Study With Various Immunotherapy Treatments in Participants With Lung Cancer

Sponsor: Gilead Sciences

Sponsor score: 60

ClinicalTrials ID:NCT05676931

This study evaluates the objective response rate and safety of immunotherapy combinations in Stage IV NSCLC patients. Eligible participants must have an ECOG PS of 0-1, measurable lesions, and adequate organ function. Interventions include Domvanalimab, Quemliclustat, Zimberelimab, Docetaxel, and a Platinum-Based Doublet, administered per treatment arm specifications.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham (UAB)35294BirminghamAlabama
University of California San Diego (UCSD)92093La JollaCalifornia
Memorial Cancer Institute at Memorial Regional Hospital33021HollywoodFlorida
Hematology Oncology Associates Of The Treasure Coast34952Port Saint LucieFlorida
Florida Cancer Specialists (Administration and Drug Shipment)34232SarasotaFlorida
Florida Cancer Specialists32308TallahasseeFlorida
Florida Cancer Specialists (Administration and Drug Shipment)32163The VillagesFlorida
Northwestern Memorial Hospital60611ChicagoIllinois
Ochsner Clinic Foundation70121JeffersonLouisiana
Henry Ford Hospital48202DetroitMichigan

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