NCT03987867

Study of Autologous CIK Cell Immunotherapy Combination With PD-1 Inhibitor and Chemotherapy in the Advanced NSCLC

Phase I Clinical Study of Autologous CIK Cell Immunotherapy Combination With PD-1 Inhibitor and Chemotherapy in the First-line Treatment of IIIB/IIIC/IV Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This prospective, unicentric, open-labe phase I study is to evaluate the effects of autologous cytokine-induced killer cell immunotherapy combination with PD-1 inhibitor and chemotherapy in the first-line treatment of IIIB/IIIC/IV non-small cell lung cancer.

Detailed description

In the non-squamous NSCLC, patients received sintilimab Injection (PD-1 inhibitor) 200mg, d1; pemetrexed injection 500mg/m2, d1; carboplatin injection AUC 5, d1; CIK cells venous re-transfusion \>=1x10\^10, d14; Q3W, for 4 cycles. Then sintilimab and pemetrexed maintenance treatment for 2 years. In the squamous NSCLC, patients received sintilimab Injection (PD-1 inhibitor) 200mg, d1; liposome paclitaxel injection 135mg/m2, d1; carboplatin injection AUC 5, d1; CIK cells venous re-transfusion \>=1x10\^10, d14; Q3W, for 4 cycles. Then sintilimab maintenance treatment for 2 years.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	CIK cell	CIK cell injection
BIOLOGICAL	Sintilimab Injection	IBI308 injection
DRUG	Pemetrexed	Pemetrexed injection
DRUG	Liposome paclitaxel	Liposome paclitaxel injection
DRUG	Carboplatin	Carboplatin injection

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-06-17
• Last updated: 2020-07-07

Locations

1 site across 1 country: China