Clinical trial NCT05676931: Study With Various Immunotherapy Treatments in Participants With Lung Cancer
Official title: A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Advanced Non-Small Cell Lung Cancer
Keywords: Advanced Non-Small Cell Lung Cancer
Domvanalimab
Zimberelimab
Quemliclustat
Anti-TIGIT antibody
Anti-PD-1 antibody
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Arcus Biosciences, Inc.
First posted: 2023-01-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
timeFrame: Up to 58 months
measure: The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 58 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From date of first dose until the date of death due to any cause (approximately 58 months)
measure: Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
timeFrame: Up to 58 months
measure: Disease Control Rate (DCR)
timeFrame: Up to 58 months
measure: Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
timeFrame: Up to 58 months
measure: Investigational study treatments peak plasma or serum concentration (Cmax)
timeFrame: Up to 58 months
measure: Investigational study treatments time of peak concentration (Tmax)
timeFrame: Up to 58 months
measure: Investigational study treatments area under the plasma or serum concentration versus time curve (AUC)
timeFrame: Up to 58 months
measure: Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants
timeFrame: Up to 58 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB)
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego (UCSD)
state: California
city: Hollywood
country: United States
facility: Memorial Cancer Institute at Memorial Regional Hospital
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates Of The Treasure Coast
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists (Administration and Drug Shipment)
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists
state: Florida
city: The Villages
country: United States
facility: Florida Cancer Specialists (Administration and Drug Shipment)
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Jefferson
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Kettering
country: United States
facility: Kettering Health Cancer Center
state: Ohio
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Spokane
country: United States
facility: Medical Oncology Associated, PS (dba Summit Cancer Centers)
state: Washington
city: Albury
country: Australia
facility: The Border Cancer Hospital
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus
state: New South Wales
city: Benowa
country: Australia
facility: Pindara Private Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Cancer Research SA Pty Ltd
state: South Australia
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Bordeaux
country: France
facility: CHU Bordeaux Centre Francois Magendie Hôpital du Haut Lévèque
city: Lyon
country: France
facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud
city: Strasboug
country: France
facility: Institut De Cancerologie Strasbourg Europe ICANS
city: Suresnes
country: France
facility: Hopital FOCH
city: Batumi
country: Georgia
facility: LTD High Technology Hospital Medcenter
city: Tbilisi
country: Georgia
facility: Caucasus Medical Center
city: Tbilisi
country: Georgia
facility: Israel Georgian Medical Research Clinic Healthycore
city: Tbilisi
country: Georgia
facility: JSC K. Eristavi National Center of Experimental and Clinical Surgery
city: Tbilisi
country: Georgia
facility: Ltd Pineo Medical Ecosystem
city: Meldola
country: Italy
facility: Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST
city: Milan
country: Italy
facility: stituto Nazionale per lo Studio e la Cura dei Tumori
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
city: Pesaro
country: Italy
facility: Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
city: Rome
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei tumori di Milano
city: Changwon-Si
country: Korea, Republic of
facility: Samsung Changwon Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Hwasun-gun
country: Korea, Republic of
facility: Chonam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Gdynia
country: Poland
facility: Szpitale Pomorskie sp. z o.o
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, im. prof. K. Gibińskiego
city: Poznan
country: Poland
facility: Medpolonia Sp. Z.o.o.
city: Warsaw
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Sk?odowskiej-Curie
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Mutua Terrassa
city: Barcelona
country: Spain
facility: UOMI Cancer Centre
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno Infantil De Gran Canaria
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Malaga
country: Spain
facility: Hospital Quirónsalud Málaga
city: Sevilla
country: Spain
facility: Hospital Universitario De La Virgen De Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital 9 de Octubre Vithas Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico la Fe
city: Hualien
country: Taiwan
facility: Hualien Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation
city: Kaoshiung
country: Taiwan
facility: E-DA Healthcare Group E-DA Hospital
city: New Taipei
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
city: Taipei
country: Taiwan
facility: Mackey Memorial Hospital
city: Yunlin County
country: Taiwan
facility: National Taiwan University Hospital Yumlin Branch
city: London
country: United Kingdom
facility: Barts Health NHS Trust St Bartholomew's Hospital
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: