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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02027428 | Safety and Efficacy Study of Abraxane as Maintenance Treatment After Abraxane Plus Carboplatin in 1st Line Stage IIIB / IV Squamous Cell Non-small Cell Lung Cancer | PHASE3 | COMPLETED | 427 | — | — | Feb 11, 2014 | Aug 1, 2019 | Aug 17, 2020 | 119 | United States, Germany +3 |
Progression-free survival is defined as the time in months from the date of randomization to the date of disease progression based on the investigator's assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria (documented by computerized axial tomography \[CT scan\], not including symptomatic deterioration) or death (any cause) on or prior to 01 Aug 2019. RECIST 1.1 Definition: - Complete response (CR) -disappearance of all target lesions; - Partial response (PR) -at least a 30% decrease in the sum of diameters of target lesions from baseline - Stable disease (SD) -neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase of lesions to qualify for progressive disease (PD) - Progressive Disease (PD) - At least a 20% increase in the sum of diameters of target lesions from nadir, and/or the appearance of new lesions.
| Arm | Type | Description |
|---|---|---|
| Abraxane + Best Supportive Care (BSC) | EXPERIMENTAL | Dosing will occur in two phases - induction and maintenance. During induction, the subject will receive Abraxane plus carboplatin as standard of care. At the end of 4 cycles, if the subject has a complete response, partial response, or stable disease, he/she will continue on to the maintenance phase. Maintenance dosing on this arm includes Abraxane plus best supportive care. |
| Best Supportive Care (BSC) | OTHER | Dosing will occur in two phases - induction and maintenance. During induction, the subject will receive Abraxane plus carboplatin as standard of care. At the end of 4 cycles, if the subject has a complete response, partial response, or stable disease, he/she will continue on to the maintenance phase. Maintenance dosing on this arm includes best supportive care only. |
| Name | Type | Description |
|---|---|---|
| Abraxane (Induction) | DRUG | 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care |
| Carboplatin (Induction) | DRUG | 6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion |
| Abraxane (Maintenance) | DRUG | 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, administered as standard of care |
| Best Supportive Care (Maintenance) | OTHER | The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents |
Inclusion Criteria: 1. Age ≥ 18 years of age at the time of signing the Informed Consent Form. 2. Understand and voluntarily provide written consent to the Informed Consent Form prior to conducting any study related assessments/procedures. 3. Able to adhere to the study visit schedule and other pro...