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NCT02588261 · ClinicalTrials.gov registry record · Phase 3
A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations
A Phase 3 study, sponsored by Astellas Pharma Global Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 530
- Enrollment target
NCT02588261: Clinical Trial Phase 3 study, sponsored by Astellas Pharma Global Development.
NCT02588261 is a Phase 3 study that was terminated before completion, run by Astellas Pharma Global Development. The registered enrollment target is 530 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02588261, a Phase 3 study, was terminated before completion, sponsored by Astellas Pharma Global Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 530 participants
- Enrollment target
Study Summary
The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations. This study also assessed Overall survival (OS); Overall response rate (ORR) as assessed by IRR; PFS as assessed by the investigator; Disease control rate (DCR) as assessed by IRR; Duration of Response (DOR) by IRR; Safety of ASP8273; and Quality of Life (QOL) and patient-reported outcome (PRO) parameters.
Primary Outcome
PFS was defined as the time from the date of randomization until the date of radiological disease progression or until death due to any cause, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by IRR. Results are based Kaplan-Meier estimate. If a participant had neither progressed nor died, who received any further anticancer therapy for the disease before radiological progression, the participant was censored at the date of last radiological assessment. If pro
Interventions
- DRUG Gefitinib
- DRUG Erlotinib
- DRUG naquotinib mesilate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2016-02-11 |
| Est. Completion | 2017-12-21 |
| Phase | Phase 3 |
Why NCT02588261 stopped before completion
NCT02588261 is an interventional study that assigns participants to a tested intervention. The registered 530 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 (31% lower).
The record links to 0 conditions, and to 3 interventions - of which Gefitinib is the first listed.
NCT02588261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02588261 about?
NCT02588261 is a clinical study titled "A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations". The purpose of the study was to evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-small cell lung cancer (NSCLC) with...
What is the current status of trial NCT02588261?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2016-02-11. Estimated completion is 2017-12-21.
What interventions are being tested in trial NCT02588261?
The interventions under investigation include: Gefitinib (DRUG), Erlotinib (DRUG), naquotinib mesilate (DRUG).
Who is sponsoring clinical trial NCT02588261?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02588261's enrollment target sits among peer trials
530 706th of 2000 higher than 1,292 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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