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 gefitinib; MedDRA version: 14.1Level: LLTClassification code 10001164Term: Adenocarcinoma lung stage IIISystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10001165Term: Adenocarcinoma lung stage IVSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-014563-39-AT
• Lead Sponsor: Boehringer Ingelheim RCV GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-28
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1100

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, including consent to biomarker sampling, 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

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