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

Tracking Information
First Submitted Date ICMJE	February 12, 2012
First Posted Date ICMJE	February 15, 2012
Last Update Posted Date	December 9, 2013
Study Start Date ICMJE	August 2011
Estimated Primary Completion Date	December 2017 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 14, 2012)	the relapse rate [ Time Frame: 30 months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01533727 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)
Official Title ICMJE	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
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Non-small Cell Lung Cancer
Intervention ICMJE	Drug: Autologous 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; Drug: chemotherapy alone vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w;
Study Arms	Experimental: Group A Autologous CIK Transfusion plus Chemotherapy Intervention: Drug: Autologous CIK Transfusion plus Chemotherapy; Active Comparator: Group B chemotherapy alone Intervention: Drug: chemotherapy alone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Withdrawn
Actual Enrollment ICMJE; (submitted: December 5, 2013)	0
Original Estimated Enrollment ICMJE; (submitted: February 14, 2012)	222
Estimated Study Completion Date	December 2020
Estimated Primary Completion Date	December 2017 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Stage IB-IIIA post-surgery NSCLC patients with histologically confirmed.; with an Eastern CooperativeOncology Group performance status of 0 or 1,; at least 18 years of age; adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula; patients had fully recovered from its acute effects. Exclusion Criteria: HIV positive; autoimmune disease; immune deficiency disorder; organ transplantation; received high dose glucocorticoid or other immune depressant within 4 weeks; active clinically serious infections (> grade 2 NCI-CTC version 3.0); life threatening medical condition
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 70 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	China
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01533727
Other Study ID Numbers ICMJE	2010014
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Li Zhang, Sun Yat-sen University
Study Sponsor ICMJE	Sun Yat-sen University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Li Zhang, MD Sun Yat-sen University
PRS Account	Sun Yat-sen University
Verification Date	February 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP