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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1-Cohort 1 (HLX10+HLX04+Carboplatin+Pemetrexed) | Experimental | Participants will receive IV infusion of HLX10 and HLX04 on Day 1 of each 21-day cycle followed by IV infusion of Carboplatin and Pemetrexed on Day 1 of each 21-day cycle for 4 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of HLX10 until loss of clinical benefit and HLX04 and Pemetrexed until progressive disease, unacceptable toxicity, or death during maintenance treatment phase. |
|
| Part 2-Arm A (HLX10+HLX04+Carboplatin+Pemetrexed) | Experimental | Participants will receive IV infusion of HLX10 and HLX04 on Day 1 of each 21-day cycle followed by IV infusion of Carboplatin and Pemetrexed on Day 1 of each 21-day cycle for 4 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of HLX10 until loss of clinical benefit and HLX04 and Pemetrexed until progressive disease, unacceptable toxicity, or death during maintenance treatment phase. |
|
| Part 2-Arm B (HLX10+HLX04 placebo+Carboplatin+Pemetrexed) | Experimental | Participants will receive IV infusion of HLX10 and HLX04 placebo on Day 1 of each 21-day cycle followed by IV infusion of Carboplatin and Pemetrexed on Day 1 of each 21-day cycle for 4 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion of HLX10 until loss of clinical benefit and Pemetrexed until progressive disease, unacceptable toxicity, or death during maintenance treatment phase. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX10, an engineered anti-PD-1 antibody | Drug | HLX10 will be administered as IV infusion at a dose of 4.5mg/kg on Day 1 of each 21-day cycle until loss of clinical benefit or up to 2 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 Safety and tolerability of study treatment | baseline to 21 days | |
| Part 2-Progression Free Survival (PFS) as Determined by the IRRC using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Baseline until disease progression or death, whichever occurs first (up to approximately 24months) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2-Overall survival (OS), as a major secondary endpoint | Baseline until death (up to approximately 36 months) | |
| Part 1 and 2-Incidence rates of AEs and SAEs | Baseline up to approximately 36months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yankai Shi, professor | Cancer Hospital Chinese Academy of Medical Sciences (CAMS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences (CAMS) | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42282892 | Derived | 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. | |
| 41354044 |
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|
| Part 2-Arm C (HLX10 placebo+HLX04 placebo+Carboplatin+Pemetrexed) | Active Comparator | Participants will receive IV infusion of HLX10 placebo and HLX04 placebo on Day 1 of each 21-day cycle followed by IV infusion of Carboplatin and Pemetrexed on Day 1 of each 21-day cycle for 4 cycles or until loss of clinical benefit whichever occurs first, during induction treatment phase. Participants will receive IV infusion Pemetrexed until progressive disease, unacceptable toxicity, or death during maintenance treatment phase. |
|
| HLX04, a bevacizumab biosimilar | Drug | HLX04 will be administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, death or up to 2 year. |
|
| Carboplatin | Drug | Carboplatin will be administered at area under the concentration-time curve (AUC) 5 on Day 1 of each 21-day cycle for 4 cycles, or until loss of clinical benefit whichever occurs first. |
|
| Pemetrexed | Drug | Pemetrexed will be administered as IV infusion at a dose of 500 milligrams per square meter (mg/m2) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, death or up to 2 year. |
|
| Part 1-Overall survival (OS) | Baseline up to approximately 36months |
| Part 1 and Part 2-PFS (assessed by the investigator according to RECIST v1.1) in Part 1 and 2; PFS (assessed by IRRC according to RECIST v1.1) in Part 1 | Baseline until disease progression or death, whichever occurs first (up to approximately 36months) |
| Part 1 and 2-Objective response rate (ORR, assessed by IRRC and investigator according to RECIST v1.1 criteria) | Baseline up to approximately 36 months |
| Part 1 and 2-Duration of response (DOR, assessed by IRRC and investigator according to RECIST v1.1 criteria) | Baseline up to approximately 36 months |
| Part 2-PFS2 (assessed by IRRC) | Baseline up to approximately 36months |
| Part 1 and 2-Pharmacokinetics (PK): serum HLX10 concentration | Baseline up to approximately 36 months |
| Part 1 and 2-Immunogenicity evaluation: positive anti-drug antibody (ADA) rate | Baseline up to approximately 36 months |
| Part 1 and 2-PD-L1 expression level | Baseline |
| Part 1 and 2-Microsatellite instability(MSI) | Baseline |
| Part 1 and 2-Tumor mutation burden(TMB) | Baseline |
| Derived |
| 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. |
| 40932107 | Derived | 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. |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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