A Study of HLX10 in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04 Compared With Carboplatin+Pemetrexed in 1L Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Summary

This study involves a two-part design. Part 1 is designed to evaluate the safety and tolerability of the 4 drug (HLX10+HLX04+carboplatin+pemetrexed). Part 2 is a randomized, open-label study, which will evaluate the safety and efficacy of HLX10 in combination with carboplatin+pemetrexed with or without HLX04(biosimilar of avastin) compared with treatment with carboplatin+pemetrexed in 1st line Stage IIIB/IIIC or IV non-squamous NSCLC. Participants will be randomized in a 1:1:1 ratio to Arm A (HLX10+HLX04+Carboplatin+Pemetrexed), Arm B (HLX10+HLX04 placebo+Carboplatin+Pemetrexed), or Arm C (HLX10 placebo + HLX04 placebo+Carboplatin+Pemetrexed).

Timeline

Start

2019-12-02

Primary completion

2023-10-01

Completion

2024-03-15

Publications

• Hao X, Wang L, Hao Y, Hu Y, Chen C, Chen B, Huang Y, Zang A, Wang Y, Chen Z, Zhuang W, Shi J, Ren X, Nie L, Yu G, Luo F, Mao Y, Wang X, Li B, Bai Y, Shi J, Ni H, Hou X, Yu H, Li J, Wang Q, Zhu J, Shi Y; ASTRUM-002 Study Group. Serplulimab Plus Chemotherapy, with or without HLX04, versus Chemotherapy as First-Line Treatment for Nonsquamous NSCLC: Final Survival Analysis of the Phase III ASTRUM-002 Study. Cancer Commun (Lond). 2026 Jun 10;46:0034. doi: 10.34133/cancomm.0034. eCollection 2026.
• Wang L, Hao X, Hao Y, Hu Y, Chen C, Chen B, Huang Y, Zang A, Wang Y, Chen Z, Zhuang W, Shi J, Ren X, Nie L, Yu G, Luo F, Mao Y, Wang X, Li B, Bai Y, Shi J, Ni H, Yu H, Li J, Wang Q, Zhu J, Shi Y; ASTRUM-002 Study Group. First-line serplulimab plus chemotherapy with or without HLX04 versus chemotherapy in locally advanced or metastatic non-squamous non-small-cell lung cancer (ASTRUM-002): a randomised, double-blind, multicentre phase 3 trial. Lancet Respir Med. 2026 Feb;14(2):117-128. doi: 10.1016/S2213-2600(25)00263-2. Epub 2025 Dec 4.
• Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.

Drugs

Indications