{"entity":{"id":"spotlight-glow","kind":"trial","name":"SPOTLIGHT & GLOW","aka":["SPOTLIGHT","GLOW","spotlight-glow"],"tldr":"Two trials that made Claudin 18.2 the third biomarker in stomach cancer, adding about two to three months of survival with an antibody against it.","summary":"SPOTLIGHT: PFS 10.6 vs 8.7 months, OS 18.2 vs 15.5 months. GLOW: PFS 8.2 vs 6.8, OS 14.4 vs 12.2 months. About 38% of screened patients were CLDN18.2-positive at the ≥75% threshold. FDA approval 18 October 2024 (Vyloy), first CLDN18.2-directed therapy. Nausea and vomiting, on-target from gastric mucosa, are frequent and front-loaded.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03504397","url":"https://clinicaltrials.gov/study/NCT03504397"},{"label":"GLOW NCT03653507","url":"https://clinicaltrials.gov/study/NCT03653507"}],"tags":[],"related":[],"cancers":["gastric","gastric-cldn18-2-positive"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["cldn18-2"],"drugs":["zolbetuximab","folfox","capox","oxaliplatin","capecitabine"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ryu-min-hee","shitara-kohei","rha-sun-young","kang-yoon-koo"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03504397","phase":"3","setting":"First-line CLDN18.2-positive (≥75% of cells), HER2-negative advanced gastric/GEJ adenocarcinoma: zolbetuximab + mFOLFOX6 (SPOTLIGHT) or CAPOX (GLOW) vs chemotherapy","sponsor":"Astellas","result":"SPOTLIGHT OS 18.2 vs 15.5 months; GLOW OS 14.4 vs 12.2 months.","started":"2018-06-21","startedType":"actual","yearReported":2023,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (SPOTLIGHT)","unit":"months","arms":[{"name":"Zolbetuximab + mFOLFOX6","value":18.2},{"name":"Placebo + mFOLFOX6","value":15.5}],"source":"https://www.gioncologynow.com/post/spotlight-glow-trials-lead-to-fda-approval-of-zolbetuximab-clzb-with-chemotherapy-for-gastric-gej-cancer"},{"endpoint":"Overall survival (GLOW)","unit":"months","arms":[{"name":"Zolbetuximab + CAPOX","value":14.4},{"name":"Placebo + CAPOX","value":12.2}],"source":"https://www.gioncologynow.com/post/spotlight-glow-trials-lead-to-fda-approval-of-zolbetuximab-clzb-with-chemotherapy-for-gastric-gej-cancer"}],"replication":"Two independent phase 3 trials with different chemotherapy backbones agree."},"route":"/trials/spotlight-glow/","neighbours":{"cancer":[{"id":"gastric-cldn18-2-positive","kind":"cancer","name":"Claudin 18.2-positive gastric cancer","route":"/cancers/gastric-cldn18-2-positive/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"cldn18-2","kind":"target","name":"Claudin 18.2","route":"/targets/cldn18-2/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"capox","kind":"drug","name":"CAPOX (capecitabine, oxaliplatin)","route":"/drugs/capox/"},{"id":"folfox","kind":"drug","name":"FOLFOX (5-FU, leucovorin, oxaliplatin)","route":"/drugs/folfox/"},{"id":"oxaliplatin","kind":"drug","name":"Oxaliplatin","route":"/drugs/oxaliplatin/"},{"id":"zolbetuximab","kind":"drug","name":"Zolbetuximab","route":"/drugs/zolbetuximab/"}],"company":[{"id":"astellas","kind":"company","name":"Astellas","route":"/companies/astellas/"}],"person":[{"id":"shitara-kohei","kind":"person","name":"Kohei Shitara","route":"/people/shitara-kohei/"},{"id":"ryu-min-hee","kind":"person","name":"Min-Hee Ryu","route":"/people/ryu-min-hee/"},{"id":"rha-sun-young","kind":"person","name":"Sun Young Rha","route":"/people/rha-sun-young/"},{"id":"kang-yoon-koo","kind":"person","name":"Yoon-Koo Kang","route":"/people/kang-yoon-koo/"}],"pairing":[{"id":"cldn18-antibody-then-adc","kind":"pairing","name":"CLDN18.2 antibody first line → CLDN18.2 ADC or CAR-T on progression","route":"/pairings/cldn18-antibody-then-adc/"}],"idea":[{"id":"idea-biomarker-quadruplet-gastric","kind":"idea","name":"Biomarker-directed first-line quadruplets in gastric cancer","route":"/ideas/idea-biomarker-quadruplet-gastric/"}]}}