A Study of Tarceva (Erlotinib) in Patients With Locally Advanced, Metastatic or Recurrent Non-Small Cell Cancer Who Present Epidermal Growth Factor Receptor Mutations

Sponsor
Hoffmann-La Roche
Study ID
NCT01372384
Phase
PHASE2
Status
Completed

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

Study Details

This open-label study will assess the efficacy and safety of Tarceva (Erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Key Dates

First listed
Jun 13, 2011
Start date
Jan 31, 2012
Status verified
Jan 2016
Primary completion
Jan 31, 2014
Completion
Jan 31, 2014

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm

Primary Outcome Measure

Progression-free Survival (Tumour Assessments According to RECIST Criteria) [ Time Frame: Until participants had disease progression, unacceptable toxicity or died; approximately 24 months. ]

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