CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 688 enrolled
Drug / intervention
erlotinib [Tarceva]drug
Likely dose
erlotinib [Tarceva] 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.

Search/NCT01250119
NCT01250119Phase 2Completed

Assess the Incidence of Mutations in the Tyrosine Kinase Domain of the Endothelial Growth Factor Receptor in UK Patients With Newly Diagnosed Metastatic or Recurrent Non-small Cell Lung Cancer and to Investigate the Quality of Life of These Patients Undergoing First-line Therapy With Erlotinib.

Hoffmann-La Roche·interventional·Posted Nov 30, 2010·Updated Mar 14, 2016

In Brief

A Phase 2 clinical trial evaluating erlotinib [Tarceva] for Non-Squamous Non-Small Cell Lung Cancer. Completed, enrolled 688 participants across 22 sites.

Detailed Summary

This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm study to evaluate progression-free survival and quality of life with first-line Tarceva (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily. Anticipated time on study treatment is until progressive disease or unacceptable toxicity occurs. Patients with negative EGFR mutation results will be offered treatment as per the centre's standard of care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2010
Enrollment StartMar 1, 2011
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 15.6 years ago

Interventions

erlotinib [Tarceva]drug

150 mg daily, orally