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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
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
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
Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP)
Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP)
Time frame: 2 years
Median time to RCCEP
Median time to RCCEP
Time frame: 2 years
Median time to RCCEP of level 3 or above
Median time to RCCEP of level 3 or above
Time frame: 2 years
Incidence rate of ≥G3 grade RCCEP
Incidence rate of ≥G3 grade RCCEP
Time frame: 2 years
Overall Response Rate (ORR)
Overall Response Rate (ORR)
Time frame: 2 years
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Time frame: 2 years
Overall Survival(OS)
Overall Survival(OS)
Time frame: 2 years
Treatment-related Adverse Events (TRAE)
Treatment-related Adverse Events (TRAE)
Time frame: 2 years
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