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| Name | Class |
|---|---|
| Shanghai Pulmonary Hospital, Shanghai, China | OTHER |
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To explore and evaluate the safety and efficacy of camrelizumab combined with chemotherapy ± thalidomide in first-line treatment of advanced non-small cell lung cancer patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab+Chemotherapy+Thalidomide | Experimental |
| |
| Camrelizumab + chemotherapy+placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab + chemotherapy+Thalidomide | Drug | Camrelizumab + chemotherapy+Thalidomide Drug: Camrelizumab Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle,until progression or unacceptable toxicity Other Name: SHR-1210 Drug: Thalidomide Thalidomide 100mg,po qd; Other Name: Thalidomide Drug: Chemotherapy Platinum-based chemotherapy: Non-small cell lung cancer (non-squamous cell carcinoma): pemetrexed plus carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles,pemetrexed every three weeks (Q3W) maintenance for the remainder of the study or until documented PD; Non-small cell lung cancer (squamous cell carcinoma) : paclitaxel/albumin-bound paclitaxel + carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles. Other Name: Platinum-based chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP) | Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Median time to RCCEP | Median time to RCCEP | 2 years |
| Median time to RCCEP of level 3 or above | Median time to RCCEP of level 3 or above |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anwen Xiong, MD | Contact | 18221013620 | anwenxiong@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| Anwen Xiong, MD | Department of Oncology, Shanghai pulmonary hospital Shanghai, China, 200433 | Study Director |
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|
| Camrelizumab + chemotherapy+placebo | Drug | Drug: Camrelizumab Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle,until progression or unacceptable toxicity Other Name: SHR-1210 Drug: placebo 100mg placebo 100mg,po qd; Drug: Chemotherapy Platinum-based chemotherapy: Non-small cell lung cancer (non-squamous cell carcinoma): pemetrexed plus carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles,pemetrexed every three weeks (Q3W) maintenance for the remainder of the study or until documented PD; Non-small cell lung cancer (squamous cell carcinoma) : paclitaxel/albumin-bound paclitaxel + carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles. Other Name: Platinum-based chemotherapy |
|
| 2 years |
| Incidence rate of ≥G3 grade RCCEP | Incidence rate of ≥G3 grade RCCEP | 2 years |
| Overall Response Rate (ORR) | Overall Response Rate (ORR) | 2 years |
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) | 2 years |
| Overall Survival(OS) | Overall Survival(OS) | 2 years |
| Treatment-related Adverse Events (TRAE) | Treatment-related Adverse Events (TRAE) | 2 years |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| 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 |
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