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

Chonnam National University

Status and phase

Terminated

Phase 3

Conditions

Carcinoma, Non Small Cell Lung

Treatments

Drug: Taxotere

Drug: Pemetrexed

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01282151

DOCET_L_05478

Details and patient eligibility

About

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.

Full 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.

Enrollment

148 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)