CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 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/NCT00796549
NCT00796549Phase 2Completed
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A Phase II Single-arm Trial of BIBW 2992 in EGFR FISH Positive Non-small Cell Lung Cancer Patients

Boehringer Ingelheim·interventional·Posted Nov 24, 2008·Updated Jul 22, 2014

In Brief

A Phase 2 clinical trial evaluating BiBW 2992 for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 70 participants across 13 sites.

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 EGFR FISH positive advanced NSCLC Stage IIIB or IV, selected according to the following scheme: * Forty (40) 1st line patients * Thirty (30) 2nd line patients Patients entered into the trial will be treated and followed until death or lost to follow-up. Additional information will be obtained on the safety profile and PK analysis of BIBW 2992.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 24, 2008
Enrollment StartDec 1, 2008
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.6 years ago

Interventions

BiBW 2992drug

BIBW 2992 in EGFR FISH positive NSCLC patients