Study With Various Immunotherapy Treatments in Participants With Lung Cancer

NCT05676931
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
400
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Lead sponsor
Gilead Sciences
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Start date
2023-02-21
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Number of sites
53
clinicaltrials.gov

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.
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Acronym
EDGE-Lung
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Short title
Study With Various Immunotherapy Treatments in Participants With Lung Cancer
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Official title
A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-12-01
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First posted
2023-01-09
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Registry last updated
2026-06-01
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Primary completion date
2027-12-01
clinicaltrials.gov
Start date
2023-02-21
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Participants
400
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Participant count basis
Estimated
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Planned participants
400
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Protocol amendments
5
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Number of sites
53
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Gilead Sciences
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05676931
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ClinicalTrials.gov ID
NCT05676931
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Registry record
Open registry record
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Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Timeframe: Up to 58 months

  2. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Timeframe: Up to 58 months

  1. Overall Survival (OS)

    Timeframe: 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

    Timeframe: Up to 58 months

  3. Disease Control Rate (DCR)

    Timeframe: Up to 58 months

  4. Duration of response (DoR) as determined by the Investigator according to RECIST v1.1

    Timeframe: Up to 58 months

  5. Investigational study treatments peak plasma or serum concentration (Cmax)

    Timeframe: Up to 58 months

  6. Investigational study treatments time of peak concentration (Tmax)

    Timeframe: Up to 58 months

  7. Investigational study treatments area under the plasma or serum concentration versus time curve (AUC)

    Timeframe: Up to 58 months

  8. Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants

    Timeframe: Up to 58 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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.

Sources for eligibility
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  • University of Alabama at Birmingham (UAB)Birmingham, United States
  • University of California San Diego (UCSD)La Jolla, United States
  • Memorial Cancer Institute at Memorial Regional HospitalHollywood, United States
  • Hematology Oncology Associates Of The Treasure CoastPort Saint Lucie, United States
  • Florida Cancer Specialists (Administration and Drug Shipment)The Villages, United States
  • Northwestern Memorial HospitalChicago, United States
  • Ochsner Clinic FoundationJefferson, United States
  • Henry Ford HospitalDetroit, United States
  • Virginia Cancer Specialists, PCFairfax, United States
  • Medical Oncology Associated, PS (dba Summit Cancer Centers)Spokane, United States
  • The Border Cancer HospitalAlbury, Australia
  • Pindara Private HospitalBenowa, Australia
  • Cancer Research SA Pty LtdAdelaide, Australia
  • Sir Charles Gairdner HospitalNedlands, Australia
  • CHU Bordeaux Centre Francois Magendie Hôpital du Haut LévèqueBordeaux, France
  • Hospices Civils de Lyon Centre Hospitalier Lyon SudLyon, France
  • Institut De Cancerologie Strasbourg Europe ICANSStrasboug, France
  • Hopital FOCHSuresnes, France
  • LTD High Technology Hospital MedcenterBatumi, Georgia
  • Caucasus Medical CenterTbilisi, Georgia
  • Israel Georgian Medical Research Clinic HealthycoreTbilisi, Georgia
  • JSC K. Eristavi National Center of Experimental and Clinical SurgeryTbilisi, Georgia
  • Ltd Pineo Medical EcosystemTbilisi, Georgia
  • Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRSTMeldola, Italy
  • stituto Nazionale per lo Studio e la Cura dei TumoriMilan, Italy

And 28 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2022-502916-35-01
Sources for references
clinicaltrials.gov

Related records

Drugs (5)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (17)