Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer

Advanced Non-Small Cell Lung Cancer Clinical Trial

— EDGE-Lung  

Official title:

A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05676931
• Other study ID #: EDGE-Lung
• Secondary ID: 2022-502916-35-0
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2023
• Est. completion date: September 2026

Study information

• Verified date: June 2024
• Source: Arcus Biosciences, Inc.
• Contact: Arcus Biosciences
• Phone: 1-888-44-ARCUS
• Email: ClinicalTrials[@]arcusbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Non-Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• Domvanalimab
Administered as specified in the treatment arm
• Quemliclustat
Administered as specified in the treatment arm
• Zimberelimab
Administered as specified in the treatment arm
• Docetaxel
Administered as specified in the treatment arm
• Platinum-Based Doublet
Administered as specified in the treatment arm

Locations

Country	Name	City	State
Australia	Cancer Research SA	Adelaide
Australia	Border Cancer Hospital	Albury
Australia	Pindara Private Hospital	Benowa
Australia	Coffs Harbour Health Campus	Coffs Harbour
France	Hospital FOCH	Suresnes
Korea, Republic of	Samsung Changwon Hospital	Changwon
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	Chonnam National University Hwasun Hospital	Kwangju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Spain	Hospital Universitario MútuaTerrassa (HUMT)	Barcelona
Spain	Hospital Virgen Macarena / HUVM	Sevilla
Taiwan	Hualien Tzu Chi Hospital	Hualien City
Taiwan	E-Da Hospital	Kaohsiung
Taiwan	Taipai Medical University - Shuang Ho Hospital	New Taipei City
Taiwan	Mackay Memorial Hospital Taipei	Taipei
United Kingdom	St. Bartholomew's Hospital	London
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northwestern University	Chicago	Illinois
United States	Henry Ford Hospital	Detroit	Michigan
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Memorial Healthcare Institute	Hollywood	Florida
United States	Ochsner Clinic Foundation	Jefferson	Louisiana
United States	Kettering Medical Center	Kettering	Ohio
United States	Tennessee Oncology	Nashville	Tennessee
United States	Hematology Oncology Associates of the Treasure Coast	Port Saint Lucie	Florida
United States	SCRI - Florida Cancer Specialists South	Sarasota	Florida
United States	Medical Oncology Associates	Spokane	Washington
United States	SCRI - Florida Cancer Specialists Panhandle	Tallahassee	Florida
United States	SCRI - Florida Cancer Specialists North	The Villages	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Arcus Biosciences, Inc.	Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  France,  Korea, Republic of,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)		Up to 58 months
Primary	The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)		Up to 58 months
Secondary	Overall Survival (OS)		From date of first dose until the date of death due to any cause (approximately 58 months)
Secondary	Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1		Up to 58 months
Secondary	Disease Control Rate (DCR)		Up to 58 months
Secondary	Duration of response (DoR) as determined by the Investigator according to RECIST v1.1		Up to 58 months
Secondary	Investigational study treatments peak plasma or serum concentration (Cmax)		Up to 58 months
Secondary	Investigational study treatments time of peak concentration (Tmax)		Up to 58 months
Secondary	Investigational study treatments area under the plasma or serum concentration versus time curve (AUC)		Up to 58 months
Secondary	Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants		Up to 58 months