A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations

Sponsor
Hoffmann-La Roche
Study ID
NCT01287754
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This single arm, open-label study will assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.

Key Dates

First listed
Feb 1, 2011
Start date
Oct 31, 2011
Status verified
May 2015
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm

Primary Outcome Measure

Progression-Free Survival (PFS) Among Erlotinib-Treated Participants With the EGFR Mutation [ Time Frame: Per standard of care (every 3 months) until discontinuation for up to approximately 2 years ]

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