A BRIDGING STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN IN NSCLC

• Drug: PF-06439535 (CN)
  15 mg/kg, IV on day 1 of each 21 day cycle for up to 2 years, or until progression or unacceptable toxicity develops.
• Drug: Bevacizumab-EU
  15 mg/kg, IV on day 1 of each 21 day cycle until disease progression, unacceptable toxicity or 25 weeks. At Week 25, the participants with clinical benefit will received PF-06439535 (CN) monotherapy for up to 2 years from randomization in this study
  Other Name: Avastin
• Drug: Paclitaxel
  175 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.
• Drug: Carboplatin
  AUC 5 (max=750mg) via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.

• Experimental: Arm A
  PF-06439535 (CN) + paclitaxel + carboplatin
  Interventions:

  • Drug: PF-06439535 (CN)
  • Drug: Paclitaxel
  • Drug: Carboplatin
• Active Comparator: Arm B
  Bevacizumab-EU + paclitaxel + carboplatin
  Interventions:

  • Drug: Bevacizumab-EU
  • Drug: Paclitaxel
  • Drug: Carboplatin

Inclusion Criteria:

• Male and female participants age at least 18 years of age.
• Newly diagnosed Stage IIIB, IIIC or IV non small cell lung cancer (NSCLC) (according to American Joint Committee on Cancer (AJCC) Staging Manual, 8th Edition, last updated 05 June 2018) or recurrent NSCLC.
• Histologically or cytologically confirmed diagnosis of non-squamous NSCLC.
• At least one measurable lesion as defined by RECIST v1.1.
• Be eligible to receive bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.

Exclusion Criteria:

• Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas.
• Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that, in the opinion of the investigator, is likely to bleed.
• Known EGFR activating mutations (for example, exon 19 deletion or exon 21 L858R substitution mutations) or ALK rearrangements.
• Prior systemic therapy for advanced NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.