Testing the Safety of Adding Either Monalizumab (IPH2201) or Oleclumab (MEDI9447) to Durvalumab (MEDI4736) Plus Standard Radiation Therapy for Locally Advanced Non-small Cell Lung Cancer (NSCLC), ARCHON-1 Trial

PHASE1CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

October 28, 2019

Primary Completion Date

October 26, 2021

Study Completion Date

September 4, 2025

Conditions
Locally Advanced Lung Non-Small Cell CarcinomaLocally Recurrent Lung Non-Small Cell CarcinomaStage II Lung Cancer AJCC v8Stage III Lung Cancer AJCC v8Unresectable Lung Non-Small Cell Carcinoma
Interventions
RADIATION

Accelerated Hypofractionated Radiation Therapy

160 Gy given as one 4 Gy fraction per day, 5 days per week for 15 fractions.

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Computed Tomography

Undergo brain CT and chest CT

BIOLOGICAL

Durvalumab

Administered intravenously (IV) as a 1500 mg fixed dose over 60 minutes for 13 cycles (1 cycle = 4 weeks), until disease progression or toxicity or death, whichever comes first.

PROCEDURE

Magnetic Resonance Imaging of the Brain with and without Contrast

Undergo brain MRI

BIOLOGICAL

Monalizumab

Administered IV as a 1500 mg fixed dose over 60 minutes (+/- 10 minutes)

BIOLOGICAL

Oleclumab

Administered IV 3000 mg over 60 minutes (+/- 10 minutes)

RADIATION

Radiation Therapy

60 gy given as one 2 Gy fraction per day, 5 days per week for 30 fractions

Trial Locations (56)

19096

Lankenau Medical Center, Wynnewood

19107

Thomas Jefferson University Hospital, Philadelphia

21014

UM Upper Chesapeake Medical Center, Bel Air

21044

Central Maryland Radiation Oncology in Howard County, Columbia

21061

UM Baltimore Washington Medical Center/Tate Cancer Center, Glen Burnie

21201

University of Maryland/Greenebaum Cancer Center, Baltimore

26506

West Virginia University Healthcare, Morgantown

30303

Grady Health System, Atlanta

30308

Emory University Hospital Midtown, Atlanta

30322

Emory University Hospital/Winship Cancer Institute, Atlanta

30342

Emory Saint Joseph's Hospital, Atlanta

30912

Augusta University Medical Center, Augusta

41017

Saint Elizabeth Healthcare Edgewood, Edgewood

43210

Ohio State University Comprehensive Cancer Center, Columbus

48043

McLaren Cancer Institute-Macomb, Mount Clemens

48060

McLaren-Port Huron, Port Huron

48098

Michigan Healthcare Professionals Troy, Troy

48201

Wayne State University/Karmanos Cancer Institute, Detroit

48334

Michigan Healthcare Professionals Farmington, Farmington Hills

Weisberg Cancer Treatment Center, Farmington Hills

48346

McLaren Cancer Institute-Clarkston, Clarkston

Michigan Healthcare Professionals Clarkston, Clarkston

48446

McLaren Cancer Institute-Lapeer Region, Lapeer

48532

McLaren Cancer Institute-Flint, Flint

Singh and Arora Hematology Oncology PC, Flint

48706

McLaren Cancer Institute-Bay City, Bay City

48910

Karmanos Cancer Institute at McLaren Greater Lansing, Lansing

48912

Mid-Michigan Physicians-Lansing, Lansing

49770

McLaren Cancer Institute-Northern Michigan, Petoskey

59405

Benefis Sletten Cancer Institute, Great Falls

59901

Logan Health Medical Center, Kalispell

63110

Washington University School of Medicine, St Louis

63129

Siteman Cancer Center-South County, St Louis

63136

Siteman Cancer Center at Christian Hospital, St Louis

63141

Siteman Cancer Center at West County Hospital, Creve Coeur

63376

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

64064

University of Kansas Cancer Center - Lee's Summit, Lee's Summit

64116

University of Kansas Cancer Center at North Kansas City Hospital, North Kansas City

64154

University of Kansas Cancer Center - North, Kansas City

66112

University of Kansas Cancer Center-West, Kansas City

66160

University of Kansas Cancer Center, Kansas City

66205

University of Kansas Hospital-Westwood Cancer Center, Westwood

66210

University of Kansas Cancer Center-Overland Park, Overland Park

68114

Nebraska Methodist Hospital, Omaha

73104

University of Oklahoma Health Sciences Center, Oklahoma City

77030

M D Anderson Cancer Center, Houston

77079

MD Anderson West Houston, Houston

77384

MD Anderson in The Woodlands, Conroe

77478

MD Anderson in Sugar Land, Sugar Land

77573

MD Anderson League City, League City

83605

Saint Alphonsus Cancer Care Center-Caldwell, Caldwell

83687

Saint Alphonsus Cancer Care Center-Nampa, Nampa

83706

Saint Alphonsus Cancer Care Center-Boise, Boise

97030

Legacy Mount Hood Medical Center, Gresham

97210

Legacy Good Samaritan Hospital and Medical Center, Portland

98686

Legacy Salmon Creek Hospital, Vancouver

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

NRG Oncology

OTHER

lead

National Cancer Institute (NCI)

NIH