TORCH: A Study of Tarceva or Chemotherapy for the Treatment of Advanced Non Small Cell Lung Cancer

Sponsor
National Cancer Institute, Naples
Study ID
NCT00349219
Phase
PHASE3
Status
Completed

Conditions

  • Advanced Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib — DRUG
    erlotinib 150 mg taken orally daily until disease progression
  • cisplatin — DRUG
    cisplatin 80 mg/m2 IV day 1 every 3 weeks given in second-line therapy
  • gemcitabine — DRUG
    gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks, given in second-line
  • cisplatin — DRUG
    cisplatin 80 mg/m2 IV day 1 every 3 weeks for 6 cycles
  • gemcitabine — DRUG
    gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks for 6 cycles
  • erlotinib — DRUG
    erlotinib 150 mg orally taken daily as second line therapy (after disease progression on chemotherapy)

Study Details

The purpose of this study is to compare first-line erlotinib followed at progression by second-line chemotherapy vs. first-line chemotherapy followed at progression by second-line erlotinib in the treatment of Advanced Non Small Cell Lung Cancer (NSCLC).

Key Dates

First listed
Jul 6, 2006
Start date
Dec 31, 2006
Status verified
Jan 2016
Primary completion
Dec 31, 2011
Completion
Jun 30, 2012

Study Design

Enrollment
760 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    erlotinib followed at progression by gemcitabine and cisplatin
  • Active Comparator: 2
    cisplatin and gemcitabine chemotherapy for 6 cycles, followed at progression by erlotinib

Primary Outcome Measure

overall survival [ Time Frame: one year ]

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