SC Pembrolizumab + Hyaluronidase for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two forms of the drug pembrolizumab for treating non-small cell lung cancer that has spread. Researchers aim to determine if a new version, administered as a shot under the skin (coformulated with hyaluronidase), is as effective as the standard IV version, both used alongside standard chemotherapy. The goal is to assess if the shot matches the effectiveness and safety of the IV form. Individuals newly diagnosed with this type of lung cancer who have not yet received treatment might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot have received certain cancer treatments or vaccines recently, and you cannot be on chronic steroid therapy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of pembrolizumab with hyaluronidase is generally well-tolerated. In earlier studies, side effects were similar to those observed when using pembrolizumab alone. Common side effects included fatigue and nausea.
Pembrolizumab, whether used alone or with hyaluronidase, maintains a safety profile similar to its traditional form. This indicates that adding hyaluronidase does not increase the risk of side effects.
For those considering joining a clinical trial, it's important to know that pembrolizumab is already used to treat other conditions, providing a known safety record. Always consult a healthcare professional to understand how this treatment might work for you.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer innovative approaches to treating non-small cell lung cancer (NSCLC). The first treatment combines pembrolizumab with berahyaluronidase alfa, delivered via subcutaneous injection, which could potentially enhance drug absorption and convenience compared to traditional intravenous administration. This method also incorporates platinum doublet chemotherapy, aiming to boost effectiveness in metastatic cases. The second approach uses pembrolizumab through intravenous infusion alongside platinum doublet chemotherapy, serving as an active comparator to assess the benefits of the new formulation. These treatments could provide new options for patients, potentially improving outcomes and quality of life.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
Research shows that both the under-the-skin (subcutaneous) and through-the-vein (intravenous) forms of pembrolizumab work well with chemotherapy to treat advanced non-small cell lung cancer (NSCLC). In this trial, participants in Arm 1 will receive the under-the-skin version, Pembrolizumab Formulated With Berahyaluronidase Alfa, combined with platinum doublet chemotherapy. Participants in Arm 2 will receive the through-the-vein version, pembrolizumab intravenous infusion, also with platinum doublet chemotherapy. Studies have found that the under-the-skin version moves through the body similarly to the through-the-vein version, suggesting they are likely equally effective. The trial aims to determine if the under-the-skin version can be administered more easily while still providing the same benefits. Pembrolizumab is already known to be an effective treatment for NSCLC, so this research focuses on the method of administration, not its efficacy.12456
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either subcutaneous pembrolizumab coformulated with hyaluronidase or intravenous pembrolizumab, administered with chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Pembrolizumab coformulated with hyaluronidase
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University