TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chonnam National University Hospital
• Collaborator: Sanofi
• Treatments: Cisplatin; Docetaxel; Pemetrexed

Criteria

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)