CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 345 enrolled
Drug / intervention
Pemetrexed +2 moredrug
Likely dose
Not stated in 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/NCT00949650
NCT00949650Phase 3Completed
CompareCT.gov

A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation

Boehringer Ingelheim·interventional·Posted Jul 30, 2009·Updated Apr 6, 2018

In Brief

A Phase 3 clinical trial evaluating Pemetrexed, BIBW 2992, and 1 other intervention for Carcinoma, Non-Small-Cell Lung and Adenocarcinoma. Completed, enrolled 345 participants across 133 sites in 25 countries.

Detailed Summary

This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung, Adenocarcinoma
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, Malaysia, Peru, Philippines, Romania, Russia, South Korea, Taiwan, Thailand, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 30, 2009
Enrollment StartAug 14, 2009
Primary CompletionFeb 9, 2012
Study CompletionMar 16, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.9 years ago

Interventions

Pemetrexeddrug

Pemetrexed IV given once every 3 weeks for up to 6 cycles

BIBW 2992drug

BIBW 2992 once daily until progression

Cisplatindrug

Cisplatin IV given once every 3 weeks for up to 6 cycles