Carcinoma, Non Small Cell Lung | TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
Carcinoma, Non Small Cell Lung research study
What is the primary objective of this study?
This study is: - A multicenter, prospective, randomized, phase 3 trial. - To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer. - 276 patients will be recruited.
Who is eligible to participate?
Inclusion Criteria: - Age >= 18 years old - ECOG performance status 0-2 - Non-squamous cell type non-small cell lung cancer (NSCLC) - Stage IV, Stage IIIB cannot be treated with curative intent or Relapsed after surgery or radiation therapy - No prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation treatment. The last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed. - No prior immunotherapy, biologic therapy - Measurable lesion with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - Hemoglobin >=9.0g/dl, Platelet >=100,000/uL, neutrophil >=1,500 /uL Creatinine <=1.5 x upper normal limit or creatinine clearance >=60 mL/min Bilirubin <=1.5 x upper normal limit, Transaminases <=2 x upper normal limit Alkaline phosphatase <=2 x upper normal limit - Written informed consent Exclusion Criteria: - Pregnancy, Lactating woman - Woman in child bearing age who refuses to do pregnancy test - Moderate or greater than grade 1 motor or sensory neurotoxicity - Hypersensitivity to taxane - Comorbidity or poor medical conditions - Other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in situ) - Concurrent treatment with other investigational drugs within 30 days before randomization - Active treatment with other anticancer chemotherapy - EGFR mutation (exon 19 deletion, L858R, L861Q, G719A/C/S)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Carcinoma, Non Small Cell Lung
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:TaxotereDocetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
Drug:PemetrexedPemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
TaxotereDocetaxel plus Cisplatin
PemetrexedPemetrexed plus Cisplatin
Start Date: July 2011
Completed Date: December 2014
Phase: Phase 3
Primary Outcome: Progression Free Survival
Secondary Outcome: Overall Survival (months from the beginning of first cycle chemotherapy)
Study sponsors, principal investigator, and references
Principal Investigator: Young-Chul Kim, MD, PhD
Lead Sponsor: Chonnam National University Hospital