A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer

Summary

The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with high levels of programmed cell death ligand-1 (PD-L1), locally advanced/recurrent or untreated metastatic non-small cell lung cancer (NSCLC).

Timeline

Start

2021-05-24

Primary completion

2025-05-30

Completion

2026-03-18

Outcome

Missed primary endpoint

Stopped: “This decision was conducted by the sponsor based on lack of efficacy and not driven by safety concerns.”

paper Ociperlimab plus tislelizumab showed no improvement in OS versus pembrolizumab; median OS was comparable across arms. PMID 42448175 ↗

registry p = 0.4050; Hazard Ratio (HR) 0.97 (95% CI 0.76 to 1.23); Log Rank NCT04746924 ↗

Publications

• Socinski MA, Reck M, Paz-Ares L, Nishio M, Spira AI, Yu X, Melkadze T, Zeng A, Martinez-Bueno A, Li X, Arulananda S, Zuo Y, Chica-Duque S, Dai W, Zhou J, Tan W, Lu S. AdvanTIG-302: Phase 3 Study of Ociperlimab (Anti-TIGIT) + Tislelizumab (Anti-PD-1) Versus Pembrolizumab in Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer With PD-L1 >/=50. J Thorac Oncol. 2026 Jul 14:104089. doi: 10.1016/j.jtho.2026.104089. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ociperlimab	Monoclonal antibody	900 mg	Intravenous
Comparator	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Tislelizumab	Monoclonal antibody	200 mg	Intravenous

Indications