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OpenTrials
Active, Not Recruiting

NCT Number: NCT05676931

Study With Various Immunotherapy Treatments in Participants With Lung Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Border Cancer Hospital, Albury, New South Wales, Australia

Loading trial locations.

About this study

The study includes multiple substudy arms (Substudy A, B, C), which will evaluate immunotherapy-based combinations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically documented 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 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).
  • Use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications ≤ 14 days before the initiation of study treatment (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.

Treatment and study plan

Domvanalimab

Drug

Administered as specified in the treatment arm

Quemliclustat

Drug

Administered as specified in the treatment arm

Zimberelimab

Drug

Administered as specified in the treatment arm

docetaxel

Drug

Administered as specified in the treatment arm

Platinum-Based Doublet

Drug

Administered as specified in the treatment arm

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Arcus Biosciences, Inc.

Registry information

Official study title

A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer

Acronym: EDGE-Lung

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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