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The study is being conducted to evaluate the efficacy and safety of Camrelizumab (200mg,q2w) combined with Apatinib(250mg qd) in subjects with PD-L1 positive relapsed or advanced non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab 200mg + Apatinib Mesylate 250mg | Experimental | Camrelizumab 200mg q2w ivgtt+ Apatinib Mesylate 250mg once daily po qd |
|
| Camrelizumab 200mg | Experimental | Camrelizumab 200mg q2w ivgtt |
|
| Pemetrexed/Paclitaxel injection+ Carboplatin | Active Comparator | For non-squamous NSCLC: Pemetrexed disodium for injection + Carboplatin; For squamous NSCLC: Paclitaxel injection + Carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab 200mg | Biological | Camrelizumab 200mg q2w ivgtt |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) assessed by Independent review committee (IRC) | Progression Free Survival, defined as the time from randomization to the first occurrence of disease progression as determined by IRC with use of Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death from any cause, whichever occurs first. | up to 2 years |
| Overall survival | Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by investigator | Progression-Free-Survival | up to 2 years |
| Objective Response Rate | Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quanren Wang, PhD | Contact | 18036618570 | wangquanren@hrglobe.cn | |
| Weixia Li, Master | Contact | 15005136260 | liweixia@hrglobe.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33323401 | Derived | Zhou C, Wang Y, Zhao J, Chen G, Liu Z, Gu K, Huang M, He J, Chen J, Ma Z, Feng J, Shi J, Yu X, Cheng Y, Yao Y, Chen Y, Guo R, Lin X, Wang Z, Gao G, Wang Q, Li W, Yang X, Wu L, Zhang J, Ren S. Efficacy and Biomarker Analysis of Camrelizumab in Combination with Apatinib in Patients with Advanced Nonsquamous NSCLC Previously Treated with Chemotherapy. Clin Cancer Res. 2021 Mar 1;27(5):1296-1304. doi: 10.1158/1078-0432.CCR-20-3136. Epub 2020 Dec 15. |
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| Apatinib Mesylate 250mg | Drug | Apatinib Mesylate 250mg po qd |
|
| Pemetrexed disodium for injection | Drug | Pemetrexed disodium for injection 500 mg/m2 q3w |
|
| Paclitaxel injection | Drug | Paclitaxel injection 175 mg/m2 q3w |
|
| Carboplatin | Drug | Carboplatin AUC 5 mg/mL/min q3w |
|
| At the time point of every 6 weeks,up to 2 years |
| Disease Control Rate | Disease Control Rate, determined using RECIST v1.1 criteria | At the time point of every 6 weeks,up to 2 years |
| Duration of Response | Duration of Response, determined using RECIST v1.1 criteria | Up to 2 years |
| Time to Treatment Failure | Time to Treatment Failure, defined as the time from randomization to treatment discontinuation. | Up to 2 years |
| Adverse Events and Serious Adverse Events | Adverse Events and Serious Adverse Events | from the first drug administration to within 90 days for the last Camrelizumab dose |
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| D000068437 | Pemetrexed |
| D007267 | Injections |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| 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 |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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