Phase III randomized trial of BIBW 2992 plus weekly paclitaxel versusInvestigator’s choice of chemotherapy following BIBW 2992monotherapy in non-small cell lung cancer patients failing previouserlotinib or gefitinib treatment - LuxLung 5
- Conditions
- Patients with NSCLC (non-small cell lung cancer) stage IIIb and IV experiencing a benefit from BIBW 2992 monotherapy after failing at least one line of chemotherapy and prior treatment with erlotinib or gefitinib.
- Registration Number
- EUCTR2009-014563-39-FR
- Lead Sponsor
- Boehringer Ingelheim France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
Part A:
1. Patients with pathologically confirmed diagnosis of NSCLC Stage IIIb and IV who failed treatment with erlotinib or gefitinib
2. Patients should have received and failed at least one line of cytotoxic chemotherapy for advanced or metastatic disease; however, the following patients are exempt:
a) patients with known EGFR mutation shown by accepted methods after therapy with reversible TKIs are eligible without prior chemotherapy
b) patients with clinical benefit (disease stabilisation or response) to erlotinib or gefitinib >= 6 months are eligible without prior chemotherapy
Part B:
1. Clinical benefit of greater than 12 weeks duration in Part A
2. Patients must have progressed in Part A according to RECIST 1.1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Previous treatment with BIBW 2992
2. Chemo-, hormone or immunotherapya within the past 4 weeks
3. Active brain metastases
4. Patients who have any other life-threatening illness or organ system dysfunction
5. Other malignancies diagnosed requiring therapy
6. History or presence of clinically relevant cardiovascularabnormalities
7. Cardiac left ventricular function with resting ejection fraction of less than 50%
...
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective is to determine the efficacy of BIBW 2992 plus weekly paclitaxel compared to Investigator`s choice of chemotherapy alone in patients with NSCLC stage IIIb or IV progressing after a benefit from BIBW 2992 montherapy.;Secondary Objective: Gaining information on safety and health-related quality of life separately for Part A and B;Primary end point(s): The primary endpoint is the overall survival (OS) time from the day of randomization until death for patients randomized to either BIBW 2992/paclitaxel combination therapy or comparator chemotherapy.
- Secondary Outcome Measures
Name Time Method