Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer

Inclusion criteria: Adult patients aged >=18 years with histologically or cytologically confirmed advancednonsquamous non-small cell lung cancer (nsNSCLC). Mixed tumors should be categorizedaccording to the predominant histology. Note: NSCLC should be predominantly nonsquamous. Recurrent or metastatic disease (Stage IV)with an indication for therapy with paclitaxel + carboplatin + Avastin®. Patients harboring tumors with unknown or without activating epidermal growth factorreceptor (EGFR) / anaplastic lymphoma receptor tyrosine kinase (ALK) mutation maybeincluded provided chemotherapy is standard of care. At least one measurable lesionaccording to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on independentcentral review. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Adequate hepatic, renal, and bone marrow function: Life expectancy > 6 months based on clinical judgment. Further inclusion criteria apply.

Exclusion criteria: Prior therapy with monoclonal antibodies or small molecule inhibitors against VascularEndothelial Growth Factor (VEGF) or VEGF receptors, including Avastin®. Prior systemic therapy for metastatic disease. Prior systemic anticancer therapy orradiotherapy for locally advanced nsNSCLC if completed <12 months prior to Screening. Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer ofthe skin or pre-invasive cancer of the cervix. Symptomatic brain metastasis. Diagnosis of small cell carcinoma of the lung, squamous cellcarcinoma of the lung, NSCLC not specified (NS) or NSCLC not otherwise specified(NOS). Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from previousanticancer therapy (including radiotherapy). History or evidence of inherited bleeding diathesis or coagulopathy with the risk ofbleeding. Thrombotic or hemorrhagic event =< 6 months prior to Screening. Further exclusioncriteria apply.