GT103 + Pembrolizumab for Lung Cancer
Trial Summary
What is the purpose of this trial?
This trial tests the safety and tolerability of combining GT103, a new drug, with pembrolizumab, an immune-boosting cancer treatment, in adults with advanced lung cancer that has returned or not responded to previous treatments. Pembrolizumab is an immune-boosting treatment that has shown effectiveness in patients with lung cancer and has been tested with other treatments.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot be on certain anticancer therapies or medications that suppress the immune system beyond a certain level. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug pembrolizumab for lung cancer?
Is the combination of GT103 and Pembrolizumab safe for treating lung cancer?
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, and nausea. Serious side effects, such as pneumonitis (lung inflammation), occur in a small percentage of patients. Always discuss potential risks with your healthcare provider.15678
What makes the GT103 + Pembrolizumab treatment for lung cancer unique?
The combination of GT103 with Pembrolizumab is unique because Pembrolizumab is a PD-1 inhibitor that helps the immune system attack cancer cells, and it has shown significant efficacy in treating non-small cell lung cancer. This combination may offer a novel approach by potentially enhancing the immune response against lung cancer compared to using Pembrolizumab alone.125910
Research Team
Jeffrey M. Clarke
Principal Investigator
Duke Cancer Institute
Eligibility Criteria
Adults over 18 with Stage III-IV recurrent or metastatic NSCLC, who have relapsed or are refractory to immunotherapy and possibly chemotherapy. They must have adequate organ function, not be pregnant or breastfeeding, use contraception if of childbearing potential, and cannot have other conditions that might interfere with the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Safety Lead-in
A safety lead-in phase to determine the safest dose of GT103 in combination with pembrolizumab
Treatment
Participants receive GT103 and pembrolizumab intravenously on Day 1 of a 21-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- GT103
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jeffrey Clarke
Lead 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
Grid Therapeutics
Collaborator