CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
BIBW 2992drug
Likely dose
BIBW 2992 40mgfrom 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/NCT01542437
NCT01542437Phase 2Completed

Treatment With BIBW 2992, Irreversible Inhibitor of EGFR and HER-2 in Non Small Cell Lung Cancer in Advanced Stage, Which Have Progressed to Chemotherapy. Analysis of Mutations in EGFR and Number of Copies of HER-2

Instituto Nacional de Cancerologia de Mexico·interventional·Posted Mar 2, 2012·Updated Feb 6, 2024

In Brief

A Phase 2 clinical trial evaluating BIBW 2992 for Non-Small Cell Lung Cancer and 2 related conditions. Completed, enrolled 66 participants across 1 site.

Detailed Summary

Patients with stage IIIB and IV lung adenocarcinoma and progression to first-line chemotherapy were enrolled to receive afatinib 40 mg/day. Mutational EGFR and HER-2 status were assessed by RT-PCR. HER2 amplification was evaluated by FISH. Plasma HGF levels were measured by ELISA before and 2 months (mo) after the start of treatment. We assessed changes in serum HGF levels and their association with objective response rate (ORR), PFS and overall survival (OS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2012
Enrollment StartJan 1, 2012
Primary CompletionJun 1, 2014
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.3 years ago

Interventions

BIBW 2992drug

All patients will receive: BIBW 2992 40mg every 24 hours orally, where a cycle corresponds to complete this treatment for 28 days; option 30mg/day dose reductions, according to established criteria. Not to be compared with any other drug.