drugset / Trial / NCT01533727

CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)

NCT01533727

Phase 2 Withdrawn Sun Yat-sen University
RandomizedParallel-groupOpen-labelTreatment

Summary

Non - small cell lung cancer ( NSCLC ) accounts for more than 80% of lung cancer. The main treatment for early stage patients is surgical resection, but about 30% -70% patients will relapse. Postoperative chemotherapy is the major systemic treatment for surgical resection NSCLC patients. However, data show only 5-10% improvement in overall survival with systemic adjuvant chemotherapy. It is necessary to further improve the survival time of patients with lung cancer. Biological treatment is becoming a new treatment modality for Cancer following with surgery, radiotherapy and chemotherapy, and has been confirmed as an effective adjuvant treatment in comprehensive cancer treatment. Cytokine induced killer cells ( CIK) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum is most widely used and thought to be the first choice for the new generation of anti-tumor adoptive immunotherapy. This Phase II study is investigating the efficacy of Autologous Cytokine-Induced Killer Cell Transfusion plus Chemotherapy as adjuvant therapy for stage IB-IIIA NSCLC.

Timeline

Start
2011-08
Primary completion
2017-12
Completion
2020-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CIK cells Cell therapy
Background Carboplatin Small molecule
Background DDP Unknown 75 mg/m2
Background Pemetrexed Small molecule 500 mg/m2
Background Vinorelbine Small molecule 25 mg/m2
Background Vinorelbine Small molecule 30 mg/m2