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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20181429 | Other Identifier | www.chinadrugtrials.org.cn |
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This is a randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of CS1001 in subjects with locally advanced/unresectable (Stage III) non-small cell lung cancer that has not progressed after prior concurrent/sequential chemoradiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS1001monoclonal 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progress Free Survival (PFS) | The primary endpoint is the PFS of CS1001 versus placebo (evaluated by blinded independent central review(BICR) according to response evaluation criteria in solid tumors RECIST v1.1). | from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to 30 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing Zhou | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35038429 | Derived | Zhou Q, Chen M, Jiang O, Pan Y, Hu D, Lin Q, Wu G, Cui J, Chang J, Cheng Y, Huang C, Liu A, Yang N, Gong Y, Zhu C, Ma Z, Fang J, Chen G, Zhao J, Shi A, Lin Y, Li G, Liu Y, Wang D, Wu R, Xu X, Shi J, Liu Z, Cui N, Wang J, Wang Q, Zhang R, Yang J, Wu YL. Sugemalimab versus placebo after concurrent or sequential chemoradiotherapy in patients with locally advanced, unresectable, stage III non-small-cell lung cancer in China (GEMSTONE-301): interim results of a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):209-219. doi: 10.1016/S1470-2045(21)00630-6. Epub 2022 Jan 14. |
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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 by intravenous infusion every 3 weeks, for up to 24 months |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |