A Study to Assess Biomarkers Impact on Participants Response to Erlotinib Treatment for First-line Non-Small Cell Lung Cancer With Endothelial Growth Factor Receptor (EGFR) Activating Mutations
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT01153984
- Phase
- PHASE2
- Status
- Completed
Conditions
- Carcinoma，Non-Small-Cell Lung
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Erlotinib — DRUGErlotinib 150 mg oral doses will be administered daily.
Study Details
This open-label, single-arm, multi-center study will evaluate the progression-free survival in participants with histologically documented, advanced and/or metastatic chemotherapy naive, non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) positive mutations and receiving erlotinib treatment. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
Key Dates
- First listed
- Jun 30, 2010
- Start date
- Jun 30, 2011
- Status verified
- Feb 2017
- Primary completion
- Jul 31, 2015
- Completion
- Jul 31, 2015
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ErlotinibParticipants will receive 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
Primary Outcome Measure
Progression-Free Survival (PFS), as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [ Time Frame: Baseline up to approximately 4 years ]