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

A Phase 2,Open-label Study of Autologous Cytokine-Induced Killer Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01533727

Enrollment

Registered

2012-02-15

Start date

2011-08-31

Completion date

2020-12-31

Last updated

2013-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Cytokine-Induced Killer Cell, NSCLC, adjuvant therapy

Brief 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.

Interventions

DRUGAutologous CIK Transfusion plus Chemotherapy

vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w; CIK infusion D14 q3w

DRUGchemotherapy alone

vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w;

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Stage IB-IIIA post-surgery NSCLC patients with histologically confirmed. 2. with an Eastern CooperativeOncology Group performance status of 0 or 1, 3. at least 18 years of age 4. adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula 5. patients had fully recovered from its acute effects.

Exclusion criteria

1. HIV positive 2. autoimmune disease 3. immune deficiency disorder 4. organ transplantation 5. received high dose glucocorticoid or other immune depressant within 4 weeks 6. active clinically serious infections (\> grade 2 NCI-CTC version 3.0) 7. life threatening medical condition

Design outcomes

Primary

Measure	Time frame
the relapse rate	30 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026