Trial Title:
Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer
NCT ID:
NCT05676931
Condition:
Advanced Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Quemliclustat
Conditions: Keywords:
Advanced Non-Small Cell Lung Cancer
Domvanalimab
Zimberelimab
Quemliclustat
Anti-TIGIT antibody
Anti-PD-1 antibody
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Domvanalimab
Description:
Administered as specified in the treatment arm
Arm group label:
A1: Domvanalimab + Zimberelimab
Arm group label:
A2: Domvanalimab + Zimberelimab
Arm group label:
B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Arm group label:
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Arm group label:
C2: Domvanalimab + Zimberelimab + Docetaxel
Intervention type:
Drug
Intervention name:
Quemliclustat
Description:
Administered as specified in the treatment arm
Arm group label:
A3: Quemliclustat + Zimberelimab
Arm group label:
B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Arm group label:
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Arm group label:
C1: Quemliclustat + Zimberelimab + Docetaxel
Arm group label:
C2: Domvanalimab + Zimberelimab + Docetaxel
Intervention type:
Drug
Intervention name:
Zimberelimab
Description:
Administered as specified in the treatment arm
Arm group label:
A1: Domvanalimab + Zimberelimab
Arm group label:
A2: Domvanalimab + Zimberelimab
Arm group label:
A3: Quemliclustat + Zimberelimab
Arm group label:
B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Arm group label:
B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Arm group label:
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Arm group label:
C1: Quemliclustat + Zimberelimab + Docetaxel
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Administered as specified in the treatment arm
Arm group label:
C1: Quemliclustat + Zimberelimab + Docetaxel
Arm group label:
C2: Domvanalimab + Zimberelimab + Docetaxel
Intervention type:
Drug
Intervention name:
Platinum-Based Doublet
Description:
Administered as specified in the treatment arm
Arm group label:
B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Arm group label:
B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Arm group label:
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
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).
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham (UAB)
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California San Diego (UCSD)
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Cancer Institute at Memorial Regional Hospital
Address:
City:
Hollywood
Zip:
33021
Country:
United States
Status:
Recruiting
Facility:
Name:
Hematology Oncology Associates Of The Treasure Coast
Address:
City:
Port Saint Lucie
Zip:
34952
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialists (Administration and Drug Shipment)
Address:
City:
Sarasota
Zip:
34232
Country:
United States
Status:
Withdrawn
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Tallahassee
Zip:
32308
Country:
United States
Status:
Withdrawn
Facility:
Name:
Florida Cancer Specialists (Administration and Drug Shipment)
Address:
City:
The Villages
Zip:
32163
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwestern Memorial Hospital
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Facility:
Name:
Ochsner Clinic Foundation
Address:
City:
Jefferson
Zip:
70121
Country:
United States
Status:
Recruiting
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
Kettering Health Cancer Center
Address:
City:
Kettering
Zip:
45429
Country:
United States
Status:
Withdrawn
Facility:
Name:
Tennessee Oncology, PLLC
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Withdrawn
Facility:
Name:
Virginia Cancer Specialists, PC
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Medical Oncology Associated, PS (dba Summit Cancer Centers)
Address:
City:
Spokane
Zip:
99208
Country:
United States
Status:
Recruiting
Facility:
Name:
The Border Cancer Hospital
Address:
City:
Albury
Country:
Australia
Status:
Recruiting
Facility:
Name:
Coffs Harbour Health Campus
Address:
City:
Coffs Harbour
Zip:
2450
Country:
Australia
Status:
Recruiting
Facility:
Name:
Pindara Private Hospital
Address:
City:
Benowa
Zip:
4217
Country:
Australia
Status:
Recruiting
Facility:
Name:
Cancer Research SA Pty Ltd
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Sir Charles Gairdner Hospital
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
CHU Bordeaux Centre Francois Magendie Hôpital du Haut Lévèque
Address:
City:
Bordeaux
Zip:
33604
Country:
France
Status:
Recruiting
Facility:
Name:
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Address:
City:
Lyon
Zip:
69495
Country:
France
Status:
Recruiting
Facility:
Name:
Institut De Cancerologie Strasbourg Europe ICANS
Address:
City:
Strasboug
Zip:
67033
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital FOCH
Address:
City:
Suresnes
Country:
France
Status:
Recruiting
Facility:
Name:
LTD High Technology Hospital Medcenter
Address:
City:
Batumi
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Caucasus Medical Center
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Israel Georgian Medical Research Clinic Healthycore
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Facility:
Name:
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Ltd Pineo Medical Ecosystem
Address:
City:
Tbilisi
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST
Address:
City:
Meldola
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
Address:
City:
Pesaro
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei tumori di Milano
Address:
City:
Rome
Country:
Italy
Status:
Recruiting
Facility:
Name:
Samsung Changwon Hospital
Address:
City:
Changwon-Si
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongju
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Chonam National University Hwasun Hospital
Address:
City:
Hwasun-gun
Zip:
58128
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Korea University Guro Hospital
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
138-736
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Medpolonia Sp. Z.o.o.
Address:
City:
Poznan
Country:
Poland
Status:
Recruiting
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
8041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitari Mutua Terrassa
Address:
City:
Barcelona
Zip:
8221
Country:
Spain
Status:
Recruiting
Facility:
Name:
UOMI Cancer Centre
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Canarias
Address:
City:
Las Palmas De Gran Canaria
Zip:
35016
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Lucus Augusti
Address:
City:
Lugo
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Quirónsalud Málaga
Address:
City:
Malaga
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario De La Virgen De Valme
Address:
City:
Sevilla
Zip:
41001
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen Macarena
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Vithas Valencia 9 de Octubre
Address:
City:
Valencia
Zip:
46015
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario y Politécnico la Fe
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hualien Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation
Address:
City:
Hualien
Zip:
970
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
E-DA Healthcare Group E-DA Hospital
Address:
City:
Kaoshiung
Zip:
970
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
Address:
City:
New Taipei
Zip:
23561
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Mackey Memorial Hospital
Address:
City:
Taipei
Zip:
104
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital Yumlin Branch
Address:
City:
Yunlin County
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Barts Health NHS Trust St Bartholomew's Hospital
Address:
City:
London
Zip:
W1G 6AF
Country:
United Kingdom
Status:
Recruiting
Start date:
February 21, 2023
Completion date:
December 2027
Lead sponsor:
Agency:
Gilead Sciences
Agency class:
Industry
Collaborator:
Agency:
Arcus Biosciences, Inc.
Agency class:
Industry
Source:
Gilead Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05676931