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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 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 216 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03631784
The ClinicalTrials.gov registry entry for NCT03631784 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 216 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pemetrexed 500 mg/m^2 is the first listed.
NCT03631784 reports 0 study locations.
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.
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