NCT04836728

Phase II Study of Chemotherapy and PD-1 Inhibitor Combination With Autologous CIK Cell Immunotherapy to Treat Lung Cancer

A Randomized, Multicenter, Open-label, Phase II Study of Platinum-Containing Chemotherapy and Sintilimab With or Without Autologous Cytokine-induced Killer Cell Immunotherapy in Stage IV Non-Small Cell Lung Cancer Subjects

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This prospective, multi-center, open-label, phase II, randomized controlled trial (CCICC-002b) is to evaluate the efficacy and safety of autologous cytokine-induced killer cell immunotherapy in combination with PD-1 inhibitor and platinum-containing chemotherapy in the first-line treatment of stage IV non-small cell lung cancer (NSCLC).

Conditions

• Non-small Cell Lung Cancer Metastatic
• First-line Treatment

Interventions

Type	Name	Description
BIOLOGICAL	CIK cells injection	CIK cells, more than 1x10\^10 (10 billion ), intravenous infusion, d14, Q3W.
DRUG	Sintilimab Injection	200 mg, intravenous infusion, d1, every 3 weeks
DRUG	Pemetrexed	500 mg/m\^2, intravenous infusion, d1, every 3 weeks
DRUG	Albumin paclitaxel	260 mg/m\^2, intravenous infusion, d1, every 3 weeks
DRUG	Carboplatin	AUC 5, intravenous infusion, d1, every 3 weeks

Timeline

• Start date: 2021-03-31
• Primary completion: 2024-04-30
• Completion: 2026-12-31
• First posted: 2021-04-08
• Last updated: 2025-03-13

Locations

1 site across 1 country: China