A Comparative Study of BAT1706 and EU Avastin® in Patients With Advanced Non Squamous Non Small Cell Lung Cancer
Condition: Non-squamous Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: EU Avastin®; BAT1706; Paclitaxel; carboplatin
Intervention description: 100 mg/4 mL; 100 mg/4 mL; 200 mg/m²; target area under the curve [AUC] 6 mg/mL•minute
Intervention MeSH terms: Paclitaxel; Carboplatin; Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 651.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase III, randomized, double blind, multicenter, active comparator, parallel two
      arm study to compare the efficacy, and to evaluate the safety, and immunogenicity of BAT1706
      to EU Avastin® in patients with previously untreated advanced non-squamous non-small cell
      lung cancer (nsNSCLC) to demonstrate clinical equivalence of BAT1706 and EU Avastin®.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Stage IV nsNSCLC or recurrent disease (any Stage at initial diagnosis) no longer
             amenable to curative surgery or local therapy (histologically or cytologically
             confirmed).

          2. No prior systemic therapy for metastatic disease. Prior systemic therapy and/or
             radiotherapy for locally advanced disease is permitted if completed ≥ 6 months prior
             to randomization.

          3. Tumors without activating EGFR or ALK mutation. Patients with unknown mutation status
             or known activating EGFR or ALK mutation may be included provided the corresponding
             targeted agent is not available and chemotherapy is the standard of care of the study
             center.

          4. At least one measurable target lesion according to RECIST 1.1 (Appendix 13.4) as
             confirmed by CIR; bone only and brain-only metastases are not allowed. Lesions
             previously treated with radiotherapy are non-target lesion.

          5. Eastern Cooperative Oncology Group performance status of 0 or 1 and life expectancy >
             3 months based on Investigator's judgment.

        Exclusion Criteria:

          1. Diagnosis of small cell carcinoma of the lung, mixed predominant squamous cell
             carcinoma of the lung, NSCLC not otherwise specified.

          2. Tumor cavitation, tumor invading into large blood vessels or close to large vessels
             with an increased risk of bleeding, according to Investigator's judgment.

          3. Prior therapy with monoclonal antibodies or small molecule inhibitors against VEGF or
             VEGFR, including Avastin®.

          4. Prior systemic therapy for metastatic disease.

          5. Prior systemic anticancer therapy, or radiotherapy for locally advanced nsNSCLC if
             completed < 6 months prior to screening.

          6. 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.