Advanced Non-Small Cell Lung Cancer Clinical Trial
— EDGE-LungOfficial title:
A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Arcus Biosciences, Inc. | Gilead Sciences |
United States, Australia, France, Korea, Republic of, Spain, Taiwan, United Kingdom,
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 |
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