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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Drug: Bevacizumab; Drug: Bevacizumab placebo (ie saline solution); Drug: CT-322; Drug: Carboplatin; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00850577

EUDRACT# 2008-007768-41

CA196-005

Details and patient eligibility

About

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

Enrollment: 255 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email [e-mail]. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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255 participants in 2 patient groups

Paclitaxel/Carboplatin/CT-322

Active Comparator group

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: CT-322

Paclitaxel/Carboplatin/Bevacizumab/Placebo

Active Comparator group

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: Bevacizumab placebo (ie saline solution)

Drug: Bevacizumab