Sacituzumab Tirumotecan + Pembrolizumab for Lung Cancer
(TroFuse-007 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you do not take strong inhibitors or inducers of CYP3A4 (a liver enzyme) at least 14 days before starting the study and throughout the study. If you are on such medications, you may need to stop or switch them.
What data supports the effectiveness of the drug Sacituzumab Tirumotecan + Pembrolizumab for lung cancer?
Pembrolizumab, a part of the treatment, has shown effectiveness in treating non-small cell lung cancer (NSCLC) by improving survival rates and slowing disease progression, as demonstrated in several clinical trials. It is approved for use in patients with certain types of lung cancer, showing significant benefits compared to traditional chemotherapy.12345
Is the combination of Sacituzumab Tirumotecan 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 immune-related side effects like type 1 diabetes and thyroid issues. The safety profile of pembrolizumab in combination with other drugs has been consistent with known safety data, but specific safety data for Sacituzumab Tirumotecan in combination with pembrolizumab is not provided in the available research.12346
What makes the drug Sacituzumab Tirumotecan + Pembrolizumab unique for lung cancer treatment?
What is the purpose of this trial?
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
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) showing high PD-L1 expression in tumors. Candidates must have a life expectancy of over 3 months, controlled HIV if present, and no need for EGFR-, ALK-, or ROS1-targeted primary therapy. They should be physically able to perform daily activities with little or no assistance.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sacituzumab tirumotecan and pembrolizumab or pembrolizumab alone for 18 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may receive up to an additional 9 cycles of pembrolizumab monotherapy if there is progressive disease
Treatment Details
Interventions
- MK-2870
- Pembrolizumab
MK-2870 is already approved in China for the following indications:
- Unresectable locally advanced or metastatic triple-negative breast cancer
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