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

Phase 2 Active not recruiting 156 enrolled Tianjin Medical University Cancer Institute and Hospital

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start: 2021-03-31
Primary completion: 2024-04-30
Completion: 2026-12-31

Publications

Zhou J, Bie H, You Y, Li J, Liu J, Li S, Huang H, Zhou L, Hui Z, Zhang W, Meng Y, Lin H, Zheng L, Qi Y, Ji Z, Yu W, Wang M, Ren X, Yan C. Circulating CD28-KLRG1+CD8+ T cells involve in systemic and local immunity that predicts chemoimmunotherapy outcomes in advanced NSCLC. J Transl Med. 2026 Jun 22. doi: 10.1186/s12967-026-08484-5. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CIK cells	Cell therapy	1e+10 cells	Intravenous
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Paclitaxel	Small molecule	260 mg/m2	Intravenous
Background	Pemetrexed	Small molecule	500 mg/m2	Intravenous
Background	Sintilimab	Monoclonal antibody	200 mg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications