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NCT03631784 · ClinicalTrials.gov registry record · Phase 2
A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 216
- Enrollment target
NCT03631784: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT03631784 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 216 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03631784, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 216 participants
- Enrollment target
Study Summary
This is a trial in adult participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC) treated with pembrolizumab in combination with platinum doublet chemotherapy and standard thoracic radiotherapy followed by pembrolizumab monotherapy. The primary hypothesis of the trial is that within each platinum doublet chemotherapy cohort, the percentage of participants who develop Grade 3 or higher pneumonitis is ≤10% and estimation of objective response rate (ORR) by blinded independent central review (BICR).
Primary Outcome
Pneumonitis included the MedDRA preferred terms for radiation pneumonitis are acute interstitial pneumonitis, autoimmune lung disease, interstitial lung disease, pneumonitis, idiopathic pneumonia syndrome, organizing pneumonia, and immune-mediated pneumonitis. As per common terminology criteria for Adverse Events, version 4.0, pneumonitis was graded as follows: Grade (Gr) 1- asymptomatic, clinical or diagnostic observations only; intervention not indicated; Gr 2- symptomatic, medical interventio
Interventions
- DRUG Pemetrexed 500 mg/m^2
- DRUG Pembrolizumab 200 mg
- DRUG Paclitaxel 45 mg/m^2
- DRUG Carboplatin AUC6
- DRUG Cisplatin 75 mg/m^2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2018-10-19 |
| Est. Completion | 2024-03-19 |
| Phase | Phase 2 |
What the finished NCT03631784 record still lists
NCT03631784 is an interventional study that assigns participants to a tested intervention. The registered 216 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 (62% higher).
The record links to 0 conditions, and to 5 interventions - of which Pemetrexed 500 mg/m^2 is the first listed.
NCT03631784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03631784 about?
NCT03631784 is a clinical study titled "A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)". This is a trial in adult participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC) treated with pembrolizumab in combination with platinum doublet chemotherapy and standard thoracic radiotherapy followed by pembrolizumab monotherapy. The primary hypothesis of the...
What is the current status of trial NCT03631784?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2018-10-19. Estimated completion is 2024-03-19.
What interventions are being tested in trial NCT03631784?
The interventions under investigation include: Pemetrexed 500 mg/m^2 (DRUG), Pembrolizumab 200 mg (DRUG), Paclitaxel 45 mg/m^2 (DRUG), Carboplatin AUC6 (DRUG), Cisplatin 75 mg/m^2 (DRUG).
Who is sponsoring clinical trial NCT03631784?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03631784's enrollment target sits among peer trials
216 286th of 2000 higher than 1,712 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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