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PD-1 Inhibitor
Sitravatinib + Pembrolizumab for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Sarah Goldberg, MD MPH
Research Sponsored by Sarah Goldberg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new combination of drugs to treat non-squamous NSCLC that is positive for PD-L1.
Who is the study for?
Adults with advanced non-squamous PD-L1 positive NSCLC who haven't had systemic therapy for advanced disease. They must be willing to undergo a biopsy, use contraception if of childbearing potential, and have no major health issues that could interfere with the trial. Exclusions include autoimmune diseases within 2 years, other cancers, certain genetic mutations, recent major surgery or vaccines, serious heart conditions, uncontrolled infections like HIV or hepatitis C.
What is being tested?
The study is testing the combination of Sitravatinib and Pembrolizumab as a first-line treatment for lung cancer patients with PD-L1 mutation. It's a phase 2 trial assessing how effective this drug combo is in treating those who haven't received prior treatments for their advanced stage cancer.
What are the potential side effects?
Potential side effects may include immune system reactions leading to inflammation in various organs (like colitis or hepatitis), skin rashes, fatigue, changes in hormone levels affecting thyroid function among others. Specific side effects related to Sitravatinib might also occur but are not detailed here.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
Incidence of Adverse Events as per CTCAE v.5
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Group 2B: PD-L1 ≥ 50%, Pembrolizumab run-in populationExperimental Treatment2 Interventions
Participants with PD-L1 Tumor Proportion Score (TPS) ≥ 50% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Group II: Group 2A: PD-L1 ≥ 50%, Main Study PopulationExperimental Treatment2 Interventions
Participants with PD-L1 Tumor Proportion Score (TPS) ≥ 50% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Group III: Group 1B: PD-L1 1-49%, Pembrolizumab run-in populationExperimental Treatment2 Interventions
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Group IV: Group 1A: PD-L1 1-49%, Main Study PopulationExperimental Treatment2 Interventions
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sitravatinib
2017
Completed Phase 2
~510
Pembrolizumab
2017
Completed Phase 3
~2810
Find a Location
Who is running the clinical trial?
Sarah GoldbergLead Sponsor
Mirati Therapeutics Inc.Industry Sponsor
70 Previous Clinical Trials
8,120 Total Patients Enrolled
Sarah Goldberg, MD MPHPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have an autoimmune disease that has been active in the past 2 years, you cannot participate. However, if you have specific autoimmune conditions like type 1 diabetes, vitiligo, Graves' disease, or hypothyroidism that only need hormone replacement, you can still participate.You have another type of cancer that could be confused with the cancer being studied.You have specific mutations in your genes called EGFR, ROS1, ALK, or BRAF.You have received treatment with drugs that boost the immune system before.Women who could become pregnant must have a negative pregnancy test before joining the study.You have a specific type of lung cancer that has spread to other parts of the body or cannot be removed with surgery.You have already been treated with a medication that works in a similar way as sitravatinib.You had a very serious blood clot in the past 6 months. If you had a less serious blood clot, you can still participate as long as you are getting standard treatment.You have had unstable chest pain or congestive heart failure in the past 6 months, or certain heart rhythm or pumping problems. Your high blood pressure is not well controlled despite treatment.Your HIV is not under control. You may still be able to join the study if you meet certain requirements.You have an ongoing hepatitis C infection, but if you have completed treatment and have no detectable virus and normal liver function, you may be eligible.You had a stroke or mini-stroke in the last 6 months.You have had significant coughing up of blood or bleeding within 4 weeks before the study starts.You have a disease that can be measured using specific guidelines.Your PD-L1 levels are at least 1%, as tested in a certified lab.You have a good level of physical ability, with minimal to no impact on your daily activities.You are expected to live for at least 3 more months.You have leptomeningeal disease.You have brain tumors that are causing symptoms or haven't been treated, except in certain situations where they're stable and don't require strong medications.You have not had any previous treatments for advanced disease, except for chemotherapy for local or locally advanced disease completed more than 6 months ago. You have not had any prior immunotherapy.You have a weakened immune system due to a medical condition or medication, except for certain types of steroids used in specific ways.Your blood counts, liver function, and kidney function must be at certain levels to join the study.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1A: PD-L1 1-49%, Main Study Population
- Group 2: Group 1B: PD-L1 1-49%, Pembrolizumab run-in population
- Group 3: Group 2A: PD-L1 ≥ 50%, Main Study Population
- Group 4: Group 2B: PD-L1 ≥ 50%, Pembrolizumab run-in population
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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