A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50% or Greater

New subcutaneous pembrolizumab option for advanced lung cancer tested in Phase 3 trial

NCT: NCT06698042 · Status: ACTIVE NOT RECRUITING · Phase: Phase 3 · Sponsor: Merck Sharp & Dohme LLC · Started: 2024-11-21 · Est. Completion: 2030-02-11

Plain English Summary

A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84) is a Phase 3 clinical trial sponsored by Merck Sharp & Dohme LLC studying Lung Cancer, Non-Small Cell Lung Cancer. This study tests a new way to give pembrolizumab, an immunotherapy drug, as an under-the-skin injection instead of an IV infusion. It is for adults newly diagnosed with advanced non-small cell lung cancer that has spread and has specific markers (PD-L1 TPS 50% or greater). Participants will receive either the new under-the-skin injection or the standard IV infusion of pembrolizumab, and will be closely monitored. The current standard treatment is pembrolizumab given through an IV infusion. The trial aims to enroll 67 participants.

Official Summary

Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body. Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to learn what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you have been diagnosed with non-small cell lung cancer that has spread and has specific PD-L1 markers. You cannot join if you have small cell lung cancer, have had prior treatment for your advanced lung cancer, or have active autoimmune disease or certain lung conditions. Age is not specified, but the trial is for adults. You must have measurable disease and not have active infections or certain other medical conditions. This trial is studying Lung Cancer, Non-Small Cell Lung Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The study will measure how much of the drug is in your body over time to ensure the new under-the-skin injection works as well as the IV infusion. The specific primary outcome measures are: Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose (At designated time points (up to approximately 14 months)); Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State (At designated time points (Up to ~15 months)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial matters because it explores a more convenient way to administer pembrolizumab, potentially improving patient experience and accessibility for treating advanced lung cancer. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Lung Cancer, Non-Small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial investigates a subcutaneous formulation of a widely used immunotherapy, potentially offering a more convenient administration route and expanding market reach for pembrolizumab in a large o Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for you and what the potential benefits and risks are. Understand that you will receive either the new under-the-skin injection or the standard IV infusion, and you will need to attend regular appointments for treatment and monitoring. Be prepared for potential side effects and discuss any concerns with your healthcare team. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
* Measurable disease as assessed by the local site investigator/radiology.

Exclusion Criteria:

* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
* Received prior systemic anticancer therapy for their metastatic NSCLC.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06698042?

NCT06698042 is a Phase 3 INTERVENTIONAL study titled "A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)." It is currently active, not recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 67 participants.

What conditions does NCT06698042 study?

This trial investigates treatments for Lung Cancer, Non-Small Cell Lung Cancer. The primary condition under study is Lung Cancer.

What treatments are being tested in NCT06698042?

The interventions being studied include: Pembrolizumab (+) Berahyaluronidase alfa (BIOLOGICAL), Pembrolizumab (BIOLOGICAL). Administered subcutaneously on Day 1 of each cycle

What does Phase 3 mean for NCT06698042?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06698042?

This trial is currently "Active, Not Recruiting." It started on 2024-11-21. The estimated completion date is 2030-02-11.

Who is sponsoring NCT06698042?

NCT06698042 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06698042?

The trial aims to enroll 67 participants. The trial status is active, not recruiting.

How is NCT06698042 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT06698042?

The primary outcome measures are: Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose (At designated time points (up to approximately 14 months)); Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State (At designated time points (Up to ~15 months)). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06698042 being conducted?

This trial is being conducted at 20 sites, including Fullerton, California; Peoria, Illinois; The Bronx, New York; Cincinnati, Ohio and 16 more sites (United States, China).

Where can I find official information about NCT06698042?

The official record for NCT06698042 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06698042. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06698042 testing in simple terms?

This study tests a new way to give pembrolizumab, an immunotherapy drug, as an under-the-skin injection instead of an IV infusion. It is for adults newly diagnosed with advanced non-small cell lung cancer that has spread and has specific markers (PD-L1 TPS 50% or greater).

Why is this trial significant?

This trial matters because it explores a more convenient way to administer pembrolizumab, potentially improving patient experience and accessibility for treating advanced lung cancer. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06698042?

Common side effects of pembrolizumab can include fatigue, rash, and diarrhea. Specific risks related to the subcutaneous injection may include injection site reactions like redness or swelling. The study will monitor for any new or worsening side effects, including immune-related reactions. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06698042?

Ask your doctor if this trial is a good fit for you and what the potential benefits and risks are. Understand that you will receive either the new under-the-skin injection or the standard IV infusion, and you will need to attend regular appointments for treatment and monitoring. Be prepared for potential side effects and discuss any concerns with your healthcare team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06698042 signal from an investment perspective?

This trial investigates a subcutaneous formulation of a widely used immunotherapy, potentially offering a more convenient administration route and expanding market reach for pembrolizumab in a large o This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will receive either the new under-the-skin injection or the standard IV infusion of pembrolizumab, and will be closely monitored. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More Lung Cancer Trials

View all Lung Cancer clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.