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Chemotherapy

Immunotherapy Combinations for Non-Small Cell Lung Cancer (EDGE-Lung Trial)

Phase 2

Recruiting

Research Sponsored by Arcus Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed, documented diagnosis of Stage IV metastatic, NSCLC

Participants must be willing to provide adequate tumor tissue

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 58 months

Awards & highlights

EDGE-Lung Trial Summary

This trial will measure the effectiveness of a combination of drugs to fight cancer and how safe they are.

Who is the study for?

This trial is for adults with Stage IV metastatic non-small cell lung cancer (NSCLC) who have at least one measurable tumor and are in good physical condition (ECOG PS of 0 to 1). They must be able to provide a tissue sample and have their major organs functioning well. People with serious medical conditions, recent live vaccines, high-dose steroid or immunosuppressant use, psychiatric or substance abuse issues, or active autoimmune diseases can't participate.Check my eligibility

What is being tested?

The study tests combinations of new drugs Quemliclustat, Zimberelimab, Domvanalimab with standard treatments like Docetaxel and Platinum-Based Doublet chemotherapy. The goal is to see how well these combinations work against NSCLC by measuring the shrinkage of tumors and evaluating the safety and comfort level of these therapies.See study design

What are the potential side effects?

Possible side effects include immune system reactions that may affect different parts of the body leading to inflammation, fatigue from treatment-related stress on the body's systems, potential blood disorders due to bone marrow impact from chemotherapy agents used alongside immunotherapies.

EDGE-Lung Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is at stage IV and has spread to other parts.

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I am willing to provide samples of my tumor for testing.

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I can carry out all my daily activities without help.

EDGE-Lung Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 58 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 58 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 58 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Secondary outcome measures

Disease Control Rate (DCR)

Duration of response (DoR) as determined by the Investigator according to RECIST v1.1

Investigational study treatments area under the plasma or serum concentration versus time curve (AUC)

+5 more

EDGE-Lung Trial Design

8Treatment groups

Experimental Treatment

Group I: C2: Domvanalimab + Zimberelimab + DocetaxelExperimental Treatment4 Interventions

Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion

Group II: C1: Quemliclustat + Zimberelimab + DocetaxelExperimental Treatment3 Interventions

Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion

Group III: B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet ChemotherapyExperimental Treatment4 Interventions

Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion

Group IV: B2: Domvanalimab + Zimberelimab + Platinum Doublet ChemotherapyExperimental Treatment3 Interventions

Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion

Group V: B1: Quemliclustat + Zimberelimab + Platinum Doublet ChemotherapyExperimental Treatment3 Interventions

Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion

Group VI: A3: Quemliclustat + ZimberelimabExperimental Treatment2 Interventions

Quemliclustat and Zimberelimab, both administered by IV infusion

Group VII: A2: Domvanalimab + ZimberelimabExperimental Treatment2 Interventions

Domvanalimab and Zimberelimab, both administered by IV infusion

Group VIII: A1: Domvanalimab + ZimberelimabExperimental Treatment2 Interventions

Domvanalimab and Zimberelimab, both administered by IV infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Zimberelimab

2018

Completed Phase 1

~50

Docetaxel

1995

Completed Phase 4

~5620

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Lead Sponsor

41 Previous Clinical Trials

5,746 Total Patients Enrolled

Gilead SciencesIndustry Sponsor

1,084 Previous Clinical Trials

848,159 Total Patients Enrolled

Medical DirectorStudy DirectorArcus Biosciences

2,777 Previous Clinical Trials

8,063,420 Total Patients Enrolled

Media Library

Docetaxel (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05676931 — Phase 2

Non-Small Cell Lung Cancer Research Study Groups: C2: Domvanalimab + Zimberelimab + Docetaxel, A1: Domvanalimab + Zimberelimab, A2: Domvanalimab + Zimberelimab, A3: Quemliclustat + Zimberelimab, B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy, B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy, B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy, C1: Quemliclustat + Zimberelimab + Docetaxel

Non-Small Cell Lung Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT05676931 — Phase 2

Docetaxel (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05676931 — Phase 2

Frequently Asked Questions

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

What adverse effects might be experienced by patients taking A1: Domvanalimab + Zimberelimab?

"Our internal assessment of A1: Domvanalimab + Zimberelimab's safety is a 2—though there are some studies showing its security, efficacy remains untested."

Answered by AI

Does the research team require additional participants for this experiment?

"Affirmative. Clinicaltrials.gov presents the fact that this clinical trial is still actively recruiting patients, with an initial post date of January 1st 2023 and a most recent update on May 1st 2023. The study requires 320 participants across one medical centre to take part."

Answered by AI

How many participants have been enlisted in this clinical examination?

"Affirmative. The information found on clinicaltrials.gov affirms that this experiment is currently enrolling participants, and it was initially posted on January 1st 2023 with revisions made as recently as May 1st of the same year. This study requires 320 volunteers from a single site to be recruited for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer

2023. "Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05676931.

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