{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"SPOTLIGHT","nct_id":"NCT03504397","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=spotlight-nct03504397. 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":"Spotlight","arms":[{"description":"Participants received intravenous (IV) infusion (minimum 2-hour) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\\^2) on cycle1 day1(C1D1) followed by 600 mg/m\\^2 every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received upto 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4/more cycles. mFOLFOX6 was administered on Days 1, 15 \\& 29 of each cycle (5-FU:400mg/m\\^2 IV bolus over 5-15 minutes followed by 2400mg/m\\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400mg/m\\^2 IV infusion over 2 hours; oxaliplatin: 85mg/m\\^2 IV infusion over 2 hours) A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants continued to receive 5-FU \\& Folinic acid on Days 1, 15 \\& 29 of each cycle at the investigator discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.","label":"mFOLFOX6 + Zolbetuximab","type":"EXPERIMENTAL"},{"description":"Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\\^2 IV bolus over 5-15 minutes followed by 2400mg/m\\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.","label":"Placebo plus mFOLFOX6","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-03-31","type":"ESTIMATED"},"conditions":["Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer","Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer","Metastatic Gastric Adenocarcinoma or Cancer","Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma"],"enrollment":{"count":565,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"zolbetuximab","otherNames":["IMAB362"],"type":"DRUG"},{"name":"placebo","otherNames":[],"type":"DRUG"},{"name":"oxaliplatin","otherNames":[],"type":"DRUG"},{"name":"folinic acid","otherNames":[],"type":"DRUG"},{"name":"fluorouracil","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-20","lead_sponsor":"Astellas Pharma Global Development, Inc.","official_title":"A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2022-09-09","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival (PFS)","timeFrame":"From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 62 months and 18 days)"}],"references":[{"citation":"Yamaguchi K, Shoji H, Yasui H, Oki E, Sakai D, Hamaguchi T, Tsuji A, Oshima T, Tsuda M, Minashi K, Yang J, Guerrero A, Ueno Y, Matsangou M, Gourgioti G, Nakanishi Y, Furuki S, Kuwamoto K, Yamada S, Shitara K. Zolbetuximab plus chemotherapy in Japanese patients with claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma: a combined subgroup analysis of the phase 3 SPOTLIGHT and GLOW trials. Gastric Cancer. 2026 Jul;29(4):777-787. doi: 10.1007/s10120-026-01738-7. Epub 2026 May 7.","pmid":"42095986","type":"DERIVED"},{"citation":"Stratton SP, Pang L, Pugh J, Kouzova M, Baldwin D, McDonald J, Lawrence-Glaze R, Moran S, Guerrero A, Moran D. Analytical and Clinical Performance of the VENTANA CLDN18 (43-14A) RxDx Assay in Gastric and Gastroesophageal Junction Adenocarcinoma Tissue Samples in SPOTLIGHT and GLOW. Mod Pathol. 2025 Dec;38(12):100844. doi: 10.1016/j.modpat.2025.100844. Epub 2025 Jul 16.","pmid":"40680855","type":"DERIVED"},{"citation":"Shitara K, Shah MA, Lordick F, Bang YJ, Ilson D, Van Cutsem E, Enzinger P, Kim SS, Klempner SJ, Moran D, Park JW, Bhattacharya P, Ajani JA, Xu RH. Zolbetuximab plus chemotherapy for locally advanced unresectable or metastatic stomach or gastroesophageal junction cancers: a plain language summary. Future Oncol. 2024;20(26):1861-1877. doi: 10.1080/14796694.2024.2342107. Epub 2024 May 24.","pmid":"38861294","type":"DERIVED"},{"citation":"Shitara K, Lordick F, Bang YJ, Enzinger P, Ilson D, Shah MA, Van Cutsem E, Xu RH, Aprile G, Xu J, Chao J, Pazo-Cid R, Kang YK, Yang J, Moran D, Bhattacharya P, Arozullah A, Park JW, Oh M, Ajani JA. Zolbetuximab plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, untreated, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (SPOTLIGHT): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2023 May 20;401(10389):1655-1668. doi: 10.1016/S0140-6736(23)00620-7. Epub 2023 Apr 15.","pmid":"37068504","type":"DERIVED"}],"start_date":{"date":"2018-06-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.","url":"https://clinicaltrials.gov/study/NCT03504397"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/spotlight-nct03504397"}