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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 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Awards & 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

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04925986 — Phase 2
Lung Disease Research Study Groups: Group 1A: PD-L1 1-49%, Main Study Population, Group 1B: PD-L1 1-49%, Pembrolizumab run-in population, Group 2A: PD-L1 ≥ 50%, Main Study Population, Group 2B: PD-L1 ≥ 50%, Pembrolizumab run-in population
Lung Disease Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04925986 — Phase 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04925986 — Phase 2
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