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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham (UAB) | 35294 | Birmingham | Alabama |
| University of California San Diego (UCSD) | 92093 | La Jolla | California |
| Memorial Cancer Institute at Memorial Regional Hospital | 33021 | Hollywood | Florida |
| Hematology Oncology Associates Of The Treasure Coast | 34952 | Port Saint Lucie | Florida |
| Florida Cancer Specialists (Administration and Drug Shipment) | 34232 | Sarasota | Florida |
| Florida Cancer Specialists | 32308 | Tallahassee | Florida |
| Florida Cancer Specialists (Administration and Drug Shipment) | 32163 | The Villages | Florida |
| Northwestern Memorial Hospital | 60611 | Chicago | Illinois |
| Ochsner Clinic Foundation | 70121 | Jefferson | Louisiana |
| Henry Ford Hospital | 48202 | Detroit | Michigan |
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