Study With Various Immunotherapy Treatments in Participants With Lung Cancer
Phase 2
Recruiting
- Conditions
- Advanced Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05676931
- Lead Sponsor
- Gilead Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description A1: Domvanalimab + Zimberelimab Domvanalimab Domvanalimab and Zimberelimab, both administered by IV infusion A1: Domvanalimab + Zimberelimab Zimberelimab Domvanalimab and Zimberelimab, both administered by IV infusion A2: Domvanalimab + Zimberelimab Domvanalimab Domvanalimab and Zimberelimab, both administered by IV infusion A2: Domvanalimab + Zimberelimab Zimberelimab Domvanalimab and Zimberelimab, both administered by IV infusion A3: Quemliclustat + Zimberelimab Quemliclustat Quemliclustat and Zimberelimab, both administered by IV infusion A3: Quemliclustat + Zimberelimab Zimberelimab Quemliclustat and Zimberelimab, both administered by IV infusion B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy Quemliclustat Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy Zimberelimab Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy Platinum-Based Doublet Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy Domvanalimab Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy Zimberelimab Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy Platinum-Based Doublet Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy Domvanalimab Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy Quemliclustat Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy Zimberelimab Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy Platinum-Based Doublet Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B4: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy Domvanalimab Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B4: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy Zimberelimab Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B4: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy Platinum-Based Doublet Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B5: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy Domvanalimab Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B5: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy Zimberelimab Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion B5: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy Platinum-Based Doublet Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion C1: Quemliclustat + Zimberelimab + Docetaxel Quemliclustat Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion C1: Quemliclustat + Zimberelimab + Docetaxel Zimberelimab Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion C1: Quemliclustat + Zimberelimab + Docetaxel Docetaxel Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion C2: Domvanalimab + Zimberelimab + Docetaxel Domvanalimab Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion C2: Domvanalimab + Zimberelimab + Docetaxel Zimberelimab Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion C2: Domvanalimab + Zimberelimab + Docetaxel Docetaxel Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Up to 58 months The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Up to 58 months
- Secondary Outcome Measures
Name Time Method Investigational study treatments time of peak concentration (Tmax) Up to 58 months Overall Survival (OS) From date of first dose until the date of death due to any cause (approximately 58 months) Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1 Up to 58 months Disease Control Rate (DCR) Up to 58 months Duration of response (DoR) as determined by the Investigator according to RECIST v1.1 Up to 58 months Investigational study treatments peak plasma or serum concentration (Cmax) Up to 58 months Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants Up to 58 months Investigational study treatments area under the plasma or serum concentration versus time curve (AUC) Up to 58 months
Trial Locations
- Locations (57)
University of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
University of California San Diego (UCSD)
🇺🇸La Jolla, California, United States
Memorial Cancer Institute at Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Hematology Oncology Associates Of The Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
Florida Cancer Specialists (Administration and Drug Shipment)
🇺🇸The Villages, Florida, United States
Florida Cancer Specialists
🇺🇸Tallahassee, Florida, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Ochsner Clinic Foundation
🇺🇸Jefferson, Louisiana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Kettering Health Cancer Center
🇺🇸Kettering, Ohio, United States
Scroll for more (47 remaining)University of Alabama at Birmingham (UAB)🇺🇸Birmingham, Alabama, United States