CA209-7AL is a randomized,multicenter,phase 2 trial evaluating the efficacy and safety of consolidative nivolumab(NIVO)versus observation following neoadjuvant NIVO plus chemotherapy and concurrent chemoradiotherapy(C...CA209-7AL is a randomized,multicenter,phase 2 trial evaluating the efficacy and safety of consolidative nivolumab(NIVO)versus observation following neoadjuvant NIVO plus chemotherapy and concurrent chemoradiotherapy(CCRT)for unresectable stage Ⅲ NSCLC.Patients received 2 cycles of neoadjuvant chemo-NIVO therapy(docetaxel+cisplatin+NIVO)and CCRT(total dose 54–64 Gy).Post-CCRT,eligible patients were randomized 1:1 to receive consolidative NIVO(360 mg every 3 weeks for up to 12 months)or observation.The primary endpoint was progression-free survival(PFS)from randomization.Between December 3rd,2019,and August 18th,2023,264 patients were enrolled,and 172 were randomized to NIVO consolidation(n=86)or observation(n=86).With a median follow-up of 22·8 months,NIVO consolidation resulted in significantly longer PFS than did observation(median not reached vs.12.2 months[95%CI 10.2–20.8];stratified hazard ratio 0·49[95%CI 0.30–0.79],p=0.003).NIVO consolidation also demonstrated superior PFS compared with a parallel real-world study,where patients received CCRT followed by consolidative immunotherapy(median PFS:15.7 months[95%CI 11.9-NA]).Grade 3 or 4 toxicities occurred in 9.3%of patients in the consolidation group versus 4·6%in the observation group,with similar rates of pneumonitis(2.3%each)and proximal bronchial tree toxicity(3.5%vs.2.3%).Treatment-related death occurred in 1(1.2%)patient in the consolidation group because of pneumonitis.Patients with a high TMB had a longer PFS with consolidation(NR vs.15.2 months,p=0.042).Consolidative NIVO following neoadjuvant NIVO plus chemotherapy and CCRT demonstrated effectiveness and tolerability for patients with unresectable stage Ⅲ NSCLC(ClinicalTrials.gov NCT04085250).展开更多
基金funded by Bristol Myers Squibb(CA209-7AL)funding from Varian Medical Systems,Elekta Medical Systemsthe Guangdong Association Study of Thoracic Oncology(GASTO-1091).
文摘CA209-7AL is a randomized,multicenter,phase 2 trial evaluating the efficacy and safety of consolidative nivolumab(NIVO)versus observation following neoadjuvant NIVO plus chemotherapy and concurrent chemoradiotherapy(CCRT)for unresectable stage Ⅲ NSCLC.Patients received 2 cycles of neoadjuvant chemo-NIVO therapy(docetaxel+cisplatin+NIVO)and CCRT(total dose 54–64 Gy).Post-CCRT,eligible patients were randomized 1:1 to receive consolidative NIVO(360 mg every 3 weeks for up to 12 months)or observation.The primary endpoint was progression-free survival(PFS)from randomization.Between December 3rd,2019,and August 18th,2023,264 patients were enrolled,and 172 were randomized to NIVO consolidation(n=86)or observation(n=86).With a median follow-up of 22·8 months,NIVO consolidation resulted in significantly longer PFS than did observation(median not reached vs.12.2 months[95%CI 10.2–20.8];stratified hazard ratio 0·49[95%CI 0.30–0.79],p=0.003).NIVO consolidation also demonstrated superior PFS compared with a parallel real-world study,where patients received CCRT followed by consolidative immunotherapy(median PFS:15.7 months[95%CI 11.9-NA]).Grade 3 or 4 toxicities occurred in 9.3%of patients in the consolidation group versus 4·6%in the observation group,with similar rates of pneumonitis(2.3%each)and proximal bronchial tree toxicity(3.5%vs.2.3%).Treatment-related death occurred in 1(1.2%)patient in the consolidation group because of pneumonitis.Patients with a high TMB had a longer PFS with consolidation(NR vs.15.2 months,p=0.042).Consolidative NIVO following neoadjuvant NIVO plus chemotherapy and CCRT demonstrated effectiveness and tolerability for patients with unresectable stage Ⅲ NSCLC(ClinicalTrials.gov NCT04085250).
