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Chemotherapy

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

Phase 2
Recruiting
Research Sponsored by Gilead Sciences
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
Must not have
Concurrent chronic medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids are not excluded)
Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking high doses of steroids or immunosuppressants for another health condition.
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I haven't needed systemic treatment for an autoimmune disease in the last 2 years, except for vitiligo or childhood asthma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Docetaxel
1995
Completed Phase 4
~6550
Quemliclustat
2020
Completed Phase 2
~180
Zimberelimab
2020
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Industry Sponsor
42 Previous Clinical Trials
6,766 Total Patients Enrolled
Gilead SciencesLead Sponsor
1,130 Previous Clinical Trials
866,807 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
358 Previous Clinical Trials
191,796 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
~202 spots leftby Dec 2027
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