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Anti-metabolites

Vudalimab + Carboplatin + Pemetrexed for Non-Small Cell 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

Study 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.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 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 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 1.4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Recommended Phase 2 dose of vudalimab in combination with chemotherapy

Part 2: Progression free survival

Secondary outcome measures

Antitumor activity

Area Under the Concentration-time Curve (AUC)

Changes in circulating tumor DNA (ctDNA)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vudalimab + Carboplatin + PemetrexedExperimental Treatment1 Intervention

Group II: Pembrolizumab + Carboplatin + PemetrexedActive Control1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor

29 Previous Clinical Trials

2,585 Total Patients Enrolled

Jolene ShorrStudy DirectorExecutive Director, Clinical Development

1 Previous Clinical Trials

85 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants still able to apply for enrollment in this ongoing research study?

"Indeed, clinicaltrials.gov indicates that this trial is presently in search of eligible participants. The initial posting date for the trial was December 27th, 2023, and it received its most recent update on January 12th, 2024."

Answered by AI

What is the current number of participants being recruited for this research study?

"Indeed, information from clinicaltrials.gov confirms that this study is actively seeking eligible participants. The trial was initially posted on December 27th, 2023 and most recently updated on January 12th, 2024. A total of 168 individuals will be enrolled in the trial across two distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC

2023. "Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06173505.

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