A Randomized, Open-Label, Phase 3 Trial of NOV-002 in Combination withPaclitaxel and Carboplatin vs. Paclitaxel and Carboplatin Alone for theTreatment of Advanced Non-Small-Cell Lung Cancer (NSCLC) - ND

Active, not recruiting

• Conditions: Patients with advanced NSCLC; MedDRA version: 9.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIB

• Registration Number: EUCTR2006-001990-32-IT
• Lead Sponsor: OVELOS THERAPEUTICS INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 840

Inclusion Criteria

Patients age >= 18 years of age, with histologically or cytologically

confirmed Stage IIIb with malignant pleural or pericardial effusion or

Stage IV (AJCC) NSCLC. Patients may have received prior treatment for

NSCLC as described in the inclusion/exclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(1) Prior chemotherapy for advanced NSCLC or the patient has received prior

neoadjuvant or adjuvant chemotherapy for NSCLC in the year prior to the

date of randomization

(2) Patients with CNS metastases

(3) Any systemic disease precluding chemotherapy

(4) Chronic use of systemic corticosteroids in pharmacological doses

(5) Known or history of HIV, HBV or HCV

(6) Palliative radiation therapy within 3 weeks prior to randomization

(7) Major surgery within 3 weeks prior to randomization

(8) Myocardial infarction within the 3 months prior to randomization

(9) Peripheral neuropathy > grade 2

(10) Patients that have had a splenectomy

(11) Contraindication to treatment with paclitaxel or carboplatin or any of the

components of NOV-002

(12) Any known preexisting medical condition, including substance abuse, that

could interfere with the patient's participation in and completion of the

protocol

(13) Have received any investigational drug, defined as a drug for which there is

no FDA approved indication, within the 30 days prior to randomization

(14) Pregnant female or nursing mother

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified