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Anti-metabolites

Vudalimab or Pembrolizumab with Chemotherapy for Lung Cancer

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

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.
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.
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 below
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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!

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 1.4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 1.4 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
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 more

Awards & 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

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor
30 Previous Clinical Trials
2,600 Total Patients Enrolled
Jolene ShorrStudy DirectorExecutive Director, Clinical Development
2 Previous Clinical Trials
255 Total Patients Enrolled
~112 spots leftby Oct 2026