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



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/9/2019
Start Date:April 2015
End Date:December 2017

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A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF- 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL -CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER.

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.


Inclusion Criteria:

- Male and female patients age at least 18 years of age, or age of consent in the
region.

- Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised
International System for Staging Lung Cancer criteria of 2010) or recurrent non-small
cell lung cancer (NSCLC).

- Histologically or cytologically confirmed diagnosis of predominately non-squamous
NSCLC.

- Be eligible to receive study treatment of 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 of predominantly squamous nature.

- Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation
that is likely to bleed.

- Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK
translocation positive mutations.

- Prior systemic therapy for NSCLC; prior neoadjuvant or adjuvant therapy is allowed if
surgical resection for primary disease was performed.
We found this trial at
20
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Mobile, Alabama 36608
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Albany, Georgia 31701
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Albany, GA
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Chicago, Illinois 60625
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Chicago, IL
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Daphne, Alabama 36526
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Daphne, AL
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Hagerstown, Maryland 21740
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Hagerstown, MD
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Highland, California 92346
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Highland, CA
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Houston, Texas 77090
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Houston, TX
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22710 Professional Drive
Kingwood, Texas 77339
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Kingwood, TX
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Lismore, New South Wales 2480
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Lismore,
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Mobile, Alabama 36608
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Mobile, AL
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New Britain, Connecticut 06052
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New Britain, CT
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Paterson, New Jersey 07503
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Paterson, NJ
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Shenandoah, Texas 77384
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Shenandoah, TX
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Silver Spring, Maryland 20910
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Silver Spring, MD
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Silver Spring, Maryland 20902
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Silver Spring, MD
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12210 Plum Orchard Drive
Silver Spring, Maryland 20902
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Silver Spring, MD
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1500 Forest Glen Road
Silver Spring, Maryland 20910
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Silver Spring, MD
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Southington, Connecticut 06489
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Southington, CT
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9319 Pinecroft Drive
The Woodlands, Texas 77380
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The Woodlands, TX
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Wheaton, Maryland 20902
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Wheaton, MD
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