{"entity":{"id":"gemstone-302","kind":"trial","name":"GEMSTONE-302","aka":[],"tldr":"The trial behind sugemalimab's approval in China and later Europe, showing a PD-L1 antibody plus chemotherapy delays progression in both main types of lung cancer.","summary":"479 patients randomised 2:1. Median progression-free survival 7.8 versus 4.9 months (hazard ratio 0.50) at the interim analysis, with benefit in squamous and non-squamous histology and across PD-L1 levels; overall survival favoured sugemalimab at the final analysis. NMPA approval December 2021; European Commission approval July 2024, the first EU approval of a Chinese-developed PD-L1 antibody.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT03789604","url":"https://clinicaltrials.gov/study/NCT03789604"},{"label":"Lancet Oncol 2022","url":"https://doi.org/10.1016/S1470-2045(21)00650-1"}],"tags":["china"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["sugemalimab"],"companies":["cstone"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["zhou-caicun"],"bottlenecks":[],"keyPapers":["paper-gemstone-302-lancet-oncol-2022","paper-gemstone-302-nat-cancer-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03789604","phase":"3","setting":"First-line metastatic squamous and non-squamous NSCLC without EGFR, ALK, ROS1 or RET alterations, China: sugemalimab or placebo plus platinum chemotherapy","sponsor":"CStone Pharmaceuticals","result":"PFS 7.8 vs 4.9 months, HR 0.50.","started":"2018-12-13","startedType":"actual","yearReported":2022,"enrolled":479,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Sugemalimab + chemotherapy","n":320,"value":7.8},{"name":"Placebo + chemotherapy","n":159,"value":4.9}],"hr":0.5,"source":"https://doi.org/10.1016/S1470-2045(21)00650-1"}]},"route":"/trials/gemstone-302/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"sugemalimab","kind":"drug","name":"Sugemalimab","route":"/drugs/sugemalimab/"}],"company":[{"id":"cstone","kind":"company","name":"CStone Pharmaceuticals","route":"/companies/cstone/"}],"person":[{"id":"zhou-caicun","kind":"person","name":"Caicun Zhou","route":"/people/zhou-caicun/"}],"paper":[{"id":"paper-gemstone-302-nat-cancer-2023-update","kind":"paper","name":"Interim survival analysis of the randomized phase III GEMSTONE-302 trial: sugemalimab or placebo plus chemotherapy as first-line treatment for metastatic NSCLC","route":"/key-papers/paper-gemstone-302-nat-cancer-2023-update/"},{"id":"paper-gemstone-302-lancet-oncol-2022","kind":"paper","name":"Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial","route":"/key-papers/paper-gemstone-302-lancet-oncol-2022/"}]}}