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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer

Conditions
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Carcinoma, Non Small Cell Lung

Intervention / Treatment
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* Drug: Taxotere
* Drug: Pemetrexed


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Taxotere<br>Docetaxel plus Cisplatin | Drug: Taxotere<br>* Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks<br>* Other names: Cisplatin;|
| Active Comparator: Pemetrexed<br>Pemetrexed plus Cisplatin | Drug: Pemetrexed<br>* Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks<br>* Other names: Cisplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | months after beginning of first cycle chemotherapy | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (months from the beginning of first cycle chemotherapy) | months from the beginning of first cycle chemotherapy | three years | 
| Safety Profile | Toxicity using CTCAE version 4.0 | four months | 
| Response rate | Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | 6-7th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Non Squamous cell, Docetaxel, Pemetrexed