Carcinoma, Non Small Cell Lung
Conditions
Keywords
NSCLC, Non Squamous cell, Docetaxel, Pemetrexed
Brief 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.
Detailed description
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.
Interventions
DRUGTaxotere
Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
DRUGPemetrexed
Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
Sponsors
Sanofi
Chonnam National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | one year | months after beginning of first cycle chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (months from the beginning of first cycle chemotherapy) | three years | months from the beginning of first cycle chemotherapy |
| Safety Profile | four months | Toxicity using CTCAE version 4.0 |
| Response rate | 6-7th week | Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
Countries
South Korea
Outcome results
None listed