Pembrolizumab for Advanced Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This single center open-label trial will enroll a single cohort of patients with advanced non-small cell lung cancer (NSCLC) who are ineligible for treatment with curative intent due to 1) disease stage IV, or 2) inability to tolerate intensive surgery or chemo-radiation. Patients will be eligible for the trial if ISMMS reviewed samples from tumor biopsy have a PDL-1 TPS ≥ 1% and have ECOG performance status rated 2 or 3. All patients will receive anti PD-1 therapy with pembrolizumab 200mg IV every 3 weeks, during which patients will also undergo serial QOL assessments.This trial will follow a phase II single arm, open label design. The study will enroll 45 patients evaluable for the primary endpoint of which will be change in QOL as measured by the EORTC's QLQ-C30 between Day 1 and Day 84 +/- 7 days. Secondary outcomes including evaluation for development of confounding mental health conditions will be evaluated via serial HADS assessments. Concomitant radiographic assessment with PET/CT, regardless of the doses of pembrolizumab received, will allow for evaluation of secondary efficacy outcomes, including disease response by RECIST 1.1 criteria.
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 medications for autoimmune conditions requiring more than 10mg of prednisone daily or other systemic immunosuppressive therapy, you may not be eligible to participate.
Is pembrolizumab safe for humans?
Pembrolizumab (also known as Keytruda or MK-3475) has been used in clinical trials for various cancers, including lung cancer and melanoma. Common side effects include fatigue, cough, nausea, and rash, while more serious immune-related side effects can include lung inflammation (pneumonitis), liver inflammation (hepatitis), and thyroid problems. These side effects are generally considered manageable, and the benefits of treatment often outweigh the risks for serious conditions.12345
What makes the drug pembrolizumab unique for treating advanced non-small cell lung cancer?
Pembrolizumab is unique because it is an immune checkpoint inhibitor that targets the PD-1/PD-L1 pathway, helping the immune system recognize and attack cancer cells. It is approved for patients with tumors expressing PD-L1 and has shown significant improvements in survival compared to traditional chemotherapy.24567
What data supports the effectiveness of the drug pembrolizumab for advanced non-small cell lung cancer?
Who Is on the Research Team?
Deborah Doroshow, MD, PhD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Bailey Fitzgerald, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
Adults with advanced non-small cell lung cancer (NSCLC) who can't have surgery or intense treatment, and haven't had systemic therapy for metastatic cancer. They must have a certain level of tumor protein (PDL-1 TPS ≥ 1%) and be physically able to take part in the study despite having an ECOG performance status of 2 or 3. Participants need functioning organs, controlled HIV if present, no recent brain metastases needing immediate treatment, and agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab 200mg IV every 3 weeks for 12 weeks, with serial QOL assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment, including QOL assessments and radiographic evaluations
Open-label extension (optional)
Participants may transition to pembrolizumab 400mg IV every 6 weeks until disease progression or unacceptable toxicity
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
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?
Icahn School of Medicine at Mount Sinai
Lead Sponsor