The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE December 9, 2022
First Posted Date  ICMJE January 9, 2023
Last Update Posted Date May 2, 2024
Actual Study Start Date  ICMJE February 1, 2023
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2023)
  • Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) [ Time Frame: Up to 58 months ]
  • The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 58 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2023)
  • Overall Survival (OS) [ Time Frame: From date of first dose until the date of death due to any cause (approximately 58 months) ]
  • Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1 [ Time Frame: Up to 58 months ]
  • Disease Control Rate (DCR) [ Time Frame: Up to 58 months ]
  • Duration of response (DoR) as determined by the Investigator according to RECIST v1.1 [ Time Frame: Up to 58 months ]
  • Investigational study treatments peak plasma or serum concentration (Cmax) [ Time Frame: Up to 58 months ]
  • Investigational study treatments time of peak concentration (Tmax) [ Time Frame: Up to 58 months ]
  • Investigational study treatments area under the plasma or serum concentration versus time curve (AUC) [ Time Frame: Up to 58 months ]
  • Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants [ Time Frame: Up to 58 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer
Official Title  ICMJE A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Non-Small Cell Lung Cancer
Intervention  ICMJE
  • 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: Docetaxel
    Administered as specified in the treatment arm
  • Drug: Platinum-Based Doublet
    Administered as specified in the treatment arm
Study Arms  ICMJE
  • Experimental: A1: Domvanalimab + Zimberelimab
    Domvanalimab and Zimberelimab, both administered by IV infusion
    Interventions:
    • Drug: Domvanalimab
    • Drug: Zimberelimab
  • Experimental: A2: Domvanalimab + Zimberelimab
    Domvanalimab and Zimberelimab, both administered by IV infusion
    Interventions:
    • Drug: Domvanalimab
    • Drug: Zimberelimab
  • Experimental: A3: Quemliclustat + Zimberelimab
    Quemliclustat and Zimberelimab, both administered by IV infusion
    Interventions:
    • Drug: Quemliclustat
    • Drug: Zimberelimab
  • Experimental: B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
    Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
    Interventions:
    • Drug: Quemliclustat
    • Drug: Zimberelimab
    • Drug: Platinum-Based Doublet
  • Experimental: B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
    Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
    Interventions:
    • Drug: Domvanalimab
    • Drug: Zimberelimab
    • Drug: Platinum-Based Doublet
  • Experimental: B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
    Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
    Interventions:
    • Drug: Domvanalimab
    • Drug: Quemliclustat
    • Drug: Zimberelimab
    • Drug: Platinum-Based Doublet
  • Experimental: C1: Quemliclustat + Zimberelimab + Docetaxel
    Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion
    Interventions:
    • Drug: Quemliclustat
    • Drug: Zimberelimab
    • Drug: Docetaxel
  • Experimental: C2: Domvanalimab + Zimberelimab + Docetaxel
    Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion
    Interventions:
    • Drug: Domvanalimab
    • Drug: Quemliclustat
    • Drug: Docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 5, 2023)		 320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2026
Estimated Primary Completion Date September 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arcus Biosciences +1-510-462-3330 ClinicalTrials@arcusbio.com
Listed Location Countries  ICMJE Australia,   Korea, Republic of,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05676931
Other Study ID Numbers  ICMJE EDGE-Lung
2022-502916-35-00 ( Other Identifier: CTIS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
URL: https://trials.arcusbio.com/our-transparency-policy
Current Responsible Party Arcus Biosciences, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Arcus Biosciences, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Gilead Sciences
Investigators  ICMJE
Study Director: Medical Director Arcus Biosciences
PRS Account Arcus Biosciences, Inc.
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP