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Chemotherapy

Immunotherapy Combinations for Lung Cancer (ARC-4 Trial)

Phase 1
Waitlist Available
Research Sponsored by Arcus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirm that an archival tissue sample is available and ≤ 24 months old; if not, a new biopsy of a tumor lesion should be obtained at screening
Adequate organ and marrow function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
Awards & highlights

ARC-4 Trial Summary

This trial is testing a new cancer drug to see if it is safe and effective. The drug will be given with or without another drug that is already approved to treat cancer.

Who is the study for?
This trial is for adults with advanced or recurrent non-squamous Non-Small Cell Lung Cancer (NSCLC) who have progressed on PD-1/-L1 therapy and haven't had chemotherapy. They must have a measurable lesion, good performance status, and no recent TKI therapy. Participants with specific genetic alterations in NSCLC who've exhausted targeted therapies can join but not those who've recently used certain drugs or have active autoimmune diseases.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of etrumadenant combined with carboplatin and pemetrexed, plus an anti-PD-1 antibody (pembrolizumab or zimberelimab), in treating NSCLC. It's an early-phase trial to find the right dose and see how well patients respond to this combination treatment.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the antibodies, fatigue, blood cell count changes leading to increased infection risk, organ function issues due to drug interactions, and potential complications from underlying health conditions.

ARC-4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a recent tissue sample from my tumor, not older than 24 months.
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My organs and bone marrow are working well.
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I haven't received any treatment for my condition and I refuse standard therapy.
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I have a genetic change in my cancer and have tried all targeted treatments available to me, but I haven't had chemotherapy or PD-1/-L1 therapy.
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My cancer progressed after PD-1/-L1 therapy and I've had less than 4 cycles of carboplatin/pemetrexed.
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I have not been treated for my condition and I refuse standard therapy.
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I have a genetic mutation in my cancer and have tried all targeted treatments available to me, but I haven't had chemotherapy or PD-1/PD-L1 therapy.
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It's been over 4 weeks since my last experimental treatment.
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I haven't taken any TKI therapy in the last 5 days.
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My cancer has worsened despite PD-1/-L1 therapy and I haven't had chemotherapy.
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I am 18 years old or older.
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My lung cancer is not squamous, has spread, and is getting worse.
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I've had treatments before and now have no other options for a cure.
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I am fully active or can carry out light work.
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I have tried many treatments and have no other options for a cure.
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My cancer has a specific mutation and didn't respond well to certain treatments.

ARC-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 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
Percentage of participants who experience a Dose Limiting Toxicity
Percentage of participants with Adverse Events
Secondary outcome measures
Duration of Response
Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months
Percentage of participants with Objective Response
+4 more

ARC-4 Trial Design

4Treatment groups
Experimental Treatment
Group I: Dose Expansion Arm 2Experimental Treatment4 Interventions
The etrumadenant at RDE determined from the dose escalation phase will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen and zimberelimab in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation.
Group II: Dose Expansion Arm 1Experimental Treatment3 Interventions
Zimberelimab will be administered in combination with standard carboplatin and pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer harboring a sensitizing EGFR mutation.
Group III: Dose Escalation Arm BExperimental Treatment4 Interventions
Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen and pembrolizumab in participants with Non-Small Cell Lung Cancer.
Group IV: Dose Escalation Arm AExperimental Treatment3 Interventions
Dose escalation is a 3+3 design, including a Dose Limiting Toxicity (DLT) evaluation period. The RDE of etrumadenant will be determined in this part with escalating doses of etrumadenant in combination with standard doses of carboplatin/pemetrexed chemotherapy regimen in participants with Non-Small Cell Lung Cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Zimberelimab
2018
Completed Phase 1
~50
Carboplatin
2014
Completed Phase 3
~6670
Etrumadenant
2018
Completed Phase 1
~130
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor
1,077 Previous Clinical Trials
836,873 Total Patients Enrolled
Arcus Biosciences, Inc.Lead Sponsor
41 Previous Clinical Trials
5,829 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences, Inc.
2,769 Previous Clinical Trials
8,062,123 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03846310 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Dose Expansion Arm 1, Dose Escalation Arm B, Dose Expansion Arm 2, Dose Escalation Arm A
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03846310 — Phase 1
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03846310 — Phase 1

Frequently Asked Questions

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

Are there any open vacancies for this research project?

"Clinicaltrials.gov doesn't display any new data suggesting that this trial is recruiting at the moment--it was initially posted on April 1st 2019 and last updated November 7th 2022. There are, however, 3643 other trials actively seeking participants right now."

Answered by AI

To what extent can Etrumadenant pose a hazard to individuals receiving treatment?

"The safety of Etrumadenant was rated a 1, as this is an early stage trial with minimal data confirming its efficacy and protection."

Answered by AI

What is the aggregate amount of individuals who are taking part in this research trial?

"At this time, no further candidates are required for the trial which was originally posted on April 1st 2019 and last edited November 7th 2022. There is a wealth of other studies looking for participants with lung cancer (2047) or Etrumadent (1596) currently recruiting."

Answered by AI

What medical applications does Etrumadenant typically have?

"Etrumadenant is commonly used to combat malignant neoplasms, but also can be efficacious for managing unresectable melanoma, microsatellite instability high, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

How many distinct sites are partaking in this experimental undertaking?

"Currently, 20 medical centres are accepting patients for this investigation. Examples of these include Medical Oncology Associates in Spokane, Florida Cancer Specialists & Research Institute in Tavares and Tennessee Oncology in Nashville - as well as an additional 17 sites."

Answered by AI

Are there any analogous studies which have used Etrumadenant in their methodology?

"Etrumadenant's initial research was conducted in the year 2002 at Bristol Royal Hospital for Children. In total, 1274 studies have been completed and 1596 are currently underway with a considerable portion of those trials taking place close to Spokane, Washington."

Answered by AI
~5 spots leftby Aug 2024