CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,154 enrolled
Drug / intervention
Investigator´s choice of chemotherapy +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/NCT01085136
NCT01085136Phase 3Completed
CompareCT.gov

Phase III Randomized Trial of BIBW 2992 Plus Weekly Paclitaxel Versus Investigator's Choice of Chemotherapy Following BIBW 2992 Monotherapy in Non-small Cell Lung Cancer Patients Failing Previous Erlotinib or Gefitinib Treatment (LUX Lung 5)

Boehringer Ingelheim·interventional·Posted Mar 11, 2010·Updated Apr 4, 2017

In Brief

A Phase 3 clinical trial evaluating Investigator´s choice of chemotherapy and BIBW 2992 for Carcinoma, Non-Small-Cell Lung. Completed, enrolled 1,154 participants across 97 sites in 23 countries.

Detailed Summary

The primary objective of this randomized, open-label, active-controlled, multi-center trial is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment. Patients enrolled into the trial will be treated and followed until death or lost to follow-up. Additional information on the health-related quality of life (HRQOL) will be collected.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Non-Small-Cell Lung
CountriesArgentina, Australia, Austria, Belgium, Brazil, China, Finland, France, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Peru, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2010
Enrollment StartFeb 1, 2010
Primary CompletionOct 1, 2013
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 16.3 years ago

Interventions

Investigator´s choice of chemotherapydrug

BIBW 2992 in a medium dose in combination with Paclitaxel to explore safety and efficacy versus investigator´s choice of chemotherapy

BIBW 2992drug

BIBW 2992 will be given in a medium dose in combination with Paclitaxel to explore safety and efficacy versus investigator´s choice of chemotherapy