sintillimab plus SoC (n=266) vs. placebo plus SoC (n=131)
randomized controlled trial
Sintilimab plus pemetrexed plus platine
Sintilimab 200 mg was intravenously (IV) administered on day 1 of each cycle, once every 3 weeks (Q3W)
placebo plus pemetrexed plus platine
placebo was intravenously (IV) administered on day 1 of each cycle, once every 3 weeks (Q3W)
Patients in the placebo-combination group were eligible to cross over to receive sintilimab
mNSCLC - L1 - all population
including patient ineligible for radical surgery or radiotherapy, who had no sensitive EGFR mutations or anaplastic lymphoma kinase (ALK) rearrangements
double blind
47 hospitals in the People’s Republic of China.
P3/ one sided and one interim analysis. Only PFS tested stopped at AI1
AI 1 stopped : In Chinese patients with previously untreated, locally advanced or metastatic nonsquamous NSCLC, the addition of sintilimab to chemotherapy with pemetrexed and platinum resulted in considerably longer PFS than with chemotherapy alone