Patients with NSCLC stage IIIb and IV after failure of treatment with erlotinib or gefitinib
Conditions
Interventions
Trade Name: GIOTRIF 50 mg film-coated tablets
Product Code: BIBW 2992
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: afatinib
Current Sponsor code: BIBW 2992
Concentration unit: mg milli
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - Part B: every 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A: Progression free survival (PFS) , overall response (OR), safety, Quality of life 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 - safety is evaluated at every visit. - Overall survival every 30 days - Quality of life: every 4 weeks until first follow up (28 days within the end of trial visit). | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, China, Finland, France, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Peru, Poland, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom
Contacts
Public ContactQRPE PSC CT Information Disclosure
BoehringerIngelheim Pharma GmbH and Co. KG
Outcome results
None listed