NCT02651441

D-CIK Combined With Chemotherapy for Non-Small Cell Lung Cancer(NSCLC)

Randomized, Controlled Study of the Safety and Efficacy of D-CIK Immune Cell Combined With Chemotherapy for Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of chemotherapy combined with dendritic activated cytokine-induced killer cell (D-CIK) for non-small cell lung cancer (NSCLC).

Detailed description

60 patients with stage Ⅲb～Ⅳ NSCLC will be randomly divided into group A（receive D-CIK treatment and chemotherapy) or group B（just receive chemotherapy),and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of D-CIK treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks).Patients in group B will receive only 4 cycles chemotherapy（every 2 weeks).

Conditions

• Lung Cancer
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.
DRUG	Cisplatin	Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.
BIOLOGICAL	D-CIK	8×10\^9 D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-05-01
• Completion: 2019-08-01
• First posted: 2016-01-11
• Last updated: 2016-05-24

Locations

1 site across 1 country: China