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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

Phase 3
18 Years
Open (Enrolling)
Carcinoma, Non Small Cell Lung

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Trial Information

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

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.

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

- 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

- Concurrent treatment with other investigational drugs within 30 days before

- Active treatment with other anticancer chemotherapy

- EGFR mutation (exon 19 deletion, L858R, L861Q, G719A/C/S)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

months after beginning of first cycle chemotherapy

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Young-Chul Kim, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Chonnam National University Hospital


Korea: Institutional Review Board

Study ID:




Start Date:

July 2011

Completion Date:

June 2014

Related Keywords:

  • Carcinoma, Non Small Cell Lung
  • Non Squamous cell
  • Docetaxel
  • Pemetrexed
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms