CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 129 enrolled
Drug / intervention
BIBW 2992drug
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/NCT00525148
NCT00525148Phase 2Completed
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LUX Lung 2 A Phase II Single-arm Trial of BIBW 2992 in Non-small Cell Lung Cancer Patients With EGFR Activating Mutations

Boehringer Ingelheim·interventional·Posted Sep 5, 2007·Updated Sep 16, 2016

In Brief

A Phase 2 clinical trial evaluating BIBW 2992 for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 129 participants across 30 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 RECIST criteria in patients with advanced NSCLC Stage IIIB or IV whose tumors harbor activating mutations within exon 18 to exon 21 of the EGFR receptor. Patients progressing or relapsing after one prior cytotoxic chemotherapy regimen as well as chemotherapy naïve patients (only in stage 2) will be allowed to enter into the trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesTaiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2007
Enrollment StartAug 1, 2007
Primary CompletionFeb 1, 2010
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.8 years ago

Interventions

BIBW 2992drug

This is an open label study. Patients are treated with BIBW 2992 until disease progression or undue AEs