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
- Conditions
- Patients with NSCLC stage IIIb and IV after failure of treatment with erlotinib or gefitinibTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-014563-39-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1100
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 recieved and failed at least one line of cytotoxic chemotherapy including a platinum-based regimen in patients eligible for platinum-based therapy and pemetrexed in pemetrexed eligible patients (unless pemetrexed is not considered a regulatory or clinical standard of care e.g. no label indication, no availability or no coverage by 3rd party payer(s))for advanced or metastatic disease and have progressive disease following at least 12 weeks of treatment with erlotinib or gefitinib
3. Patients pretreated with taxane-based chemotherapy for advanced or metatstatic disease must have experienced stable disease, partial or complete response as best response
Part B.
1. Clinical benefit of 12 weeks duration in Part A
2. Patients must have progressed in Part A according to RECIST 1.1
3. New informed consent must be signed before patients enter Part B of
the trial
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 595
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 374
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%
...
23. Requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2.1.
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 ASCLC 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 progression free survival (PFS) time from the day of randomization until death for patients randomized to either BIBW 2992/paclitaxel combination therapy or comparator chemotherapy.;Timepoint(s) of evaluation of this end point: - Part A: every 6 - 12 weeks<br>- Part B: every 8 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Part A: Progression free survival (PFS) , overall response (OR), safety, Quality of life<br>Part B: Overall survival, overall response, safety, Quality of life;Timepoint(s) of evaluation of this end point: - PFS as well as OR is evaluated every 6 - 12 weeks in Part A and every 8 weeks in Part B<br>- safety is evaluated at every visit.<br>- Overall survival every 30 days<br>- Quality of life: every 4 weeks until first follow up (28 days within the end of trial visit).