Ph II of a Novel Anti-angiogenic Agent in Combination With Chemotherapy for the Treatment of Non-Small Cell Lung Cancer

Study summary

The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPaclitaxel and Carboplatin

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 12, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?55 U.S. locations

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Bristol-Myers Squibb
Interventions being studied: Drug: Paclitaxel; Drug: Carboplatin; Drug: CT-322; Drug: Bevacizumab; Drug: Bevacizumab placebo (ie saline solution)

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Recurrent or relapsed→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
ECOG Performance Status (PS) \<=1
Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC
Measurable disease by RECIST guidelines

Reasons someone may not be able to joinExclusion criteria

Evidence of predominantly squamous-cell histology
Known CNS metastases
Any prior antineoplastic systemic regimens for NSCLC
Excessive risk of bleeding (including use of therapeutic anticoagulation) and history of thrombotic or embolic cerebrovascular accident
Gross hemoptysis (≥1/2 tsp of red blood)
Uncontrolled hypertension
Clinically significant cardiovascular disease
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Acrc/Arizona Clinical Research Center, Inc.Tucson, Arizona
Sharp Clinical Oncology ResearchSan Diego, California
Cancer Institute Of FloridaOrlando, Florida
Palm Beach Cancer InstituteWest Palm Beach, Florida
Clintell, Inc.Skokie, Illinois
Cancer Center Of KansasWichita, Kansas
Kentucky Cancer ClinicHazard, Kentucky
Annapolis Oncology CenterAnnapolis, Maryland
Meritus Center For Clinical ResearchHagerstown, Maryland
North Mississippi Hematology And Oncology Associates, LtdTupelo, Mississippi
Piedmont Hematology Oncology Associates, PllcWinston-Salem, North Carolina
North Canton Medical Clinic CenterCanton, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 12, 2015. Always confirm current availability with the study team.

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