 600 Milligrams (mg)","type":"EXPERIMENTAL"},{"description":"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.\n\nEnrollment to Cohort E is complete.","label":"Cohort E: Atezolizumab, Vemurafenib, and Cobimetinib","type":"EXPERIMENTAL"},{"description":"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.\n\nEnrollment to Cohort F is complete.","label":"Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and Pemetrexed","type":"EXPERIMENTAL"},{"description":"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\n\nNew participants will no longer receive docetaxel.","label":"Cohort G: Divarasib or Docetaxel","type":"EXPERIMENTAL"},{"description":"Participants with genomic profiles of interest that are not enrolled in the other cohorts will enter into natural history follow-up.","label":"Cohort Z: Natural History Cohort","type":"NO_INTERVENTION"}],"collaborators":[],"completion_date":{"date":"2027-06-30","type":"ESTIMATED"},"conditions":["Non-Small Cell Lung Cancer"],"enrollment":{"count":1000,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Alectinib","otherNames":["RO5424802"],"type":"DRUG"},{"name":"Atezolizumab","otherNames":["RO5541267"],"type":"DRUG"},{"name":"Pemetrexed","otherNames":[],"type":"DRUG"},{"name":"Cisplatin","otherNames":[],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"},{"name":"Gemcitabine","otherNames":[],"type":"DRUG"},{"name":"Entrectinib","otherNames":["RO7102122"],"type":"DRUG"},{"name":"Cobimetinib","otherNames":["RO5514041"],"type":"DRUG"},{"name":"Vemurafenib","otherNames":["RO5185426"],"type":"DRUG"},{"name":"Bevacizumab","otherNames":["RO4876646"],"type":"DRUG"},{"name":"Divarasib","otherNames":["RO7435846; GDC-6036"],"type":"DRUG"},{"name":"Docetaxel","otherNames":[],"type":"DRUG"}],"last_update":"2026-09-03","lead_sponsor":"Hoffmann-La Roche","official_title":"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)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2027-06-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"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","timeFrame":"Baseline up to disease progression or death (up to approximately 6 years)"},{"measure":"Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1","timeFrame":"Baseline up to disease progression or death (up to approximately 6 years)"},{"measure":"Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on RECIST v1.1 in bTMB PP1","timeFrame":"Baseline up to disease progression or death (up to approximately 6 years)"},{"measure":"Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1","timeFrame":"Baseline up to disease progression or death (up to approximately 6 years)"},{"measure":"Cohort E: Time in Response (TIR) as Assessed by the Investigator Based on RECIST v1.1","timeFrame":"Month 12"},{"measure":"Cohort F: Investigator-Assessed Objective Response Rate (ORR) Based on RECIST v1.1","timeFrame":"Baseline up to disease progression or death (up to approximately 6 years)"},{"measure":"Cohort G: Incidence of Adverse Events (AEs)","timeFrame":"Baseline to last dose of study treatment + 30 days or until initiation of new anticancer therapy, whichever occurs first (up to approximately 6 years)"}],"references":[{"citation":"Mayerhoefer ME, Kienzle A, Woo S, Vargas HA. Update on Liquid Biopsy. Radiology. 2025 Jun;315(3):e241030. doi: 10.1148/radiol.241030.","pmid":"40525978","type":"DERIVED"},{"citation":"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":"38898120","type":"DERIVED"},{"citation":"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.","pmid":"38190582","type":"DERIVED"},{"citation":"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.","pmid":"35995953","type":"DERIVED"}],"start_date":{"date":"2017-09-22","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)","url":"https://clinicaltrials.gov/study/NCT03178552"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/b-fast-nct03178552"}