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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: Completed Phase 3 study, sponsored by Celgene.
NCT02027428 is a Phase 3 study that has completed, run by Celgene. The registered enrollment target is 427 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 resp
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 |
What the finished NCT02027428 record still lists
NCT02027428 is an interventional study that assigns participants to a tested intervention. The registered 427 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 4 interventions - of which Abraxane (Induction) is the first listed.
NCT02027428 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02027428's enrollment target sits among peer trials
427 880th of 2000 higher than 1,119 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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