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This is a multi-center, randomized, double-blind, phase III study to evaluate the efficacy and safety of CS1001 in combination with platinum-containing chemotherapy versus placebo in combination with chemotherapy in first-line treatment-naive subjects with stage IV non-small cell lung cancer (NSCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS1001 monoclonal antibody | Experimental |
| |
| CS1001 placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS1001 monoclonal antibody | Biological | Participant will receive CS1001 monoclonal antibody 1200 mg by intravenous infusion every 3 weeks, for up to 24 months; Drug Carboplatin on Day 1 of each 21-day cycle; Drug Pemetrexed on Day 1 of each 21-day cycle; Drug Paclitaxel on Day 1 of each 21-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) in all subjects evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS defined as the time from randomization to all-cause death. | up to approximately 7 years |
| PFS assessed by BICR | PFS defined as the time from randomization to the first occurrence of disease progression or all-cause death (whichever occurs first), as determined by the BICR according to RECIST v1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40523368 | Derived | Zhou C, Wang Z, Sun M, Cao L, Ma Z, Wu R, Yu Y, Yao W, Sun S, Chen J, Zhuang W, Cui J, Chen X, Lu Y, Shen H, Hu C, Liu J, Liu Y, Wang M, Li X, Sun P, Shu Y, Zhou J, Li J, Gu K, Wang C, Zhao H, Zhang Y, Liu C, Yang H, Zhang X, Ma R, Li L, Liang L, Li M, Wang J, Wang Q, Wang B, Dai H, Shi Q, Yang J. Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): 4-year outcomes from a double-blind, randomised, phase 3 trial. Lancet Oncol. 2025 Jul;26(7):887-897. doi: 10.1016/S1470-2045(25)00198-6. Epub 2025 Jun 13. | |
| 37322367 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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|
| CS1001 placebo | Biological | Participant will receive CS1001 placebo 1200 mg by intravenous infusion every 3 weeks, for up to 24 months; Drug Carboplatin on Day 1 of each 21-day cycle; Drug Pemetrexed on Day 1 of each 21-day cycle; Drug Paclitaxel on Day 1 of each 21-day cycle |
|
| up to approximately 5 years |
| PFS in subgroup of participants with PD-L1 Expression≥1%, as determined by the investigator | PFS after randomization as determined by the investigator according to RECIST v1.1 in the subgroup of patients with PD-L1 expression ≥1% defined by the SP263 immunohistochemistry (IHC) assay. | up to approximately 5 years |
| Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1 | ORR, defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions >=4 weeks apart, as determined by the investigator according to RECIST v1.1. | up to approximately 5 years |
| Duration of response (DOR) assessed by the investigator according to RECIST v1.1 | DOR defined as the time between the date of the earliest qualifying response and the date of progressive disease or all-cause death, whichever occurs first, as determined by the investigator according to RECIST v1.1. | up to approximately 5 years |
| Safety and tolerability of CS1001 or placebo in combination with platinum-based chemotherapy | up to approximately 5 years |
| Pharmacokinetics (PK) and immunogenecity of CS1001 | up to approximately 5 years |
| Efficacy of CS1001 monotherapy in subjects cross over to receive CS1001 who experienced progressive disease after assigned to the placebo group in the double-blind phase (CS1001 or placebo in combination with chemotherapy) | up to approximately 5 years |
| Derived |
| Zhou C, Wang Z, Sun M, Cao L, Ma Z, Wu R, Yu Y, Yao W, Sun S, Chen J, Zhuang W, Cui J, Chen X, Lu Y, Shen H, Hu C, Liu J, Liu Y, Wang M, Li X, Sun P, Shu Y, Zhou J, Li J, Gu K, Wang C, Zhao H, Zhang Y, Liu C, Wang J, Chen R, Qin M, Wang H, Yang J. Interim survival analysis of the randomized phase III GEMSTONE-302 trial: sugemalimab or placebo plus chemotherapy as first-line treatment for metastatic NSCLC. Nat Cancer. 2023 Jun;4(6):860-871. doi: 10.1038/s43018-023-00578-z. Epub 2023 Jun 15. |
| 35038432 | Derived | Zhou C, Wang Z, Sun Y, Cao L, Ma Z, Wu R, Yu Y, Yao W, Chang J, Chen J, Zhuang W, Cui J, Chen X, Lu Y, Shen H, Wang J, Li P, Qin M, Lu D, Yang J. Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial. Lancet Oncol. 2022 Feb;23(2):220-233. doi: 10.1016/S1470-2045(21)00650-1. Epub 2022 Jan 14. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |