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NCT03322540 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)
A Phase 2 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
NCT03322540: Completed Phase 2 study, sponsored by Incyte Corporation.
NCT03322540 is a Phase 2 study that has completed, run by Incyte Corporation. The registered enrollment target is 154 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03322540, a Phase 2 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).
Primary Outcome
ORR is defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on blinded independent central review (BICR).
Interventions
- DRUG Pembrolizumab
- DRUG Placebo
- DRUG Epacadostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2017-12-15 |
| Est. Completion | 2020-11-09 |
| Phase | Phase 2 |
What the finished NCT03322540 record still lists
NCT03322540 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03322540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03322540 about?
NCT03322540 is a clinical study titled "Pembrolizumab Plus Epacadostat vs Pembrolizumab Plus Placebo in Metastatic Non-Small Cell Lung Cancer (KEYNOTE-654-05/ECHO-305-05)". The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus epacadostat compared to pembrolizumab plus placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death ligand 1 (PD-L1).
What is the current status of trial NCT03322540?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2017-12-15. Estimated completion is 2020-11-09.
What interventions are being tested in trial NCT03322540?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), Epacadostat (DRUG).
Who is sponsoring clinical trial NCT03322540?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03322540's enrollment target sits among peer trials
154 448th of 2000 higher than 1,552 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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