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

A Randomized Double-Blinded Phase II Study of Carboplatin/Paclitaxel/CT-322 Versus Carboplatin/Paclitaxel/Bevacizumab as First-Line Treatment for Recurrent or Advanced Non-Small Cell Lung Cancer With Non-Squamous Histology

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00850577

Enrollment

255

Registered

2009-02-25

Start date

2009-06-30

Completion date

2013-08-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer (NSCLC)

Brief 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

Interventions

DRUGPaclitaxel

Solution, IV, 200 mg/m2, Q21days, 6 cycles

DRUGCarboplatin

Solution, IV, AUC=6, Q21days, 6 cycles

DRUGCT-322

Solution, IV, 2 mg/kg, Q7days, Until PD

DRUGBevacizumab

Solution, IV, 15 mg/kg, Q21days, Until PD

DRUGBevacizumab placebo (ie saline solution)

Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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. Inclusion Criteria: * ECOG Performance Status (PS) \<=1 * Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC * Measurable disease by RECIST guidelines

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Progression free survival based on tumor assessments (CT scans/MRI)	every 6 weeks until documented progressive disease , death or initiation of subsequent therapy for NSCLC

Secondary

Measure	Time frame
Overall survival (OS) between 2 arms	every 12 weeks
Objective tumor response rate (ORR) between 2 arms	every 6 weeks
Safety in the CT-322 plus carboplatin and paclitaxel arm	weekly

Countries

Brazil, France, Italy, Poland, Russia, South Africa, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026