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The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy in adjuvant treatment of stage II-IIIB NSCLC without EGFR-sensitizing mutations and ALK fusions after complete surgical resection.The subjects were randomly divided into two groups according to 1:1, with about 316 subjects in the experimental group and the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706 plus Platinum-based chemotherapy | Experimental | QL1706(5mg/kg Q3W IV) plus Platinum-based chemotherapy |
|
| Placebo plus Platinum-based chemotherapy | Placebo Comparator | Placebo(5mg/kg Q3W IV) plus Platinum-based chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 injection | Drug | QL1706(5mg/kg Q3W IV) concomitantly with Platinum-based chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS) in the PD-L1 ≥1% Population, Assessed by Investigator. | DFS was defined as the time from randomization to first recurrence of NSCLC, appearance of new primary NSCLC, or death from any cause, whichever occurred first. Tumor recurrence includes local recurrence and distant metastasis. | Up to approximately 84 months |
| Disease-free Survival (DFS) in the ITT Population, Assessed by Investigator. | Up to approximately 84 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from random to death from any cause. OS will be measured in the PD-L1 subpopulation and in the ITT population. | Up to approximately 108 months |
| Percentage of Participants Who are Survival at Year 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiusong Qiu | Contact | 86-13918736645 | xiusong.qiu@qilu-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Caicun Zhou, MD, PhD | Shanghai Pulmonary Hospital, Shanghai, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital, Shanghai. China | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37158938 | Derived | Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1. |
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| Vinorelbine Tartrate | Drug | Vinorelbine 25mg/m2（D1、D8）Q3W IV, 2-4 cycles |
|
| Paclitaxel | Drug | Paclitaxel 175mg/m2（D1） Q3W IV, 2-4 cycles |
|
| Cisplatin | Drug | Cisplatin 75mg/m2（D1）Q3W IV, 2-4 cycles |
|
| Carboplatin | Drug | Carboplatin AUC=5（D1） Q3W IV, 2-4 cycles |
|
| Pemetrexed | Drug | Pemetrexed 500mg/m2（D1） Q3W IV, 2-4 cycles |
|
| Placebo | Drug | Placebo |
|
OS rates will be measured in the PD-L1 subpopulation and in the ITT population.
| Year 4 |
| Percentage of Participants Who are Disease-Free at Year 3 | DFS rates will be measured in the PD-L1 subpopulation and in the ITT population. | Year 3 |
| Percentage of Participants Who are Disease-Free at Year 5 | DFS rates will be measured in the PD-L1 subpopulation and in the ITT population. | Year 5 |
| DFS Within Selected Populations | Assessed by Investigator | Up to approximately 108 months |
| Percentage of Participants with Adverse Events and Serious Adverse Events | Up to approximately 108 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077235 | Vinorelbine |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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