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

Phase 1

• Conditions: Recurrent or metastatic disease (Stage IV), histologically or cytologically confirmed advanced nonsquamous Non-Small Cell Lung Cancer.; MedDRA version: 18.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1 Level: PT Classification code 10029515 Term: Non-small cell lung cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002161-30-GR
• Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-18
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 660

Inclusion Criteria

- 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

Exclusion Criteria

- 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