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PD-1 Inhibitor

SC Pembrolizumab + Hyaluronidase for Non-Small Cell Lung Cancer

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC).
Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to~60 months
Awards & highlights

Study Summary

This trial will compare SC MK-3475A to IV pembrolizumab as first-line treatment for metastatic non-small cell lung cancer, assessing safety & how drugs are processed by the body.

Who is the study for?
Adults with metastatic non-small cell lung cancer (NSCLC) who have not had previous systemic anticancer treatments for metastatic disease. Participants must have a life expectancy of at least 3 months and be able to provide a tumor tissue sample. They cannot join if they've had certain other cancers, immunodeficiency, major surgery complications, or active infections.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Pembrolizumab given subcutaneously (under the skin) coformulated with hyaluronidase versus intravenously (into a vein), alongside chemotherapy in first-line treatment for NSCLC. The main goal is to compare how the body processes both forms of Pembrolizumab.See study design
What are the potential side effects?
Possible side effects include reactions at injection sites, fatigue, nausea from chemotherapy drugs like Paclitaxel and Cisplatin, lowered blood counts leading to increased infection risk or bleeding problems, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer is confirmed as NSCLC through tests.
Select...
I can provide a sample of my tumor that hasn't been treated with radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to~60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State
Secondary outcome measures
Area Under the Curve (AUC) of Pembrolizumab Measured at Steady State
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score-Items 29 and 30
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Physical Functioning Score-Items 1 to 5
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)Experimental Treatment8 Interventions
Participants with treatment-naïve metastatic NSCLC will receive MK 3475A SC in combination with platinum doublet chemotherapy.
Group II: Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)Active Control8 Interventions
Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
2000
Completed Phase 3
~3670
Nab-paclitaxel
2014
Completed Phase 3
~2030
Paclitaxel
2011
Completed Phase 4
~5380
Pemetrexed
2014
Completed Phase 3
~5250
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,322 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,061,822 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05722015 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm 1 (MK-3475A + Platinum Doublet Chemotherapy), Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)
Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05722015 — Phase 3
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05722015 — Phase 3
Non-Small Cell Lung Cancer Patient Testimony for trial: Trial Name: NCT05722015 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of MK-3475A and Platinum Doublet Chemotherapy been granted endorsement by the FDA?

"Our evaluation at Power concluded that Arm 1 (MK-3475A + Platinum Doublet Chemotherapy) is safe, scoring it a 3 on our scale. This comes from the evidence gathered in Phase 3 trials of efficacy and safety data."

Answered by AI

What is the aggregate number of individuals enrolled in this experiment?

"This study necessitates the enrolment of 339 individuals who meet its criteria for inclusion. Patients can take part from sites such as Mid Florida Hematology and Oncology Center (Site 0010) in Orange City, Florida or Changhua Christian Hospital ( Site 4203) in Changhua County, Changhua."

Answered by AI

Is this investigation still enrolling participants?

"Clinicaltrials.gov provides evidence that this medical trial is currently enrolling patients. The initial posting was made on February 14th 2023 and the details were last modified two weeks later, on February 28th 2023."

Answered by AI

What objectives is this experiment attempting to accomplish?

"This trial will measure the Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State for up to 27 months. Secondary desired outcomes include Progression-free Survival (PFS), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event, and Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs)."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
Hattiesburg Clinic Hematology/Oncology ( Site 0008)
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Ready to find a treatment for a cure and I really want to be outside of mobile for treatment options.
PatientReceived 1 prior treatment
~99 spots leftby Sep 2024