A phase Ib study evaluating the safety and efficacy of IBI310 plus sintilimab in patients with advanced non-small-cell lung cancer who have progressed after anti-PD-1/L1 therapy.

"data s1."

"CONFLICT OF INTEREST STATEMENT Yuguang Zhao, Xiao Chen, Jun Yao, Jianlin Long, Yong Mao, Di Wu, Aimin Zang, Jun Zhao, Ziling Liu, Rui Meng, Jiuwei Cui declared their institutions received study grants from Innovent Biologics, Inc., China. Ye Chen, Yang Luo, Qun Guo, Li Li, reported being employees of Innovent Biologics, Inc. Funding for the submitted work was as described above."

"FUNDING INFORMATION Funding for our study was provided by Innovent Biologics, Inc., Suzhou, Jiangsu, China. The authors and funder were involved in study design, collection, analysis, and interpretation of data and medical writing support. The funder maintained the study database."

"This multicenter, open label, phase I study was registered with ClinicalTrials.gov (NCT NCT05118334). Eligible patients were randomly assigned (1:1) to receive either IBI310 (1 mg/kg Q3W) or IBI310 (3 mg/kg Q3W) in combination with sintilimab (200 mg Q3W) (hereinafter cohort A and cohort B, respectively). Patients would receive assigned treatment until progressive disease (PD), intolerable toxicity, withdrawal of informed consent, death, or for up to a maximum of 2 years, whichever occurred first. The primary of the phase 1 study endpoints were objective response rate (ORR) (complete response [CR] or partial response [PR]) assessed by investigator per RECIST v1.1 and safety. The second endpoints included duration of response (DoR), progression‐free survival (PFS) and overall survival (OS)."