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NCT04956692 · ClinicalTrials.gov registry record · Phase 3
Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 531
- Enrollment target
- 20
- Study locations
NCT04956692: Active Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Merck Sharp & Dohme.
NCT04956692 is a Phase 3 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 531 participants, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04956692, a Phase 3 study of 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
- 531 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state. Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.
Primary Outcome
Cycle 1 AUC0-3wks is defined as the area under the concentration-time curve for pembrolizumab in plasma over a 3-week dosing interval in Cycle 1. Each cycle is 21 days.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Nab-Paclitaxel
- BIOLOGICAL Pembrolizumab SC
- BIOLOGICAL Pembrolizumab IV
Study Locations (20)
California
- St Joseph Heritage Healthcare-Oncology ( Site 0102) - Fullerton
- Cancer Blood and Specialty Clinic ( Site 0105) - Los Alamitos
- PIH Health Hematology Medical Oncology ( Site 0106) - Whittier
Florida
- Holy Cross Hospital ( Site 0017) - Fort Lauderdale
- Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104) - Hollywood
- Advent Health ( Site 0013) - Orlando
Tennessee
- The University of Tennessee Medical Center ( Site 0050) - Knoxville
- Tennessee Oncology ( Site 0051) - Nashville
Texas
- Oncology Consultants, PA ( Site 0052) - Houston
- Millennium Physicians - Oncology ( Site 0097) - Houston
Arkansas
- St. Bernards Medical Center ( Site 0103) - Jonesboro
Indiana
- Fort Wayne Medical Oncology and Hematology ( Site 0101) - Fort Wayne
Kentucky
- Baptist Health Lexington ( Site 0099) - Lexington
Missouri
- St Luke's Hospital - Kansas City ( Site 0033) - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 531 participants |
| Start Date | 2021-08-05 |
| Est. Completion | 2026-10-14 |
| Phase | Phase 3 |
What the registry record for NCT04956692 still lists
NCT04956692 is an interventional study that assigns participants to a tested intervention. The registered 531 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (18% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04956692 names 20 study sites across 14 states, led by California, Florida, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04956692 about?
NCT04956692 is a clinical study titled "Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)". The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with sta...
What is the current status of trial NCT04956692?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 531 participants. The study started on 2021-08-05. Estimated completion is 2026-10-14.
What conditions does trial NCT04956692 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT04956692?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Nab-Paclitaxel (DRUG), Pembrolizumab SC (BIOLOGICAL), Pembrolizumab IV (BIOLOGICAL).
Who is sponsoring clinical trial NCT04956692?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04956692 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04956692's enrollment target sits among peer trials
531 70th of 454 higher than 385 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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