A study evaluating the efficacy and safety of BI 695502 plus chemotherapy versus Avastin® plus chemotherapy in patients with advanced nonsquamous Non-Small Cell Lung Cancer
- Conditions
- Recurrent or metastatic disease (Stage IV), histologically or cytologically confirmed advanced nonsquamous Non-Small Cell Lung Cancer.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: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002161-30-ES
- Lead Sponsor
- Boehringer Ingelheim International GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 660
- Aged ?18 years (for Japan only: Age ?20 years at Visit 1)
- Recurrent or metastatic disease (Stage IV) with an indication for therapy with
paclitaxel + carboplatin + Avastin®
- Negative epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation status. Patients harboring tumors with unknown or positive EGFR or ALK mutation may be included, provided chemotherapy is the site standard-of-care for those patients.
-Patients must have at least one measurable lesion according to RECIST 1.1, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Life expectancy >6 months based on clinical judgment.
-Patients must have adequate hepatic, renal, and bone marrow function.
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 383
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 277
- Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or VEGF receptors, including Avastin®.
- Prior systemic therapy for metastatic disease ( Prior systemic therapy and/or radiotherapy for locally advanced disease permitted if completed >12 months prior to Screening) .
- Symptomatic brain metastasis.
- Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung,
NSCLC NS (not specified) or NSCLC NOS (not otherwise specified).
- Contraindication to bevacizumab
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Best ORR based on unconfirmed response assessment as assessed by central imaging review until 18 weeks after the start of treatment.;Timepoint(s) of evaluation of this end point: Efficacy : Screening, Weeks 0, 6,12,18 visit;Main Objective: To establish statistical equivalence in terms of efficacy (best overall response rate [ORR] ,proportion of patients with complete response [CR] plus partial response [PR]) until 18 weeks of first-line treatment with BI 695502 plus chemotherapy versus Avastin® plus chemotherapy followed by maintenance monotherapy with either BI 695502 or Avastin®.;Secondary Objective: The secondary objectives are to evaluate further efficacy parameters, the safety and tolerability of BI 695502 versus Avastin®.<br>Further objectives are to evaluate the PK of BI 695502 versus Avastin® as well as the presence of antidrug antibodies (ADAs) and neutralizing antidrug antibodies (nADAs).
- Secondary Outcome Measures
Name Time Method