SC Pembrolizumab + Hyaluronidase for Non-Small Cell Lung Cancer

Recruiting in Palo Alto (17 mi)

+109 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Merck Sharp & Dohme LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial compares two methods of administering a cancer drug in adults with advanced lung cancer. It aims to see if injecting the drug under the skin is as effective as giving it directly into a vein. The drug helps the immune system attack cancer cells by blocking a specific protein.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

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

Has a life expectancy of at least 3 months.

My lung cancer is confirmed as NSCLC through tests.

I can provide a sample of my tumor that hasn't been treated with radiation.

Exclusion Criteria

I have another cancer that is getting worse or was treated in the last 3 years.

I am currently being treated for an infection.

I have not had cancer treatment or been in a cancer study in the last 4 weeks.

Treatment Details

Interventions

• Pembrolizumab (PD-1 Inhibitor)
• Pembrolizumab coformulated with hyaluronidase (PD-1 Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Arm 1 (Pembrolizumab (+) Berahyaluronidase alfa+ Platinum Doublet Chemotherapy) Experimental Treatment 8 Interventions

Participants with treatment-naïve metastatic NSCLC will receive pembrolizumab (+) berahyaluronidase alfa SC in combination with platinum doublet chemotherapy.

Group II: Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy) Active Control 8 Interventions

Participants with treatment-naïve metastatic NSCLC will receive Pembrolizumab IV in combination with platinum doublet chemotherapy.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

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