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Anti-metabolites
Vudalimab or Pembrolizumab with Chemotherapy for Lung Cancer
Norwich, CT
Phase 1 & 2
Recruiting
Research Sponsored by Xencor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed, locally advanced (unresectable) or metastatic nonsquamous NSCLC
ECOG performance status score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to 2.5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find the right amount of vudalimab to use alongside chemotherapy for patients with a specific type of lung cancer. The study will also compare the effectiveness and safety of vud
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Who is the study for?
This trial is for adults with advanced non-squamous NSCLC who haven't had treatment before. They should not have certain gene mutations or a high PD-L1 level, and must be in good physical condition with a life expectancy of at least 3 months. Their liver, kidney, thyroid, and bone marrow must function well.Check my eligibility
What is being tested?
The study tests Vudalimab combined with chemotherapy (Carboplatin + Pemetrexed) against Pembrolizumab with the same chemo as first-line treatments. Part 1 determines the best dose of Vudalimab; Part 2 compares its effectiveness and safety to Pembrolizumab.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, nausea from chemotherapy drugs used alongside both Vudalimab and Pembrolizumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is advanced, cannot be surgically removed, and is not squamous type.
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I am fully active or can carry out light work.
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My cancer does not have certain genetic changes that can be treated with specific drugs.
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I haven't received any systemic treatment for advanced lung cancer.
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I'm sorry, but the term "Key" on its own is not clear enough for me to provide a simplified summary. If you could provide more context or clarify the term, I'd be happy to help!
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to 1.4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 1.4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1: Recommended Phase 2 dose of vudalimab in combination with chemotherapy
Part 2: Progression free survival
Secondary study objectives
Antitumor activity
Area Under the Concentration-time Curve (AUC)
Changes in circulating tumor DNA (ctDNA)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Vudalimab + Carboplatin + PemetrexedExperimental Treatment1 Intervention
Group II: Pembrolizumab + Carboplatin + PemetrexedActive Control1 Intervention
Find a Location
Closest Location:Eastern Connecticut Hematology and Oncology Associates· Norwich, CT
Who is running the clinical trial?
Xencor, Inc.Lead Sponsor
30 Previous Clinical Trials
2,484 Total Patients Enrolled
Jolene ShorrStudy DirectorExecutive Director, Clinical Development
2 Previous Clinical Trials
255 Total Patients Enrolled