Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: BI 695502; Avastin
Intervention MeSH terms: Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 671.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this phase III trial is 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®.
    

Eligibility criteria:

        Inclusion criteria:

        Adult patients aged >=18 years with histologically or cytologically confirmed advanced
        nonsquamous non-small cell lung cancer (nsNSCLC). Mixed tumors should be categorized
        according 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 factor
        receptor (EGFR) / anaplastic lymphoma receptor tyrosine kinase (ALK) mutation maybe
        included provided chemotherapy is standard of care. At least one measurable lesion
        according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on independent
        central 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 Vascular
        Endothelial Growth Factor (VEGF) or VEGF receptors, including Avastin®.

        Prior systemic therapy for metastatic disease. Prior systemic anticancer therapy or
        radiotherapy 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 of
        the skin or pre-invasive cancer of the cervix.

        Symptomatic brain metastasis. Diagnosis of small cell carcinoma of the lung, squamous cell
        carcinoma of the lung, NSCLC not specified (NS) or NSCLC not otherwise specified(NOS).

        Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from previous
        anticancer therapy (including radiotherapy).

        History or evidence of inherited bleeding diathesis or coagulopathy with the risk of
        bleeding. Thrombotic or hemorrhagic event =< 6 months prior to Screening. Further exclusion
        criteria apply.