NC318 + Pembrolizumab for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new drug, NC318, alone or with Pembrolizumab, in patients with advanced lung cancer. It aims to help those who haven't responded to other treatments or have specific tumor characteristics. The drugs work by enhancing the immune system's ability to attack cancer cells.
Will I have to stop taking my current medications?
The trial requires that you stop taking systemic immunosuppressive medications (like certain steroids and drugs that suppress the immune system) at least 2 weeks before starting the trial. However, inhaled or topical steroids and standard-dose NSAIDs are allowed.
Is the combination of NC318 and Pembrolizumab safe for humans?
Pembrolizumab (also known as Keytruda) has been used in various cancer treatments and is generally considered safe, but it can cause side effects like fatigue, cough, nausea, and more serious immune-related issues like lung inflammation (pneumonitis) and liver inflammation (hepatitis). While specific safety data for the combination with NC318 is not provided, pembrolizumab's safety profile is well-documented in other conditions.12345
What makes the drug combination of NC318 and pembrolizumab unique for lung cancer treatment?
The combination of NC318 and pembrolizumab is unique because it involves using pembrolizumab, a drug that blocks a pathway (PD-1/PD-L1) to help the immune system attack cancer cells, alongside NC318, which may target different aspects of the tumor environment, potentially enhancing the overall treatment effect for lung cancer.23567
What data supports the effectiveness of the drug pembrolizumab for lung cancer?
Who Is on the Research Team?
Scott N. Gettinger
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for adults with advanced non-small cell lung cancer who have tried PD-1 axis inhibitor therapy and it didn't work (except Arm 2a). They should be relatively healthy, able to undergo a biopsy, and not have used immunosuppressive drugs recently. Those with certain gene mutations after treatment failure or intolerance are also eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
Initial safety assessment of NC318 alone or in combination with pembrolizumab
Treatment
Participants receive NC318 alone or in combination with pembrolizumab, with tumor assessments every 8 weeks for the first 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments every 12 weeks until disease progression
What Are the Treatments Tested in This Trial?
Interventions
- NC318
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
NextCure, Inc.
Industry Sponsor
Merck Sharp & Dohme LLC
Industry 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