377 Participants Needed

SC Pembrolizumab + Hyaluronidase for Non-Small Cell Lung Cancer

Recruiting at 109 trial locations
TF
Overseen ByToll Free Number
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

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.

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.

What makes the drug pembrolizumab coformulated with hyaluronidase unique for non-small cell lung cancer?

This treatment combines pembrolizumab, an immune-boosting drug, with hyaluronidase, which helps the drug spread more easily in the body, potentially allowing for more effective delivery and absorption compared to standard pembrolizumab alone.12345

Who Is on the Research Team?

MD

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

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.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either subcutaneous pembrolizumab coformulated with hyaluronidase or intravenous pembrolizumab, administered with chemotherapy

Up to 25 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • Pembrolizumab coformulated with hyaluronidase
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet ChemotherapyExperimental Treatment8 Interventions
Group II: Arm 2: Pembrolizumab + Platinum Doublet ChemotherapyActive Control8 Interventions

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

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Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Published Research Related to This Trial

In a Phase 2 study involving 35 patients with non-small cell lung cancer, neoadjuvant pembrolizumab was found to be safe and well tolerated, with only one surgery delay due to thyroiditis and no mortality within 90 days post-surgery.
The study showed a high rate of R0 resection (88%) and a major pathologic response in 28% of patients, indicating that pembrolizumab may be more effective than standard neoadjuvant chemotherapy in this setting.
Perioperative outcomes of pulmonary resection after neoadjuvant pembrolizumab in patients with non-small cell lung cancer.Tong, BC., Gu, L., Wang, X., et al.[2022]
Pembrolizumab, a monoclonal antibody targeting PD-1, has shown significant efficacy in treating advanced non-small-cell lung cancer (NSCLC) across multiple clinical trials, particularly in patients with PD-L1 expression levels of 1% or higher.
The KEYNOTE studies identified specific patient populations that benefit most from pembrolizumab, highlighting the importance of PD-L1 as a companion diagnostic, while future research will explore its role in earlier stages of cancer treatment and in combination therapies.
Pembrolizumab in lung cancer: current evidence and future perspectives.Palumbo, G., Carillio, G., Manzo, A., et al.[2020]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

Citations

Perioperative outcomes of pulmonary resection after neoadjuvant pembrolizumab in patients with non-small cell lung cancer. [2022]
Pembrolizumab in lung cancer: current evidence and future perspectives. [2020]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. [2017]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
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