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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: Active Phase 3 study of Metastatic Non Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
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 370-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented.
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 |
What the registry record for NCT05722015 still lists
NCT05722015 is an interventional study that assigns participants to a tested intervention. The registered 377 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 370-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target.
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 names 20 study sites across 15 states, led by 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.
Learn More About Clinical Trials
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Where NCT05722015's enrollment target sits among peer trials
377 15th of 31 higher than 17 of 31 other Metastatic Non Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Non Small Cell Lung Cancer 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.
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