At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 23 enrolled
Drug / intervention
Erlotinibdrug
Likely dose
Erlotinib 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Biomarkers Impact on the Response to Treatment With Erlotinib in First Line Non-small Cell Lung Cancer With EGFR Activating Mutations - BIOTEC
In Brief
A Phase 2 clinical trial evaluating Erlotinib for Carcinoma，Non-Small-Cell Lung. Completed, enrolled 23 participants across 9 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma，Non-Small-Cell Lung
CountriesRomania
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartJun 2011
Primary CompletionJul 2015
TodayJul 2026
First PostedJun 30, 2010
Enrollment StartJun 1, 2011
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 16.0 years ago
Interventions
Erlotinibdrug
Erlotinib 150 mg oral doses will be administered daily.