ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors

Summary

The goal of this Phase 3 clinical trial is to study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

Timeline

Start

2023-06-28

Primary completion

2027-08-31

Completion

2028-08-31

Publications

• Background Zhang Y, Du X, Liu M, Tang F, Zhang P, Ai C, Fields JK, Sundberg EJ, Latinovic OS, Devenport M, Zheng P, Liu Y. Hijacking antibody-induced CTLA-4 lysosomal degradation for safer and more effective cancer immunotherapy. Cell Res. 2019 Aug;29(8):609-627. doi: 10.1038/s41422-019-0184-1. Epub 2019 Jul 2.
• Background Liu Y, Zheng P. Preserving the CTLA-4 Checkpoint for Safer and More Effective Cancer Immunotherapy. Trends Pharmacol Sci. 2020 Jan;41(1):4-12. doi: 10.1016/j.tips.2019.11.003. Epub 2019 Dec 10.
• Results Cho BC, Balaraman R, Chen HJ, Yu X, Fawole A, Liu ZG, Zhang J, Wu L, Yang B, Leddon JL, Hamm J, Huang Y, Wu L, Pan P, Singh P, Beardsley A, Kayali F, Davarifar A, Lee KH, Park KU, Lee Y, Li L, Wang X, Sun M, Yu Y, Jain V, Shpyro S, Wang Q, Wenger M, Sahin U, Efuni S, Song S, He K, Zheng P, Liu Y, He K, Li T, Socinski MA, Wu YL. Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial. Nat Med. 2026 Jun;32(6):2245-2253. doi: 10.1038/s41591-026-04323-8. Epub 2026 Mar 27.

Drugs

Indications