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

Completed · Phase 3

Conditions studied: Non-Small Cell Lung Cancer

In brief

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 facts

Study ID

NCT02364999

Run by

Pfizer

People needed

719

Starts

2015-04-01

Expected to finish

2017-12-01

Last updated by the study team

2019-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Southern Cancer Center, PC — Mobile, Alabama, United States
• Southern Cancer Center, PC — Mobile, Alabama, United States
• Beaver Medical Group, L.P. — Highland, California, United States
• Cancer Center of Central Connecticut — New Britain, Connecticut, United States
• Cancer Center of Central Connecticut — Southington, Connecticut, United States
• Phoebe Putney Memorial Hospital — Albany, Georgia, United States
• Swedish Covenant Hospital — Chicago, Illinois, United States
• Meritus Center for Clinical Research — Hagerstown, Maryland, United States
• Holy Cross Hospital Resource Center — Silver Spring, Maryland, United States
• Maryland Oncology & Hematology, PA — Silver Spring, Maryland, United States
• Holy Cross Hospital, Hospital Pharmacy — Silver Spring, Maryland, United States
• Holy Cross Hospital — Silver Spring, Maryland, United States
• Maryland Oncology & Hematology, PA — Wheaton, Maryland, United States
• St. Joseph's Regional Medical Center — Paterson, New Jersey, United States
• Millennium Oncology — Houston, Texas, United States
• Millennium Oncology — Kingwood, Texas, United States
• Millennium Oncology — Shenandoah, Texas, United States
• Millennium Oncology — The Woodlands, Texas, United States
• Epic Pharmacy — Lismore, New South Wales, Australia
• The Tweed Hospital — Tweed Heads, New South Wales, Australia
• Cardiac Services, John Flynn Private Hospital - — Tugun, Queensland, Australia
• South Coast Radiology, John Flynn Private Hospital — Tugun, Queensland, Australia
• Austin Health - Olivia Newton - John Cancer & Wellness Centre — Heidelberg, Victoria, Australia
• Western Health, Sunshine Hospital — St Albans, Victoria, Australia
• Southern Cancer Center, PC — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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