BI 1361849 (CV9202) + afatinib compared with placebo + afatinib in first-line NSCLC harbouring common EGFR mutations
- Conditions
- Advanced non-small cell lung cancer (adenocarcinoma) stage IV.MedDRA version: 18.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-001477-41-ES
- Lead Sponsor
- Boehringer Ingelheim España, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 199998
?Pathologically confirmed diagnosis of stage IV adenocarcinoma of the lung
?Documented activating EGFR mutation (Del 19 and/or L858R) determined in tumour tissues
?Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
?Measurable disease according to the Response Evaluation Criteria in Solid Tumours (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 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
?Prior systemic chemotherapy for relapsed and/or metastatic NSCLC
?Prior treatment with EGFR targeting small molecules or antibodies
?Known allergy to protamine or fish protein
?Known type I allergy to penicillin or other beta-lactam antibiotics
?Known autoimmune disorder or propensity for severe hypersensitivity reactions
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate efficacy, immunogenicity and safety of BI 1361849 (CV9202) in combination with afatinib, as first-line treatment for patients with stage IV adenocarcinoma of the lung harbouring common EGFR mutations<br><br>Phase I: To confirm feasibility and safety of the combination of BI 1361849 (CV9202) with afatinib, and to assess immunological responses of BI 1361849 (CV9202) in combination with afatinib in comparison to placebo plus afatinib <br><br>Phase II (analyses will cover all randomised patients, i.e. will also include all patients randomised during the phase I part of the trial): To assess efficacy, immunogenicity and safety of BI 1361849 (CV9202) in combination with afatinib in comparison to placebo plus afatinib;Secondary Objective: Not applicable;Primary end point(s): Progression-free survival (PFS) by central independent review according to RECIST 1.1;Timepoint(s) of evaluation of this end point: 52, 90 and 156 weeks after randomisation of the last patient.
- Secondary Outcome Measures
Name Time Method