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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05676931
Recruitment Status : Recruiting
First Posted : January 9, 2023
Last Update Posted : May 2, 2024
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Arcus Biosciences, Inc.

Study Description
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Brief Summary:
The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.

Condition or disease Intervention/treatment Phase
Advanced Non-Small Cell Lung Cancer Drug: Domvanalimab Drug: Quemliclustat Drug: Zimberelimab Drug: Docetaxel Drug: Platinum-Based Doublet Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : February 1, 2023
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: A1: Domvanalimab + Zimberelimab
Domvanalimab and Zimberelimab, both administered by IV infusion
 Drug: Domvanalimab
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm
Experimental: A2: Domvanalimab + Zimberelimab
Domvanalimab and Zimberelimab, both administered by IV infusion
 Drug: Domvanalimab
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm
Experimental: A3: Quemliclustat + Zimberelimab
Quemliclustat and Zimberelimab, both administered by IV infusion
 Drug: Quemliclustat
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm
Experimental: B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
 Drug: Quemliclustat
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm

Drug: Platinum-Based Doublet
Administered as specified in the treatment arm
Experimental: B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
 Drug: Domvanalimab
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm

Drug: Platinum-Based Doublet
Administered as specified in the treatment arm
Experimental: B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
 Drug: Domvanalimab
Administered as specified in the treatment arm

Drug: Quemliclustat
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm

Drug: Platinum-Based Doublet
Administered as specified in the treatment arm
Experimental: C1: Quemliclustat + Zimberelimab + Docetaxel
Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion
 Drug: Quemliclustat
Administered as specified in the treatment arm

Drug: Zimberelimab
Administered as specified in the treatment arm

Drug: Docetaxel
Administered as specified in the treatment arm
Experimental: C2: Domvanalimab + Zimberelimab + Docetaxel
Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion
 Drug: Domvanalimab
Administered as specified in the treatment arm

Drug: Quemliclustat
Administered as specified in the treatment arm

Drug: Docetaxel
Administered as specified in the treatment arm


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: Up to 58 months ]
  2. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 58 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From date of first dose until the date of death due to any cause (approximately 58 months) ]
  2. Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1 [ Time Frame: Up to 58 months ]
  3. Disease Control Rate (DCR) [ Time Frame: Up to 58 months ]
  4. Duration of response (DoR) as determined by the Investigator according to RECIST v1.1 [ Time Frame: Up to 58 months ]
  5. Investigational study treatments peak plasma or serum concentration (Cmax) [ Time Frame: Up to 58 months ]
  6. Investigational study treatments time of peak concentration (Tmax) [ Time Frame: Up to 58 months ]
  7. Investigational study treatments area under the plasma or serum concentration versus time curve (AUC) [ Time Frame: Up to 58 months ]
  8. Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants [ Time Frame: Up to 58 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed, documented diagnosis of Stage IV metastatic, NSCLC
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
  • At least one measurable target lesion per RECIST v1.1.
  • Adequate organ and marrow function
  • Participants must be willing to provide adequate tumor tissue

Exclusion Criteria:

  • Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous
  • Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
  • 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).
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05676931


Contacts
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Contact: Arcus Biosciences +1-510-462-3330 ClinicalTrials@arcusbio.com

Locations
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Sponsors and Collaborators
Arcus Biosciences, Inc.
Gilead Sciences
Investigators
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Study Director: Medical Director Arcus Biosciences
More Information
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Responsible Party: Arcus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT05676931    
Other Study ID Numbers: EDGE-Lung
2022-502916-35-00 ( Other Identifier: CTIS )
First Posted: January 9, 2023    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
URL: https://trials.arcusbio.com/our-transparency-policy

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arcus Biosciences, Inc.:
Advanced Non-Small Cell Lung Cancer
Domvanalimab
Zimberelimab
 Quemliclustat
Anti-TIGIT antibody
Anti-PD-1 antibody
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Docetaxel
Quemliclustat
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immune Checkpoint Inhibitors
Antineoplastic Agents, Immunological