Study With Various Immunotherapy Treatments in Participants With Lung Cancer

Sponsor: Gilead Sciences

Sponsor score: 60
Inactive

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.

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