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

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

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.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Non Small Cell Lung
• Intervention / Treatment: Drug: Taxotere; Drug: Pemetrexed

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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Anyang, Korea, Republic of
    • Hallym University Medical Center
  • Cheonan, Korea, Republic of, 330-715
    • Dankook University Hospital
  • Daegu, Korea, Republic of, 700-712
    • Keimyung University Dongsan Center
  • Daegu, Korea, Republic of
    • Yeungnam Univeristy Hospital
  • Gwangju, Korea, Republic of
    • Chosun University Hospital
  • Iksan, Korea, Republic of
    • Wonkwang University Hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Pusan, Korea, Republic of, 602-739
    • Pusan National University Hospital
  • Pusan, Korea, Republic of
    • Kosin University Gospel Hospital
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of
    • Korea Cancer Center Hospital
  • Seoul, Korea, Republic of
    • Korea University Medical Center
  • Wonju, Korea, Republic of
    • Wonju Christian Hospital
  • Jeonnam
    • Hwasun, Jeonnam, Korea, Republic of, 519-709
      • Chonnam National University Hwasun Hospital
  • Kyungpook
    • Daegu, Kyungpook, Korea, Republic of
      • Kyungpook National University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Taxotere; Docetaxel plus Cisplatin	Drug: Taxotere; Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks; Other Names: Cisplatin; Taxotere(R)
Active Comparator: Pemetrexed; Pemetrexed plus Cisplatin	Drug: Pemetrexed; Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks; Other Names: Cisplatin; Alimta (R)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chonnam National University Hospital
• Collaborators: Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: January 21, 2011
• First Posted (Estimate): January 24, 2011

Study Record Updates

• Last Update Posted (Estimate): July 14, 2015
• Last Update Submitted That Met QC Criteria: July 13, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Docetaxel; NSCLC; Pemetrexed; Non Squamous cell
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Folic Acid Antagonists; Docetaxel; Cisplatin; Pemetrexed
• Other Study ID Numbers: DOCET_L_05478