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NCT02855125 · ClinicalTrials.gov registry record · Phase 2
A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1
A Phase 2 study, sponsored by Taiho Oncology.
- Completed
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
NCT02855125: Completed Phase 2 study, sponsored by Taiho Oncology.
NCT02855125 is a Phase 2 study that has completed, run by Taiho Oncology. The registered enrollment target is 128 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02855125, a Phase 2 study, has completed, sponsored by Taiho Oncology.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
Study Summary
This is a randomized, open-label, Phase 2 study of TAS-114 administered in combination with S-1, to investigate the efficacy, safety and tolerability of the TAS-114/S-1 regimen in patients with advanced or metastatic NSCLC. The study will be conducted internationally in 2 regions: Asian \[Japan\] and Western \[Europe and US\]. Patients will be randomized into TAS-114/S-1 arm versus S-1 control arm in a 1:1 ratio.
Primary Outcome
Progression-free survival was defined as the time (in months) from the day of randomization to the start of radiologic disease progression or death (any cause), whichever occurred first. Response assessments were made based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). As per RECIST 1.1 criteria, progressive disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if
Interventions
- DRUG S-1
- DRUG TAS-114
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2016-08-29 |
| Est. Completion | 2017-11-30 |
| Phase | Phase 2 |
What the finished NCT02855125 record still lists
NCT02855125 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which S-1 is the first listed.
NCT02855125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02855125 about?
NCT02855125 is a clinical study titled "A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1". This is a randomized, open-label, Phase 2 study of TAS-114 administered in combination with S-1, to investigate the efficacy, safety and tolerability of the TAS-114/S-1 regimen in patients with advanced or metastatic NSCLC. The study will be conducted internationally in 2 regions: Asian \[Japan\] a...
What is the current status of trial NCT02855125?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2016-08-29. Estimated completion is 2017-11-30.
What interventions are being tested in trial NCT02855125?
The interventions under investigation include: S-1 (DRUG), TAS-114 (DRUG).
Who is sponsoring clinical trial NCT02855125?
This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02855125's enrollment target sits among peer trials
128 553rd of 2000 higher than 1,446 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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