{"entity":{"id":"gemstone-301","kind":"trial","name":"GEMSTONE-301","aka":[],"tldr":"Extended the PACIFIC idea to people who could not have chemotherapy and radiotherapy at the same time, the majority in much of the world.","summary":"PACIFIC established consolidation immunotherapy after concurrent chemoradiotherapy, but a substantial proportion of patients with stage III disease cannot tolerate or cannot access concurrent treatment and receive the two sequentially instead. GEMSTONE-301 tested whether consolidation still works in that population. It randomised 381 of 564 screened patients 2:1 at 50 Chinese centres between August 2018 and December 2020 to sugemalimab, an anti-PD-L1 antibody, or placebo, stratified by performance status, whether chemoradiotherapy was concurrent or sequential, and radiotherapy dose.\n\nAt the March 2021 cutoff, with a median follow-up of 14.3 months on sugemalimab and 13.7 on placebo, blinded independently reviewed progression-free survival was significantly longer with sugemalimab: median 9.0 months (95 percent confidence interval 8.1 to 14.1) against 5.8 months.\n\nThe trial matters because it is the only phase 3 evidence for consolidation after sequential chemoradiotherapy, and because sugemalimab is approved in China for this indication. It has no marketing authorisation for stage III disease in the United Kingdom, where NICE TA798 covers durvalumab after platinum-based chemoradiation instead.","status":"positive","asOf":"2026-09-25","links":[{"label":"ClinicalTrials.gov NCT03728556","url":"https://clinicaltrials.gov/study/NCT03728556"},{"label":"GEMSTONE-301 (Lancet Oncology 2022)","url":"https://doi.org/10.1016/S1470-2045(21)00630-6"}],"tags":[],"related":[],"cancers":["stage-iii-unresectable-nsclc"],"sections":[],"technologies":["checkpoint-inhibitor","imrt-igrt"],"targets":["pdl1"],"drugs":["sugemalimab"],"companies":["cstone"],"institutions":[],"pathways":[],"terms":["chemoradiation","consolidation-therapy"],"trials":["pacific","pacific-2"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03728556","phase":"3","setting":"Locally advanced unresectable stage III non-small-cell lung cancer in China without progression after either concurrent or sequential chemoradiotherapy: sugemalimab 1200 mg or placebo every three weeks for up to 24 months, with progression-free survival by blinded independent central review as the primary endpoint","sponsor":"CStone Pharmaceuticals","result":"Median progression-free survival 9.0 against 5.8 months by blinded independent review, including after sequential chemoradiotherapy.","yearReported":2022,"enrolled":381,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (blinded independent central review)","primary":true,"unit":"months","arms":[{"name":"Sugemalimab","n":255,"value":9},{"name":"Placebo","n":126,"value":5.8}],"source":"https://doi.org/10.1016/S1470-2045(21)00630-6"}],"replication":"PACIFIC showed the same effect after concurrent chemoradiotherapy with durvalumab; GEMSTONE-301 is the extension to sequential treatment."},"route":"/trials/gemstone-301/","neighbours":{"cancer":[{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"stage-iii-unresectable-nsclc","kind":"cancer","name":"Unresectable stage III non-small-cell lung cancer","route":"/cancers/stage-iii-unresectable-nsclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"},{"id":"imrt-igrt","kind":"technology","name":"IMRT / IGRT (modern external beam)","route":"/technologies/imrt-igrt/"}],"target":[{"id":"pdl1","kind":"target","name":"PD-L1","route":"/targets/pdl1/"}],"drug":[{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"sugemalimab","kind":"drug","name":"Sugemalimab","route":"/drugs/sugemalimab/"}],"company":[{"id":"cstone","kind":"company","name":"CStone Pharmaceuticals","route":"/companies/cstone/"}],"term":[{"id":"chemoradiation","kind":"term","name":"Chemoradiation (chemoradiotherapy, CRT)","route":"/terms/chemoradiation/"},{"id":"consolidation-therapy","kind":"term","name":"Consolidation therapy","route":"/terms/consolidation-therapy/"}],"trial":[{"id":"pacific","kind":"trial","name":"PACIFIC","route":"/trials/pacific/"},{"id":"pacific-2","kind":"trial","name":"PACIFIC-2","route":"/trials/pacific-2/"}]}}