Patients with advanced NSCLC MedDRA version: 9.1 Level: LLT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB
Conditions
Interventions
Trade Name: Glutoxim
Pharmaceutical Form: Solution for injection
INN or Proposed INN: bis-(gamma-L-glutamyl)-L-cysteinyl-bis-glycin disodium salt
CAS Number: 103239-24-3
Current Sponsor code: NOV-002
Sponsors
NOVELOS THERAPEUTICS INC.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine whether patients with advanced NSCLC receiving NOV-002 in combination with paclitaxel and carboplatin have improved overall survival as compared to patients receiving paclitaxel and carboplatin alone;Primary end point(s): Determine whether patients with advanced NSCLC receiving NOV-002 in combination with paclitaxel and carboplatin have improved overall survival as compared to patients receiving paclitaxel and carboplatin alone.;Secondary Objective: Secondary Endpoints: Determine whether patients with advanced NSCLC receiving NOV-002 in combination with paclitaxel and carboplatin have: a. Improved progression-free survival (PFS) b. Higher anti-tumor overall response rate (ORR) c. Increased response duration d. A better quality of life (QOL) as determined with the EORTC QLQ-C30 instrument with LC13 module e. Less myelosuppression and improved recovery from chemotherapy-induced myelosuppression f. Immunomodulation as evidenced by changes in lymphocyte subsets g. A similar safety profile as compared to patients that received paclitaxel and carboplatin alone. Additionally, to evaluate pharmacokinetics (PK) of NOV-002. | — |
Countries
Italy, United Kingdom
Outcome results
None listed