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The sponsor's R&D strategy is adjusted.
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| Name | Class |
|---|---|
| Shanghai Chest Hospital | OTHER |
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This is a randomized, open-label, multi-center, phase II trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus Pemetrexed and Carboplatin in Subjects with KRAS mutant stage IV non-squamous Non-small Cell Lung Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210 +apatinib | Experimental | subject will receive SHR-1210 200mg every 2 weeks, apatinib 250mg every day |
|
| chemotherapy | Active Comparator | Pemetrexed 500mg/m2, Day 1 of each 21 day, 4 cycles carboplatin AUC 5 on Day 1 of each 21 day, 4 cycles followed by pemetrexed 500mg/m2 until progression Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 | Drug | Subjects receive SHR-1210 intravenous every 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Progression-Free Survival (PFS) as Assessed by the Independent Review Committee Using RECIST v1.1 | PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the Independent Review Committee Using RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment. | up to approximately 40 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 | Time Frame: Baseline until PD or death, whichever occurs first | up to approximately 40 months |
| Duration of Overall Survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
KRAS mutant
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| Name | Affiliation | Role |
|---|---|---|
| Jianjun Zou, MD, PhD | Jiangsu HengRui Medicine Co., Ltd. | Study Director |
| Shun Lu, MD, PhD | Jiaotong University,Shanghai chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200120 | China |
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| Apatinib |
| Drug |
Subjects receive Apatinib orally every day |
|
| Pemetrexed | Drug | Subjects receive Pemetrexed intravenous every 3 weeks |
|
| Carboplatin | Drug | subjects receive carboplatin intravenous every 3 weeks |
|
Baseline until death from any cause
| up to approximately 40 months |
| Objective Response Rate (ORR) | The percentage of patients with CR and PR assessed by investigators according to Recist v 1.1. | up to approximately 40 months |
| disease control rate (DCR) | The proportion of patients who have achieved complete response, partial response and Stable disease assessed by investigators according to Recist v 1.1. | up to approximately 40 months |
| Duration of response (DoR) | Duration of response (DoR) | up to approximately 40 months |
| Adverse events (AEs) | All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 5.0 | up to approximately 40 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 |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| D000068437 | Pemetrexed |
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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