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: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: 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-HU
• Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-05
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 671

Inclusion Criteria

- Aged =18 years (for Japan only: Age =20 years at Screening)
- 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. Despite EGFR/ALK mutational status, patients may enter the trial if the site's best standard of care would be administer such a chemotherapy regimen for that specific patient. However, if an EGFR/ALK test result is pending, and chemotherapy treatment would be switched in case of a mutational positive result, patients may not be included in this trial.
-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 410
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 261

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) .
- Known 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