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NCT02591615 · ClinicalTrials.gov registry record · Phase 2
Optimal Sequencing of Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in First-Line NSCLC
A Phase 2 study, sponsored by Alliance Foundation Trials.
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
NCT02591615: Completed Phase 2 study, sponsored by Alliance Foundation Trials.
NCT02591615 is a Phase 2 study that has completed, run by Alliance Foundation Trials. The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02591615, a Phase 2 study, has completed, sponsored by Alliance Foundation Trials.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
Study Summary
This is a multicenter randomized phase II to determine if the administration of standard platinum-based chemotherapy before MK-3475 in with Chemotherapy naive stage IV Non-small Cell Lung Cancer (NSCLC) will improve the overall response rate (ORR) compared to MK-3475 administered before chemotherapy. Patients will be given Pembrolizumab as maintenance up to 2 years: Carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by pembrolizumab every 3 weeks for up to 2 years. Pembrolizumab every 3 weeks x 4 cycles followed by carboplatin and paclitaxel or pemetrexed every 3 weeks x 4 cycles followed by pembrolizumab every 3 weeks for up to 2 years.
Primary Outcome
The primary objective of this randomized phase II trial to determine the overall response rate (ORR per RECIST 1.1) in Chemotherapy naive patients with stage IV NSCLC after the administration of standard platinum-based chemotherapy before MK-3475 (arm A) and administration of MK-3475 administered before standard platinum-based chemotherapy (arm B). Overall Response (OR) = CR + PR.
Interventions
- DRUG Carboplatin
- DRUG Pemetrexed
- DRUG Paclitaxel
- DRUG MK-3475
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2016-03 |
| Est. Completion | 2020-07-04 |
| Phase | Phase 2 |
What the finished NCT02591615 record still lists
NCT02591615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT02591615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02591615 about?
NCT02591615 is a clinical study titled "Optimal Sequencing of Pembrolizumab (MK-3475) and Standard Platinum-based Chemotherapy in First-Line NSCLC". This is a multicenter randomized phase II to determine if the administration of standard platinum-based chemotherapy before MK-3475 in with Chemotherapy naive stage IV Non-small Cell Lung Cancer (NSCLC) will improve the overall response rate (ORR) compared to MK-3475 administered before chemotherapy...
What is the current status of trial NCT02591615?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2016-03. Estimated completion is 2020-07-04.
What interventions are being tested in trial NCT02591615?
The interventions under investigation include: Carboplatin (DRUG), Pemetrexed (DRUG), Paclitaxel (DRUG), MK-3475 (DRUG).
Who is sponsoring clinical trial NCT02591615?
This trial is sponsored by Alliance Foundation Trials, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02591615's enrollment target sits among peer trials
91 771st of 2000 higher than 1,229 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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