CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 208 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.

Search/NCT01310036
NCT01310036Phase 2Completed
CompareCT.gov

An Open-Label Multicenter Study of Erlotinib (Tarceva®) as First Line Therapy Until and Beyond RECIST Progression in NSCLC Patients Who Harbour EGFR Mutations

Hoffmann-La Roche·interventional·Posted Mar 7, 2011·Updated Sep 12, 2018

In Brief

A Phase 2 clinical trial evaluating Erlotinib for Non-Squamous Non-Small Cell Lung Cancer. Completed, enrolled 208 participants across 22 sites in 4 countries.

Detailed Summary

This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Squamous Non-Small Cell Lung Cancer
CountriesHong Kong, South Korea, Taiwan, Thailand
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 7, 2011
Enrollment StartApr 30, 2011
Primary CompletionFeb 14, 2014
Study CompletionDec 30, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.3 years ago

Interventions

Erlotinibdrug

Erlotinib 150 mg was administered orally daily until disease progression or unacceptable toxicity.