A Study of Camrelizumab Combined With Chemotherapy ± Thalidomide in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Sponsor
Tongji University
Study ID
NCT06276933
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
  • 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

Study Details

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

Key Dates

Start date
Feb 22, 2024
Status verified
Feb 2024
Primary completion
Nov 22, 2025
Completion
Nov 22, 2026

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab+Chemotherapy+Thalidomide
  • Active Comparator: Camrelizumab + chemotherapy+placebo

Primary Outcome Measure

Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP) [ Time Frame: 2 years ]

Central Contacts

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