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NCT02027428 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 427
- Enrollment target
NCT02027428 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 427 participants.
The verdict
NCT02027428, a Phase 3 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 427 participants
- Enrollment target
Study Summary
Maintenance treatment of advanced stage squamous cell NSCLC. Phase III, randomized, open-label, multi-center study of nab-paclitaxel with best supportive care (BSC) or BSC alone as maintenance treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin as induction in subjects with stage IIIB/IV squamous cell NSCLC. Subjects who discontinued treatment from the maintenance part for any reason other than withdrawal of consent, lost to follow-up, or death, were entered into a Follow-up period that had a visit 28 days after progression or discontinuation. Those who entered Follow-up without progression continued with follow-up scans according to standard of care (SOC) until documentation of progression of disease. Additionally, subjects were followed for OS by phone approximately every 90 days for a minimum of 18 months, for up to approximately 5 years after the last subject was randomized.
Interventions
- DRUG Abraxane (Induction)
- DRUG Carboplatin (Induction)
- DRUG Abraxane (Maintenance)
- OTHER Best Supportive Care (Maintenance)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 427 participants |
| Start Date | 2014-02-11 |
| Est. Completion | 2019-08-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02027428
The ClinicalTrials.gov registry entry for NCT02027428 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 427 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Abraxane (Induction) is the first listed.
NCT02027428 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02027428 about?
NCT02027428 is a clinical study titled "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". Maintenance treatment of advanced stage squamous cell NSCLC. Phase III, randomized, open-label, multi-center study of nab-paclitaxel with best supportive care (BSC) or BSC alone as maintenance treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin as induction in subje...
What is the current status of trial NCT02027428?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 427 participants. The study started on 2014-02-11. Estimated completion is 2019-08-01.
What interventions are being tested in trial NCT02027428?
The interventions under investigation include: Abraxane (Induction) (DRUG), Carboplatin (Induction) (DRUG), Abraxane (Maintenance) (DRUG), Best Supportive Care (Maintenance) (OTHER).
Who is sponsoring clinical trial NCT02027428?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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