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

PHASE3TerminatedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

June 11, 2020

Primary Completion Date

May 10, 2021

Study Completion Date

May 10, 2021

Conditions
Advanced Non-squamous NSCLC
Interventions
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

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.

Trial Locations (4)

250013

Jinan Central Hospital, Jinan

300052

Tianjin Medical University General Hospital, Tianjin

523059

Dongguan People's Hospital, Dongguan

071000

Affiliated Hospital of Hebei University, Baoding

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT04325698 - A BRIDGING STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN IN NSCLC | Biotech Hunter | Biotech Hunter