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

• Overall Survival (months from the beginning of first cycle chemotherapy) [ Time Frame: three years ] [ Designated as safety issue: No ]
  months from the beginning of first cycle chemotherapy
• Safety Profile [ Time Frame: four months ] [ Designated as safety issue: Yes ]
  Toxicity using CTCAE version 4.0
• Response rate [ Time Frame: 6-7th week ] [ Designated as safety issue: No ]
  Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

• Overall Survival [ Time Frame: three years ] [ Designated as safety issue: No ]
  months from randomization
• Safety Profile [ Time Frame: four months ] [ Designated as safety issue: Yes ]
  Toxicity using CTCAE version 4.0
• Response rate [ Time Frame: 6-7th week ] [ Designated as safety issue: No ]
  Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

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.

Docetaxel is being used in 60mg/m2 3 weekly dosage in Japan and several east Asian institutions. Docetaxel 60mg/m2 and Cisplatin 70 mg/m3 3 weekly regimen will be compared to Pemetrexed 500mg/m2 and Cisplatin 70 mg/m2 3 weekly regimen in first line NSCLC with non-squamous histology.

• Drug: Taxotere
  Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
  Other Names:

  • Taxotere(R)
  • Cisplatin
• Drug: Pemetrexed
  Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
  Other Names:

  • Alimta (R)
  • Cisplatin

• Experimental: Taxotere
  Docetaxel plus Cisplatin
  Intervention: Drug: Taxotere
• Active Comparator: Pemetrexed
  Pemetrexed plus Cisplatin
  Intervention: Drug: Pemetrexed

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)