A Study of Tarceva (Erlotinib) to Compare Two Different Doses in in Currently Smoking Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (CURRENTS)

Sponsor
Hoffmann-La Roche
Study ID
NCT01183858
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib \[Tarceva\] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

Key Dates

First listed
Aug 18, 2010
Start date
Oct 31, 2010
Status verified
Jul 2015
Primary completion
Oct 31, 2013
Completion
Feb 28, 2014

Study Design

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

Arms

  • Experimental: Erlotinib 150 mg
    Erlotinib 150 mg single daily oral dose until disease progression.
  • Experimental: Erlotinib 300 mg
    Erlotinib 300 mg single daily oral dose until disease progression.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Randomization to Clinical Cutoff: 28 October 2013 (Up to 36.5 Months) ]

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