A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Pfizer
Study ID
NCT02364999
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab-Pfizer — DRUG
    Bevacizumab-Pfizer: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles, followed by the assigned blinded bevacizumab monotherapy.
  • Bevacizumab-EU — DRUG
    bevacizumab-EU: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles followed by the assigned blinded bevacizumab monotherapy.
  • Paclitaxel — DRUG
    Paclitaxel 200 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 — DRUG
    carboplatin AUC =6.0 via IV infusions on Day 1 of a 21-day cyclefor each of at least 4 and no more than six (6) 21-day cycles.

Study Details

This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.

Key Dates

First listed
Feb 18, 2015
Start date
Apr 30, 2015
Status verified
Jan 2019
Primary completion
May 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
719 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab-Pfizer
    Bevacizumab-Pfizer plus paclitaxel and carboplatin
  • Active Comparator: Bevacizumab-EU
    Bevacizumab-EU plus paclitaxel and carboplatin

Primary Outcome Measure

Objective Response Rate (ORR) by Week 19 [ Time Frame: 25 weeks ]

Locations (19)

FacilityCityStateZIPSite coordinators
Southern Cancer Center, PCDaphneAlabama36526-
Southern Cancer Center, PCMobileAlabama36607-
Southern Cancer Center, PCMobileAlabama36608-
Beaver Medical Group, L.P.HighlandCalifornia92346-
Cancer Center of Central ConnecticutNew BritainConnecticut06052-
Cancer Center of Central ConnecticutSouthingtonConnecticut06489-
Phoebe Putney Memorial HospitalAlbanyGeorgia31701-
Swedish Covenant HospitalChicagoIllinois60625-
Meritus Center for Clinical ResearchHagerstownMaryland21742-
Holy Cross HospitalSilver SpringMaryland20910-
Holy Cross Hospital Resource CenterSilver SpringMaryland20902-
Holy Cross Hospital, Hospital PharmacySilver SpringMaryland20910-
Maryland Oncology & Hematology, PASilver SpringMaryland20904-
Maryland Oncology & Hematology, PAWheatonMaryland20902-
St. Joseph's Regional Medical CenterPatersonNew Jersey07503-
Millennium OncologyHoustonTexas77090-
Millennium OncologyKingwoodTexas77339-
Millennium OncologyShenandoahTexas77384-
Millennium OncologyThe WoodlandsTexas77380-

Find similar trials in Daphne, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Southern Cancer Center, PC· Daphne, ALSouthern Cancer Center, PC· Mobile, ALBeaver Medical Group, L.P.· Highland, CACancer Center of Central Connecticut· New Britain, CTCancer Center of Central Connecticut· Southington, CTPhoebe Putney Memorial Hospital· Albany, GA

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