A BRIDGING STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN IN NSCLC
- Sponsor
- Pfizer
- Study ID
- NCT04325698
- Phase
- PHASE3
- Status
- Terminated
Conditions
- Advanced Non-squamous NSCLC
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- PF-06439535 (CN) — DRUG15 mg/kg, IV on day 1 of each 21 day cycle for up to 2 years, or until progression or unacceptable toxicity develops.
- Bevacizumab-EU — DRUG15 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
- Paclitaxel — DRUG175 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.
- Carboplatin — DRUGAUC 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.
Study Details
The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-06439535 (CN) in combination with paclitaxel and carboplatin versus bevacizumab sourced from the European Union (bevacizumab-EU) with paclitaxel and carboplatin in Chinese participants with advanced non-squamous NSCLC in the first-line treatment setting.
Key Dates
- First listed
- Mar 27, 2020
- Start date
- Jun 11, 2020
- Status verified
- Jun 2024
- Primary completion
- May 10, 2021
- Completion
- May 10, 2021
Study Design
- Enrollment
- 8 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm APF-06439535 (CN) + paclitaxel + carboplatin
- Active Comparator: Arm BBevacizumab-EU + paclitaxel + carboplatin
Primary Outcome Measure
Percentage of Participants Achieving Objective Response [ Time Frame: From Week 1 to Week 25 (25 Weeks) ]