BIBW2992 (Afatinib) in Advanced (EGFR-FISH +) NSCLC (Non Small Cell Lung Cancer) Patients
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 Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Single-arm Trial of BIBW 2992 in EGFR FISH Positive Non-small Cell Lung Cancer Patients|
- Percentage of Participants With Best Objective Response [ Time Frame: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12. ]Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.
- Number of Participants With Objective Response (OR) Categorized by Time [ Time Frame: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12. ]Cumulative number of participants with objective response by time points with responders.
- Duration of Confirmed Objective Response (OR) [ Time Frame: Tumour assessments were performed at baseline (tumour assessment obtained within 4 weeks prior to beginning of treatment), week 8, and every 8 weeks until last response assessment 28NOV12. ]Duration of confirmed Objective Response is measured from the time of first Objective Response (OR) to the time of progression or death (or date of censoring for progression free survival).
- Percentage of Participants With Disease Control (DC) [ Time Frame: Every 8 weeks until last response assessment 28NOV12 ]Percentage of participants with Objective response (OR) or stable disease (SD) as determined by RECIST version 1.0.
- Duration of Confirmed Disease Control [ Time Frame: Every 8 weeks until last response assessment 28NOV12 ]Duration of Disease Control is measured from the time of first Objective Response to the time of progression or death (or date of censoring for progression free survival) or respectively for SD as the time from date of randomization to date that disease progression.
- Progression Free Survival (PFS) Time [ Time Frame: Every 8 weeks until last response assessment 28NOV12 ]Progression Free Survival time defined as time from the start of treatment to the earliest of progression (RECIST), clinical progression (investigator), start of new anti-cancer treatment or death.
- Overall Survival (OS) Time [ Time Frame: Baseline until last vital status assessment 17JUN13 ]Overall survival time is defined as time from the date of start of treatment to the date of death.
- Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 15 (Cpre,ss,15) [ Time Frame: Day 15 ]Cpre,ss,15 represents the pre-dose concentration of afatinib in plasma at steady state on day 15.
- Number of Participants With Clinical Relevant Finding in Gastrointestinal and Skin Disorder [ Time Frame: First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks ]The safety of patients was overall assessed in terms of adverse events (AEs), graded according to US NCI CTCAE version 3.0 [R04-0474], including skin reactions and gastrointestinal AEs.
- Number of Participants With Clinical Relevant Findings in Laboratory Safety Parameters, Vital Signs and Left Ventricular Ejection Fraction [ Time Frame: First administration of trial medication until 28 days after last administration of trial medication, up until 194 weeks ]
Number of participants with clinical relevant findings in Laboratory safety parameters, vital signs and Left ventricular ejection fraction . Relevant findings or worsenings of baseline conditions were reported as Adverse Events.
There were no clinically relevant finding reported for Vital signs and Left ventricular ejection fraction (LVEF).
- Assessment of Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: End Of Treatment, up until 190 weeks ]
Performance status assessed according to Eastern Cooperative Oncology Group (ECOG) performance status based on categories defined below :
0 : Fully active, able to carry on all pre-disease performance without restriction.
- : Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- : Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
- : Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.
- : Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
- : Dead.
Note: The ECOG scores presented are assessed at the end of treatment not at baseline, hence the patients having ECOGs>2 are included.
|Study Start Date:||December 2008|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: BIBW 2992
BIBW 2992 in EGFR FISH positive NSCLC patients
Drug: BiBW 2992
BIBW 2992 in EGFR FISH positive NSCLC patients
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796549
|1200.40.39011 Boehringer Ingelheim Investigational Site|
|1200.40.39007 Boehringer Ingelheim Investigational Site|
|Aviano (PN), Italy|
|1200.40.39013 Boehringer Ingelheim Investigational Site|
|Faenza (RA), Italy|
|1200.40.39003 Boehringer Ingelheim Investigational Site|
|1200.40.39010 Boehringer Ingelheim Investigational Site|
|1200.40.39012 Boehringer Ingelheim Investigational Site|
|Lugo (RA), Italy|
|1200.40.39008 Boehringer Ingelheim Investigational Site|
|1200.40.39005 Boehringer Ingelheim Investigational Site|
|Monza (MI), Italy|
|1200.40.39006 Boehringer Ingelheim Investigational Site|
|1200.40.39002 Boehringer Ingelheim Investigational Site|
|1200.40.39004 Boehringer Ingelheim Investigational Site|
|1200.40.39009 Boehringer Ingelheim Investigational Site|
|1200.40.39001 Boehringer Ingelheim Investigational Site|
|Rozzano (MI), Italy|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|