Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Sponsor
University College, London
Study ID
NCT00275132
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • erlotinib hydrochloride — DRUG
    Tarceva (OSI-774, erlotinib) PO 150 mg daily
  • Matched placebo — DRUG
    Matched placebo PO daily

Study Details

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer.

Key Dates

First listed
Jan 11, 2006
Start date
Apr 30, 2005
Status verified
Dec 2011
Primary completion
Apr 30, 2009
Completion
Apr 30, 2009

Study Design

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

Arms

  • Experimental: Erlotinib
    Tarceva (OSI-774, erlotinib) PO 150mg daily
  • Placebo Comparator: Matched placebo
    Matched placebo PO daily

Primary Outcome Measure

Overall survival [ Time Frame: between date of randomisation and date of death from any cause ]

Related Studies