Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Advanced Non-Small Cell Lung Cancer, Domvanalimab, Zimberelimab, Quemliclustat, Anti-TIGIT antibody, Anti-PD-1 antibody, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Docetaxel, Platinum-Based Doublet, A1: Domvanalimab + Zimberelimab, A2: Domvanalimab + Zimberelimab, A3: Quemliclustat + Zimberelimab, B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy, B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy, B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy, C1: Quemliclustat + Zimberelimab + Docetaxel, C2: Domvanalimab + Zimberelimab + Docetaxel

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • University of California San Diego (UCSD) accepting new patients
    La Jolla California 92093 United States
  • Medical Oncology Associated, PS (dba Summit Cancer Centers) accepting new patients
    Spokane Washington 99208 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT05676931
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 320 study participants
Last Updated