Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or have had recent chemotherapy or biological cancer therapy, you may need to stop or adjust those treatments before starting the trial.
What data supports the effectiveness of the drug Pembrolizumab combined with chemotherapy for non-small cell lung cancer?
Is the combination of Pembrolizumab and chemotherapy safe for humans?
Pembrolizumab, when used with chemotherapy, has been generally safe but can cause side effects like pneumonitis (lung inflammation) in 1%-5% of patients and rare cases of type 1 diabetes (a condition where the body can't produce insulin). These side effects are part of the immune-related adverse events that can occur with this treatment.15678
What makes the drug combination of Pembrolizumab and chemotherapy unique for treating non-small cell lung cancer?
This drug combination is unique because Pembrolizumab, an immune system booster, is used alongside chemotherapy to improve survival rates in non-small cell lung cancer patients compared to chemotherapy alone. Pembrolizumab targets the PD-1 pathway, enhancing the body's immune response against cancer cells.156910
What is the purpose of this trial?
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC.This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
This trial is for adults with advanced non-small cell lung cancer (NSCLC) who haven't had treatment before. They should not be eligible for approved targeted therapies, have good organ function, and agree to use contraception. Pregnant or breastfeeding individuals, those with certain heart conditions, active infections, recent major surgery or live vaccines are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab with or without chemotherapy in combination with investigational agents for up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Boserolimab
- Carboplatin
- MK-4830
- MK-5890
- Paclitaxel
- Pembrolizumab
- Pemetrexed
- Vibostolimab
Boserolimab is already approved in European Union, United States, Canada, Japan for the following indications:
- Melanoma
- Non-small cell lung cancer
- Head and neck cancer
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Endometrial carcinoma
- Melanoma
- Non-small cell lung cancer
- Head and neck cancer
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Endometrial carcinoma
- Esophageal carcinoma
- Cervical cancer
- Melanoma
- Non-small cell lung cancer
- Head and neck cancer
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Endometrial carcinoma
- Melanoma
- Non-small cell lung cancer
- Head and neck cancer
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
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
Daiichi Sankyo
Industry Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD