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Terminated by Sponsor
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The study is being conducted to evaluate the efficacy and safety of SHR-1210 in combination with Famitinib plus chemotherapy in subjects with NSCLC.
The study is being conducted to evaluate the efficacy and safety of Camrelizumab in combination with Famitinib plus chemotherapy in subjects with NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | Intervention Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib |
|
| Treatment group B | Placebo Comparator | Intervention Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab;Pemetrexed and Carboplatin; Famitinib; | Drug | Part 1: Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib Part 2: Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1:Serum concentrations of Camrelizumab | Cycle 2; each cycle is 21 days (up to 42 days) | |
| Part 1:Plasma concentrations of Famitinib | Cycle 2; each cycle is 21 days (up to 42 days) | |
| Part 1:Area Under the Plasma Concentration Versus Time Curve (AUC) of Famitinib. | Cycle 2; each cycle is 21 days (up to 42 days) | |
| Part 1:Maximum Concentration (Cmax) of Famitinib. | Cycle 2; each cycle is 21 days (up to 42 days) | |
| Part 1:Time to Maximum Concentration (Tmax) of Famitinib. | Cycle 2; each cycle is 21 days (up to 42 days) | |
| Part 1:Half-life (t1/2 z) of Famitinib. | Cycle 2; each cycle is 21 days (up to 42 days) | |
| Part 1:Apparent Clearance (CL/F) of Famitinib | Cycle 2; each cycle is 21 days (up to 42 days) | |
| Part 1:Vz/F of Famitinib. | Cycle 2; each cycle is 21 days (up to 42 days) | |
| Part 2: Progression-free Survival (PFS) as Assessed by BICR according to RECIST 1.1. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1:Objective Response Rate (ORR) as Assessed by investigators | Cycle 2; each cycle is 21 days (up to 42 days) | |
| Part 1:Duration of Response (DOR) as Assessed by investigators | Cycle 2; each cycle is 21 days (up to 42 days) |
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Inclusion Criteria:
Exclusion Criteria:
1、 Cancer-Specific Exclusions
2. Medical history and complications
3. Physical examination and laboratory tests
4. Allergies and adverse drug reactions
5. Subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse.
6. Based on the investigator's judgment, subjects with a history or current evidence of diseases, treatments, or laboratory abnormalities that may affect study results, interfere with study procedures, or are not in the best interests of the subjects, should be excluded.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hosipital | Beijing | Beijing Municipality | 100089 | China | ||
| Henan Cancer Hospital |
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SHR-1210 in combination with Famitinib plus chemotherapy.
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|
| Camrelizumab;Pemetrexed and Carboplatin;Placebo | Drug | Part 2: Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo |
|
|
| Part 1:Progression-free Survival (PFS) as Assessed by investigators | Cycle 2; each cycle is 21 days (up to 42 days) |
| Part 1:Overall Survival (OS). | Up to approximately 60 months |
| Part 2:Overall Survival (OS) | Up to approximately 60 months |
| Part 2:Progression-free Survival (PFS) as Assessed by investigators according to RECIST 1.1. | up to 24 months |
| Part 2:Objective Response Rate (ORR) as Assessed by investigators and BICR according to RECIST 1.1 | up to 24 months |
| Part 2:Duration of Response (DOR) as Assessed by investigators and BICR according to RECIST 1.1 | up to 24 months |
| Part 2:Disease Control Rate(DCR) as Assessed by investigators and BICR according to RECIST 1.1 | up to 24 months |
| Part 2:Number of Participants With Adverse Events and Serious Adverse Event as Assessed by CTCAE v5.0. | up to 24 months |
| Zhengzhou |
| Henan |
| 450003 |
| China |
| Hubei Cancer Hospita | Wuhan | Hubei | 430079 | China |
| Shengjing Hospita of China Medical University | Shenyang | Liaoning | 110022 | China |
| Shanghai Lung Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| West China Hospital,Sichuan University | Chengdu | Sichuan | 610000 | China |
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
| ID | Term |
|---|---|
| D016190 | Carboplatin |
| C584390 | famitinib |
| C000631724 | camrelizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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