Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00347412 | Study of NOV-002 in Combination With Chemotherapy to Treat Lung Cancer | PHASE3 | COMPLETED | 903 | — | — | Nov 1, 2006 | Feb 1, 2010 | Jul 25, 2022 | 75 | United States, Canada +10 |
| Arm | Type | Description |
|---|---|---|
| Group A: NOV-002 plus Chemotherapy | EXPERIMENTAL | NOV-002 in combination with Paclitaxel and Carboplatin |
| Group B: Chemotherapy Alone | ACTIVE_COMPARATOR | Paclitaxel and Carboplatin |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | Paclitaxel is dosed at 200 mg/m2, as a 3 hour infusion. All randomized patients will follow the established 21-day cycle of paclitaxel and carboplatin including the administration of pre-medications for these products per the package inserts. Paclitaxel and carboplatin cycles will be administered until documented disease progression or completion of 6 cycles of paclitaxel and carboplatin in the absence of response or unacceptable related toxicity, whichever comes first. |
| NOV-002 | DRUG | * Two 60 mg intravenous boli given 3 hours apart administered the day prior to the first administration of paclitaxel and carboplatin cycle one * For each nominal 21-day paclitaxel and carboplatin cycle: * 60 mg given intravenously on Day 1, given one hour prior to paclitaxel and carboplatin * followed by 60 mg subcutaneously daily for the next 20 days. If there is a delay in chemotherapy cycles, the patient will continue with daily, subcutaneous administration of NOV-002 until the next cycle of chemotherapy begins Patients randomized to NOV-002 Group A, will receive NOV-002 until disease progression, unacceptable NOV-002 related toxicity, or discontinuation of paclitaxel and carboplatin, whichever comes first. |
| Carboplatin | DRUG | Carboplatin is dosed at an area under the curve (AUC) of 6 mg/mL/min using the Calvert equation for carboplatin dosing. All randomized patients will follow the established 21-day cycle of paclitaxel and carboplatin including the administration of pre-medications for these products per the package inserts. Paclitaxel and carboplatin cycles will be administered until documented disease progression or completion of 6 cycles of paclitaxel and carboplatin in the absence of response or unacceptable related toxicity, whichever comes first. The initial dose of chemotherapy for every patient in the trial is 200 mg/m2 of paclitaxel, as a 3 hour infusion, followed by carboplatin at an area under the curve (AUC) of 6 mg/mL/min using the Calvert equation for carboplatin dosing. |
Inclusion Criteria: * Diagnosis of Stage IIIb with malignant pleural or pericardial effusion or Stage IV (American Joint Committee on Cancer \[AJCC\]) NSCLC * ECOG performance score of 0 or 1 * Adequate bone marrow, hepatic, and renal function * New York Heart Association (NYHA) score 1-2 * Life ex...