LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||LUX Lung 2 A Phase II Single-arm Trial of BIBW 2992 in Non-small Cell Lung Cancer Patients With EGFR Activating Mutations|
- Objective Response (OR) [ Time Frame: Baseline to data cut-off for independent review (12 Jan 2011) ] [ Designated as safety issue: No ]Percentage of participants with best objective response (OR): confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.0) by independent review.
- Progression-free Survival (PFS) [ Time Frame: From first dose of study medication until progression, death, start of another anti-cancer therapy or last date of tumor imaging for ongoing patients. ] [ Designated as safety issue: No ]PFS was defined as the duration of time from the start of treatment until the day of objective tumor progression was confirmed by tumor imaging (PD according to RECIST 1.0) or death by independent review.
- Overall Survival (OS) [ Time Frame: From first dose of study medication to data cut-off ] [ Designated as safety issue: No ]OS was defined as the duration of time from start of treatment to time of death.
- Clinical Benefit (CB) [ Time Frame: From first dose of study medication to data cut-off ] [ Designated as safety issue: No ]Clinical benefit was evaluated by assessment of complete response (CR), partial response (PR) and stable disease (SD) according to RECIST 1.0 by independent review.
- Duration of OR [ Time Frame: From first dose of study medication to data cut-off ] [ Designated as safety issue: No ]Duration of objective response (OR) was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented (per independent review).
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||March 2014|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: BIBW 2992
Patients start continuous once daily oral treatment of BIBW 2992 at high dose, until progression or undue Adverse Events (AEs) develop. Patients can be dose-reduced up to two times if needed after temporary discontinuation of treatment due to drug-related AEs. After protocol amendment 2 (17 Dec 2008), the starting dose of BIBW 2992 was reduced to a medium dose, with 2 possible dose reductions if needed after discontinuation due to drug-related AEs.
Drug: BIBW 2992
This is an open label study. Patients are treated with BIBW 2992 until disease progression or undue AEs
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525148
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|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|