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NCT05722015 · ClinicalTrials.gov registry record · Phase 3
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)
A Phase 3 study of Metastatic Non Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 377
- Enrollment target
- 20
- Study locations
NCT05722015 is a Phase 3 study of Metastatic Non Small Cell Lung Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 377 participants, roughly in line with the 381-participant average among 30 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 15 states.
The verdict
NCT05722015, a Phase 3 study of Metastatic Non Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 377 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Paclitaxel
- BIOLOGICAL Pembrolizumab Formulated with Berahyaluronidase Alfa
Study Locations (20)
Buenos Aires F.D.
- Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002) - Buenos Aires
- Instituto Alexander Fleming ( Site 1008) - Buenos Aires
- Clinica Adventista Belgrano-Oncology ( Site 1004) - Buenos Aires
Florida
- Clermont Oncology Center ( Site 0018) - Clermont
- Mid Florida Hematology and Oncology Center ( Site 0010) - Orange City
Illinois
- University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022) - Chicago
- Orchard Healthcare Research Inc. ( Site 0011) - Skokie
Buenos Aires
- Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005) - Ciudad Autonoma de Buenos Aires
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001) - Mar del Plata
Arizona
- St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023) - Phoenix
Indiana
- Franciscan Health Lafayette East ( Site 0020) - Lafayette
Kentucky
- Mercy Health-Paducah Cancer Center ( Site 0006) - Paducah
Mississippi
- Hattiesburg Clinic Hematology/Oncology ( Site 0008) - Hattiesburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 377 participants |
| Start Date | 2023-02-14 |
| Est. Completion | 2028-05-22 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05722015
The ClinicalTrials.gov registry entry for NCT05722015 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 377 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 381-participant average among 30 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT05722015 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Buenos Aires F.D., Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05722015 about?
NCT05722015 is a clinical study titled "A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)". This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung ca...
What is the current status of trial NCT05722015?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 377 participants. The study started on 2023-02-14. Estimated completion is 2028-05-22.
What conditions does trial NCT05722015 study?
This clinical trial studies the following conditions: Metastatic Non Small Cell Lung Cancer.
What interventions are being tested in trial NCT05722015?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Paclitaxel (DRUG), Pembrolizumab Formulated with Berahyaluronidase Alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT05722015?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05722015 being conducted?
This trial has 20 study locations across Arizona, Florida, Illinois, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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