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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

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