V940 + Pembrolizumab for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received certain cancer treatments or vaccines recently. It's best to discuss your current medications with the trial team.
Is the combination of V940 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 pneumonitis (lung inflammation). While specific safety data for the combination with V940 is not detailed, pembrolizumab's safety profile is well-documented in other conditions.12345
What makes the drug pembrolizumab unique for treating non-small cell lung cancer?
Pembrolizumab is unique because it is an immunotherapy drug that works by blocking the PD-1 pathway, helping the immune system attack cancer cells more effectively. It is used for patients whose tumors express PD-L1, and it has shown significant improvements in survival compared to traditional chemotherapy.12567
What data supports the effectiveness of the drug V940 + Pembrolizumab for Non-Small Cell Lung Cancer?
Who Is on the Research Team?
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Are You a Good Fit for This Trial?
This trial is for adults with resectable Stage II-III non-small cell lung cancer (NSCLC) who haven't had prior treatments and whose tumors didn't fully respond to initial therapy before surgery. They must be in good physical condition, not need EGFR-targeted primary therapy, and can have controlled hepatitis B or C or HIV.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive pembrolizumab and chemotherapy for up to 4 cycles before surgery
Surgical Resection
Participants undergo surgical resection of the tumor
Adjuvant Treatment
Participants receive pembrolizumab and V940 or placebo for up to 7 cycles post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- V940
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
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
ModernaTX, Inc.
Industry Sponsor
Dr. Stephen Hoge
ModernaTX, Inc.
Chief Medical Officer
MD from Harvard Medical School
Stéphane Bancel
ModernaTX, Inc.
Chief Executive Officer since 2011
MBA from Harvard Business School, MSc in Engineering from École Centrale Paris