NCT06276933

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

A Prospective, Multicenter, Double-blind, Randomized Controlled Study of Camrelizumab Combined With Chemotherapy ± Thalidomide in First-line Treatment of Patients With Advanced NSCLC

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Tongji University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Lung Cancer
• Camrelizumab

Interventions

Type	Name	Description
DRUG	Camrelizumab + chemotherapy+Thalidomide	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 + chemotherapy+placebo	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

Timeline

• Start date: 2024-02-22
• Primary completion: 2025-11-22
• Completion: 2026-11-22
• First posted: 2024-02-26
• Last updated: 2024-02-26