CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 364 enrolled
Drug / intervention
Gemcitabine+Cisplatin +1 moredrug
Likely dose
BIBW 2992 40 mgfrom 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/NCT01121393
NCT01121393Phase 3Completed
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LUX-Lung 6: A Randomized, 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 May 12, 2010·Updated Dec 14, 2018

In Brief

A Phase 3 clinical trial evaluating Gemcitabine+Cisplatin and BIBW 2992 for Carcinoma, Non-Small-Cell Lung and Adenocarcinoma. Completed, enrolled 364 participants across 36 sites in 3 countries.

Detailed Summary

To investigate the efficacy and safety of BIBW 2992 compared to standard first-line chemotherapy in patients with stage IIIB or IV adenocarcinoma of the lung harbouring an EGFR activating mutation

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung, Adenocarcinoma
CountriesChina, South Korea, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 12, 2010
Enrollment StartApr 19, 2010
Primary CompletionNov 23, 2017
Study CompletionNov 26, 2017
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 16.1 years ago

Interventions

Gemcitabine+Cisplatindrug

Gemcitabine d1,8, Cisplatin d1, 21 days as a course, up to 6 courses.

BIBW 2992drug

starting dose is 40 mg, in the event of no or minimal drug-related adverse events after one course, the dose will be increased to 50mg. in the event of certain drug related Adverse Event (AE), dose reduction will be increments of 10 mg, with the lowest dose being 20mg.