CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
BIBW2992 +1 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/NCT00730925
NCT00730925Phase 2Completed
CompareCT.gov

A Phase II Single-arm Trial of BIBW 2992 in Demographically and Genotypically Selected NSCLC

Boehringer Ingelheim·interventional·Posted Aug 8, 2008·Updated Mar 26, 2014

In Brief

A Phase 2 clinical trial evaluating BIBW2992 and BIBW2992 + paclitaxel for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 41 participants across 7 sites in 2 countries.

Detailed Summary

The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria, in patients with advanced NSCLC Stage IIIB or IV whose tumours harbour activating mutations within exon 18 to exon 21 of the EGFR receptor, in patients with mutations in the HER2/neu receptor and in patients with EGFR FISH positive tumours with no EGFR mutations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesBelgium, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 8, 2008
Enrollment StartJun 1, 2008
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.9 years ago

Interventions

BIBW2992drug

tablet BIBW high dose

BIBW2992 + paclitaxeldrug

tablet BIBW 2992 in combination with i.v. paclitaxel 3 weekly