ASTRUM-002
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)
- NCT03952403 ↗
- Unknown
- Shanghai Henlius Biotech
- Focused
We haven't built an HCP commentary report on ASTRUM-002 (serplulimab plus bevacizumab; serplulimab in first-line advanced non-squamous NSCLC) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on ASTRUM-002 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 4 | |
| Podcasts | 1 |
The trial
ClinicalTrials.gov- Official title
- A Three Arm, Randomized, Double-Blind, Multicenter, Phase 3 Study of HLX10(Anti-PD-1 Antibody) in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04(Avastin Biosimilar) Compared With Carboplatin+Pemetrexed in 1L Stage IIIB/IIIC or IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
- Phase
- Phase 3
- Status
- Unknown
- Conditions
- Carcinoma; Non-Small-Cell Lung
- Interventions
- HLX10, an engineered anti-PD-1 antibody; HLX04, a bevacizumab biosimilar; Carboplatin; Pemetrexed
- Arms
- Part 1-Cohort 1 (HLX10+HLX04+Carboplatin+Pemetrexed) · Experimental
- Part 2-Arm A (HLX10+HLX04+Carboplatin+Pemetrexed) · Experimental
- Part 2-Arm B (HLX10+HLX04 placebo+Carboplatin+Pemetrexed) · Experimental
- Part 2-Arm C (HLX10 placebo+HLX04 placebo+Carboplatin+Pemetrexed) · Active comparator
- Enrollment
- 643
- Primary outcomes
- Part 1 Safety and tolerability of study treatment
- Part 2-Progression Free Survival (PFS) as Determined by the IRRC using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- Sponsor
- Shanghai Henlius Biotech
- Start
- Dec 2, 2019
- Primary completion
- Oct 1, 2023 (estimated)
- Results posted
- No
- Registry record
- NCT03952403 · updated Aug 8, 2023
Publications
linked from the registry- 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. PubMed 42282892
- 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. PubMed 41354044
- 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. PubMed 40932107