{"commentary":{"count":19,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":7,"podcast":6,"x_thread":6},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05111626\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"FORTITUDE-102","nct_id":"NCT05111626","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=fortitude-102-nct05111626. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"FORTITUDE-102","arms":[{"description":"Participants will be administered bemarituzumab at different doses with mFOLFOX6 and nivolumab to determine the recommended phase 3 dose (RP3D) based on occurrence of dose-limiting toxicities (DLTs), and on an evaluation of the overall safety, tolerability, and pharmacokinetics (PK).","label":"Part 1 Safety Lead-in: Bemarituzumab with mFOLFOX6 and Nivolumab","type":"EXPERIMENTAL"},{"description":"Participants will be administered bemarituzumab at the RP3D determined from Part 1 in combination with mFOLFOX6 and nivolumab on a 14-day cycle.\n\nOr participants will be administered bemarituzumab in combination with CAPOX and nivolumab on a 21-day cycle.","label":"Part 2: Bemarituzumab with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab","type":"EXPERIMENTAL"},{"description":"Participants will be administered placebo comparator in combination with mFOLFOX6 and nivolumab on a 14-day cycle.\n\nOr participants will be administered placebo comparator in combination with CAPOX and nivolumab on a 21-day cycle.","label":"Part 2: Placebo with chemotherapy (mFOLFOX6 or CAPOX) and Nivolumab","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2025-10-29","type":"ACTUAL"},"conditions":["Gastric Cancer","Gastroesophageal Junction Adenocarcinoma"],"enrollment":{"count":515,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Bemarituzumab","type":"DRUG"},{"name":"Nivolumab","type":"DRUG"},{"name":"Chemotherapy","type":"DRUG"},{"name":"Placebo","type":"OTHER"}],"last_update":"2026-09-10","lead_sponsor":"Amgen","official_title":"A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression","overall_status":"TERMINATED","phases":["PHASE3"],"primary_completion_date":{"date":"2025-10-14","type":"ACTUAL"},"primary_outcomes":[{"measure":"Part 1: Number of Participants Who Experienced DLTs","timeFrame":"28 days"},{"measure":"Part 1: Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)","timeFrame":"Up to 4.5 years"},{"measure":"Part 1: Number of Participants Who Experienced One or More Related TEAEs","timeFrame":"Up to 4.5 years"},{"measure":"Part 1: Number of Participants With Clinically Significant Changes in Vital Signs","timeFrame":"Up to 4.5 years"},{"measure":"Part 1: Number of Participants With Clinically Significant Changes in Visual Acuity","timeFrame":"Up to 4.5 years"},{"measure":"Part 1: Number of Participants With Clinically Significant Changes in Physical Examinations","timeFrame":"Up to 4.5 years"},{"measure":"Part 1: Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests","timeFrame":"Up to 4.5 years"},{"measure":"Part 2: Overall Survival in FGFR2b ≥ 10% 2+/3+ Tumor Cell Staining Participants","timeFrame":"Up to 4.5 years"}],"references":[{"citation":"Maron SB, Xu RH, Wainberg ZA, Rha SY, Zhang Y, Pietrantonio F, Oliveira SCS, Li Y, Chen MH, Korphaisarn K, Elimova E, Calderon CA, Herpe FV, Yong WP, Dos Santos TM, Tan M, Isse K, Yanes RE, Shitara K. Global prevalence of FGFR2b protein overexpression in advanced gastric cancer and gastroesophageal junction cancers: pooled analysis of two bemarituzumab phase III studies. ESMO Open. 2026 Jun;11(6):107698. doi: 10.1016/j.esmoop.2026.107698. Epub 2026 May 26.","pmid":"42190313","type":"BACKGROUND"},{"citation":"Yu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036.","pmid":"40341124","type":"DERIVED"},{"citation":"Wainberg ZA, Kang YK, Lee KW, Qin S, Yamaguchi K, Kim IH, Saeed A, Oh SC, Li J, Turk HM, Teixeira A, Hitre E, Udrea AA, Cardellino GG, Sanchez RG, Zahlten-Kumeli A, Taylor K, Enzinger PC. Bemarituzumab as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: final analysis of the randomized phase 2 FIGHT trial. Gastric Cancer. 2024 May;27(3):558-570. doi: 10.1007/s10120-024-01466-w. Epub 2024 Feb 3.","pmid":"38308771","type":"DERIVED"}],"start_date":{"date":"2022-03-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.","url":"https://clinicaltrials.gov/study/NCT05111626"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/fortitude-102-nct05111626"}