At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 256 enrolled
Drug / intervention
erlotinib +1 moredrug
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.
A Randomized, Controlled Phase III Trial to Evaluate the Efficacy of Elortinib vs Gefitinib in Advanced Non-small-cell Lung Cancer With EGFR Exon 19 or 21 Mutations
In Brief
A Phase 3 clinical trial evaluating erlotinib and gefitinib for Thoracic Neoplasms. Completed, enrolled 256 participants across 1 site.
Detailed Summary
This is a randomized controlled trial to compare efficacy and safety between erlotinib and gefitinib in advanced NSCLC harboring EGFR exon 19 or 21 mutations.Eligible patients were randomized to receive erlotinib or gefitinib in any line settings.The primary endpoint was progression-free survival (PFS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThoracic Neoplasms
CountriesChina
CollaboratorsGuangdong Provincial People's Hospital
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedDec 2009
Primary CompletionJun 2015
TodayJul 2026
First PostedDec 2, 2009
Enrollment StartJul 1, 2009
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 16.6 years ago
Interventions
erlotinibdrug
study arm.erlotinib 150 mg oral till disease progression
gefitinibdrug
study arm.gefitinib 250 mg oral till disease progression