A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer

Phase 3 Completed 350 enrolled Akeso Akeso Tiancheng, Inc · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a phase III, randomized, double-blinded, multicenter clinical study to evaluate the efficiency and safety of AK105 (Anti-PD1 antibody) plus paclitaxel and carboplatin vs placebo plus paclitaxel and carboplatin as First-line Therapy in patients with metastatic squamous non-small cell lung cancer.

Timeline

Start: 2018-12-20
Primary completion: 2020-10-08
Completion: 2022-01-14

Outcome

Met primary endpoint

paper the penpulimab group showed an improved progression-free survival compared with the placebo group PMID 38309287 ↗

paper median 7·6 months, 95% CI 6·8--9·6 vs 4·2 months, 95% CI 4·2-4·3; HR 0·43, 95% CI 0·33-0·56; p<0·0001 PMID 38309287 ↗

paper 8·1 months, 5·7-9·7 vs 4·2 months, 4·1-4·3; HR 0·37, 0·27-0·52, p<0·0001 PMID 38309287 ↗

Publications

Zhong H, Sun S, Chen J, Wang Z, Zhao Y, Zhang G, Chen G, Zhou M, Zhou J, Du Y, Wu L, Xu Z, Mei X, Zhang W, He J, Cui J, Zhang Z, Luo H, Liu W, Sun M, Wu J, Shen Y, Zhang S, Yang N, Wang M, Lu J, Li K, Yao W, Sun Q, Yue H, Wang L, Ye S, Li B, Zhuang X, Pan Y, Zhang M, Shu Y, He Z, Pan L, Ling Y, Liu S, Zhang Q, Jiao S, Han B. First-line penpulimab combined with paclitaxel and carboplatin for metastatic squamous non-small-cell lung cancer in China (AK105-302): a multicentre, randomised, double-blind, placebo-controlled phase 3 clinical trial. Lancet Respir Med. 2024 May;12(5):355-365. doi: 10.1016/S2213-2600(23)00431-9. Epub 2024 Jan 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Penpulimab	Monoclonal antibody	200 mg	Intravenous
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Paclitaxel	Small molecule	175 mg/m2	Intravenous