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

C

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

148 participants in 2 patient groups

Taxotere
Experimental group
Description:
Docetaxel plus Cisplatin
Treatment:
Drug: Taxotere
Pemetrexed
Active Comparator group
Description:
Pemetrexed plus Cisplatin
Treatment:
Drug: Pemetrexed

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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