Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

May 2, 2023 updated by: SWOG Cancer Research Network

A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)

This phase II/III Lung-MAP trial studies how well immunotherapy treatment with N-803 (ALT-803) and pembrolizumab working in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. N-803 (ALT-803) may activate natural killer cells so that they can stimulate an immune response to help fight cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving N-803 (ALT-803) and pembrolizumab may help shrink and stabilize lung cancer or prevent it from returning.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare overall survival (OS) between participants randomized to nogapendekin alfa (N-803 [ALT-803]) + pembrolizumab versus standard of care therapy. (Primary Resistance Cohort) II. To compare overall survival (OS) between participants randomized to N-803 (ALT-803) + pembrolizumab versus standard of care therapy. (Acquired Resistance Cohort)

SECONDARY OBJECTIVES:

I. To compare investigator assessed progression-free survival (IA-PFS) with confirmation of progression by immune response criteria between the treatment arms.

II. To compare investigator assessed progression-free survival (IA-PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the treatment arms.

III. To compare the response rates between the arms. IV. To evaluate duration of response (DoR) among responders. V. To evaluate the frequency and severity of toxicities within each treatment arm.

TRANSLATIONAL MEDICINE OBJECTIVE:

I. To establish a blood repository to pursue future studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive standard of care consisting of docetaxel intravenously (IV) over 30-60 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; pemetrexed IV over 10 minutes on day 1; or ramucirumab IV over 30-60 minutes and docetaxel IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive pembrolizumab IV over 30 minutes and nogapendekin alfa subcutaneously (SC) on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients then receive nogapendekin alfa SC on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Veterans Administration Medical Center - Birmingham
- Arizona
  - Goodyear, Arizona, United States, 85338
    - CTCA at Western Regional Medical Center
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas For Medical Sciences
- California
  - Anaheim, California, United States, 92806
    - Kaiser Permanente-Anaheim
  - Arroyo Grande, California, United States, 93420
    - PCR Oncology
  - Auburn, California, United States, 95602
    - Sutter Auburn Faith Hospital
  - Baldwin Park, California, United States, 91706
    - Kaiser Permanente-Baldwin Park
  - Bellflower, California, United States, 90706
    - Kaiser Permanente-Bellflower
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Beverly Hills, California, United States, 90211
    - Tower Cancer Research Foundation
  - Fontana, California, United States, 92335
    - Kaiser Permanente-Fontana
  - Fremont, California, United States, 94538
    - Palo Alto Medical Foundation-Fremont
  - Harbor City, California, United States, 90710
    - Kaiser Permanente - Harbor City
  - Irvine, California, United States, 92618
    - Kaiser Permanente-Irvine
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Los Angeles, California, United States, 90048
    - Cedars Sinai Medical Center
  - Los Angeles, California, United States, 90034
    - Kaiser Permanente West Los Angeles
  - Modesto, California, United States, 95355
    - Memorial Medical Center
  - Oakland, California, United States, 94611
    - Kaiser Permanente-Oakland
  - Ontario, California, United States, 91761
    - Kaiser Permanente-Ontario
  - Palo Alto, California, United States, 94301
    - Palo Alto Medical Foundation Health Care
  - Panorama City, California, United States, 91402
    - Kaiser Permanente - Panorama City
  - Rancho Mirage, California, United States, 92270
    - Eisenhower Medical Center
  - Riverside, California, United States, 92505
    - Kaiser Permanente-Riverside
  - Roseville, California, United States, 95661
    - Kaiser Permanente-Roseville
  - Roseville, California, United States, 95661
    - Sutter Roseville Medical Center
  - Sacramento, California, United States, 95816
    - Sutter Medical Center Sacramento
  - Sacramento, California, United States, 95817
    - University of California Davis Comprehensive Cancer Center
  - Sacramento, California, United States, 95814
    - Kaiser Permanente Downtown Commons
  - San Diego, California, United States, 92120
    - Kaiser Permanente-San Diego Zion
  - San Francisco, California, United States, 94121
    - Veterans Affairs Medical Center - San Francisco
  - San Francisco, California, United States, 94115
    - Kaiser Permanente-San Francisco
  - San Francisco, California, United States, 94115
    - California Pacific Medical Center-Pacific Campus
  - San Jose, California, United States, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Leandro, California, United States, 94577
    - Kaiser Permanente San Leandro
  - San Marcos, California, United States, 92078
    - Kaiser Permanente-San Marcos
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Cruz, California, United States, 95065
    - Palo Alto Medical Foundation-Santa Cruz
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente-South San Francisco
  - Sunnyvale, California, United States, 94086
    - Palo Alto Medical Foundation-Sunnyvale
  - Torrance, California, United States, 90505
    - Torrance Memorial Physician Network - Cancer Care
  - Vallejo, California, United States, 94589
    - Kaiser Permanente-Vallejo
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center/Cancer Center
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente-Walnut Creek
  - Whittier, California, United States, 90602
    - Presbyterian Intercommunity Hospital
  - Woodland Hills, California, United States, 91367
    - Kaiser Permanente-Woodland Hills
- Connecticut
  - West Haven, Connecticut, United States, 06516
    - Veterans Affairs Connecticut Healthcare System-West Haven Campus
- Delaware
  - Dover, Delaware, United States, 19901
    - Bayhealth Hospital Kent Campus
  - Frankford, Delaware, United States, 19945
    - Beebe South Coastal Health Campus
  - Milford, Delaware, United States, 19963
    - Bayhealth Hospital Sussex Campus
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
- District of Columbia
  - Washington, District of Columbia, United States, 20002
    - Kaiser Permanente-Capitol Hill Medical Center
- Florida
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Medical Center
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Northside Hospital
  - Duluth, Georgia, United States, 30096
    - Northside Hospital - Duluth
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center-Gainesville
  - Lawrenceville, Georgia, United States, 30046
    - Northside Hospital - Gwinnett
  - Savannah, Georgia, United States, 31405
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, United States, 83712
    - Saint Luke's Cancer Institute - Boise
  - Fruitland, Idaho, United States, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, United States, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, United States, 83686
    - Saint Luke's Cancer Institute - Nampa
  - Twin Falls, Idaho, United States, 83301
    - Saint Luke's Cancer Institute - Twin Falls
- Illinois
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Danville, Illinois, United States, 61832
    - Carle on Vermilion
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Dixon, Illinois, United States, 61021
    - Illinois CancerCare-Dixon
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg
  - Hines, Illinois, United States, 60141
    - Edward Hines Jr VA Hospital
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Lake Forest, Illinois, United States, 60045
    - Northwestern Medicine Lake Forest Hospital
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - O'Fallon, Illinois, United States, 62269
    - Cancer Care Center of O'Fallon
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Rockford, Illinois, United States, 61103
    - Mercyhealth Javon Bea Hospital - Rockton
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Springfield, Illinois, United States, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, United States, 62702
    - Springfield Clinic
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Urbana, Illinois, United States, 61801
    - The Carle Foundation Hospital
  - Washington, Illinois, United States, 61571
    - Illinois CancerCare - Washington
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University/Melvin and Bren Simon Cancer Center
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC - Ames
  - Ames, Iowa, United States, 50010
    - Mary Greeley Medical Center
  - Bettendorf, Iowa, United States, 52722
    - University of Iowa Healthcare Cancer Services Quad Cities
  - Boone, Iowa, United States, 50036
    - McFarland Clinic PC-Boone
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Creston, Iowa, United States, 50801
    - Greater Regional Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mission Cancer and Blood - Laurel
  - Fort Dodge, Iowa, United States, 50501
    - McFarland Clinic PC-Trinity Cancer Center
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic PC-Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic PC-Marshalltown
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Hays, Kansas, United States, 67601
    - HaysMed University of Kansas Health System
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Olathe, Kansas, United States, 66061
    - Olathe Health Cancer Center
  - Overland Park, Kansas, United States, 66210
    - University of Kansas Cancer Center-Overland Park
  - Overland Park, Kansas, United States, 66211
    - University of Kansas Hospital-Indian Creek Campus
  - Salina, Kansas, United States, 67401
    - Salina Regional Health Center
  - Topeka, Kansas, United States, 66606
    - University of Kansas Health System Saint Francis Campus
  - Westwood, Kansas, United States, 66205
    - University of Kansas Hospital-Westwood Cancer Center
  - Wichita, Kansas, United States, 67214
    - Ascension Via Christi Hospitals Wichita
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Wichita
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky/Markey Cancer Center
  - Owensboro, Kentucky, United States, 42303
    - Owensboro Health Mitchell Memorial Cancer Center
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Louisiana Hematology Oncology Associates LLC
- Maine
  - Augusta, Maine, United States, 04330
    - Harold Alfond Center for Cancer Care
  - Biddeford, Maine, United States, 04005
    - MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
  - Brewer, Maine, United States, 04412
    - Lafayette Family Cancer Center-EMMC
  - Sanford, Maine, United States, 04073
    - MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
- Maryland
  - Baltimore, Maryland, United States, 21244
    - Kaiser Permanente-Woodlawn Medical Center
  - Cumberland, Maryland, United States, 21502
    - UPMC Western Maryland
  - Gaithersburg, Maryland, United States, 20879
    - Kaiser Permanente-Gaithersburg Medical Center
  - Kensington, Maryland, United States, 20895
    - Kaiser Permanente - Kensington Medical Center
  - Largo, Maryland, United States, 20774
    - Kaiser Permanente - Largo Medical Center
  - Westminster, Maryland, United States, 21157
    - William E Kahlert Regional Cancer Center/Sinai Hospital
- Massachusetts
  - Beverly, Massachusetts, United States, 01915
    - Beverly Hospital
  - Burlington, Massachusetts, United States, 01805
    - Lahey Hospital and Medical Center
  - Gloucester, Massachusetts, United States, 01930
    - Addison Gilbert Hospital
  - Peabody, Massachusetts, United States, 01960
    - Lahey Medical Center-Peabody
  - Worcester, Massachusetts, United States, 01655
    - UMass Memorial Medical Center - University Campus
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - Saint Joseph Mercy Hospital
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Brighton, Michigan, United States, 48114
    - Saint Joseph Mercy Brighton
  - Brighton, Michigan, United States, 48114
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Canton, Michigan, United States, 48188
    - Saint Joseph Mercy Canton
  - Canton, Michigan, United States, 48188
    - Trinity Health IHA Medical Group Hematology Oncology - Canton
  - Chelsea, Michigan, United States, 48118
    - Saint Joseph Mercy Chelsea
  - Chelsea, Michigan, United States, 48118
    - Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  - Detroit, Michigan, United States, 48236
    - Ascension Saint John Hospital
  - East China Township, Michigan, United States, 48054
    - Great Lakes Cancer Management Specialists-Doctors Park
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesee Cancer and Blood Disease Treatment Center
  - Flint, Michigan, United States, 48503
    - Genesee Hematology Oncology PC
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Academic Hematology Oncology Specialists
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49009
    - Ascension Borgess Cancer Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Macomb, Michigan, United States, 48044
    - Great Lakes Cancer Management Specialists-Macomb Medical Campus
  - Novi, Michigan, United States, 48374
    - Ascension Providence Hospitals - Novi
  - Saginaw, Michigan, United States, 48601
    - Ascension Saint Mary's Hospital
  - Saginaw, Michigan, United States, 48604
    - Oncology Hematology Associates of Saginaw Valley PC
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Southfield, Michigan, United States, 48075
    - Ascension Providence Hospitals - Southfield
  - Sterling Heights, Michigan, United States, 48312
    - Bhadresh Nayak MD PC-Sterling Heights
  - Tawas City, Michigan, United States, 48764
    - Ascension Saint Joseph Hospital
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
  - Warren, Michigan, United States, 48093
    - Great Lakes Cancer Management Specialists-Macomb Professional Building
  - Ypsilanti, Michigan, United States, 48197
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
  - Ypsilanti, Michigan, United States, 48106
    - Huron Gastroenterology PC
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Sanford Joe Lueken Cancer Center
  - Deer River, Minnesota, United States, 56636
    - Essentia Health - Deer River Clinic
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hibbing, Minnesota, United States, 55746
    - Essentia Health Hibbing Clinic
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55417
    - Minneapolis VA Medical Center
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Sandstone, Minnesota, United States, 55072
    - Essentia Health Sandstone
  - Virginia, Minnesota, United States, 55792
    - Essentia Health Virginia Clinic
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - University of Mississippi Medical Center
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Creve Coeur, Missouri, United States, 63141
    - Siteman Cancer Center at West County Hospital
  - Farmington, Missouri, United States, 63640
    - Parkland Health Center - Farmington
  - Kansas City, Missouri, United States, 64154
    - University of Kansas Cancer Center - North
  - Kansas City, Missouri, United States, 64108
    - Truman Medical Centers
  - Lee's Summit, Missouri, United States, 64064
    - University of Kansas Cancer Center - Lee's Summit
  - North Kansas City, Missouri, United States, 64116
    - University of Kansas Cancer Center at North Kansas City Hospital
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63129
    - Siteman Cancer Center-South County
  - Saint Louis, Missouri, United States, 63136
    - Siteman Cancer Center at Christian Hospital
  - Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center at Saint Peters Hospital
  - Sainte Genevieve, Missouri, United States, 63670
    - Sainte Genevieve County Memorial Hospital
  - Sullivan, Missouri, United States, 63080
    - Missouri Baptist Sullivan Hospital
  - Sunset Hills, Missouri, United States, 63127
    - Missouri Baptist Outpatient Center-Sunset Hills
- Montana
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - OptumCare Cancer Care at Charleston
  - Las Vegas, Nevada, United States, 89148
    - OptumCare Cancer Care at Fort Apache
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
- New Hampshire
  - Concord, New Hampshire, United States, 03301
    - New Hampshire Oncology Hematology PA-Concord
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center
  - Manchester, New Hampshire, United States, 03103
    - Solinsky Center for Cancer Care
- New Jersey
  - Moorestown, New Jersey, United States, 08057
    - Virtua Samson Cancer Center
  - Voorhees, New Jersey, United States, 08043
    - Virtua Voorhees
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, United States, 87110
    - Presbyterian Kaseman Hospital
  - Las Cruces, New Mexico, United States, 88011
    - Memorial Medical Center - Las Cruces
  - Rio Rancho, New Mexico, United States, 87124
    - Presbyterian Rust Medical Center/Jorgensen Cancer Center
- New York
  - Cooperstown, New York, United States, 13326
    - Mary Imogene Bassett Hospital
  - East Hills, New York, United States, 11548
    - Cancer Institute at Saint Francis Hospital
  - Elmira, New York, United States, 14905
    - Arnot Ogden Medical Center/Falck Cancer Center
  - Rochester, New York, United States, 14642
    - University of Rochester
  - West Islip, New York, United States, 11795
    - Good Samaritan Hospital Medical Center
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - Randolph Hospital
  - Asheville, North Carolina, United States, 28803
    - AdventHealth Infusion Center Asheville
  - Burlington, North Carolina, United States, 27215
    - Cone Health Cancer Center at Alamance Regional
  - Clyde, North Carolina, United States, 28721
    - AdventHealth Infusion Center Haywood
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Durham, North Carolina, United States, 27705
    - Durham VA Medical Center
  - Greensboro, North Carolina, United States, 27403
    - Cone Health Cancer Center
  - Hendersonville, North Carolina, United States, 28792
    - AdventHealth Hendersonville
  - Mebane, North Carolina, United States, 27302
    - Cone Heath Cancer Center at Mebane
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth of the Carolinas-Moore Regional Hospital
  - Raleigh, North Carolina, United States, 27609
    - Duke Raleigh Hospital
  - Raleigh, North Carolina, United States, 27607
    - Duke Women's Cancer Care Raleigh
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Memorial Hospital
  - Weaverville, North Carolina, United States, 28787
    - AdventHealth Infusion Center Weaverville
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Broadway Medical Center
- Ohio
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Canton, Ohio, United States, 44708
    - Cleveland Clinic Mercy Hospital
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Mansfield, Ohio, United States, 44906
    - Cleveland Clinic Cancer Center Mansfield
  - Marion, Ohio, United States, 43302
    - OhioHealth Marion General Hospital
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Hospital Cancer Center
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Springfield, Ohio, United States, 45504
    - Springfield Regional Cancer Center
  - Steubenville, Ohio, United States, 43952
    - Trinity's Tony Teramana Cancer Center
  - Strongsville, Ohio, United States, 44136
    - Cleveland Clinic Cancer Center Strongsville
  - Sylvania, Ohio, United States, 43560
    - ProMedica Flower Hospital
  - Warrensville Heights, Ohio, United States, 44122
    - South Pointe Hospital
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Wooster, Ohio, United States, 44691
    - Cleveland Clinic Wooster Family Health and Surgery Center
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Lawton, Oklahoma, United States, 73505
    - Cancer Centers of Southwest Oklahoma Research
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Hospital Oklahoma City
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health and Science University
  - Portland, Oregon, United States, 97227
    - Kaiser Permanente Northwest
- Pennsylvania
  - Altoona, Pennsylvania, United States, 16601
    - UPMC Altoona
  - Beaver, Pennsylvania, United States, 15009
    - UPMC-Heritage Valley Health System Beaver
  - Butler, Pennsylvania, United States, 16001
    - UPMC Hillman Cancer Center at Butler Health System
  - Camp Hill, Pennsylvania, United States, 17011
    - UPMC Camp Hill
  - Carlisle, Pennsylvania, United States, 17015
    - Carlisle Regional Cancer Center
  - Chambersburg, Pennsylvania, United States, 17201
    - WellSpan Medical Oncology and Hematology
  - Cranberry Township, Pennsylvania, United States, 16066
    - UPMC Hillman Cancer Center - Passavant - Cranberry
  - Ephrata, Pennsylvania, United States, 17522
    - Ephrata Cancer Center
  - Erie, Pennsylvania, United States, 16505
    - UPMC Hillman Cancer Center Erie
  - Farrell, Pennsylvania, United States, 16121
    - UPMC Cancer Center at UPMC Horizon
  - Gettysburg, Pennsylvania, United States, 17325
    - Adams Cancer Center
  - Greensburg, Pennsylvania, United States, 15601
    - UPMC Cancer Centers - Arnold Palmer Pavilion
  - Greenville, Pennsylvania, United States, 16125
    - Oncology Hematology Associates
  - Harrisburg, Pennsylvania, United States, 17109
    - UPMC Pinnacle Cancer Center/Community Osteopathic Campus
  - Indiana, Pennsylvania, United States, 15701
    - IRMC Cancer Center
  - Johnstown, Pennsylvania, United States, 15901
    - UPMC-Johnstown/John P. Murtha Regional Cancer Center
  - Lebanon, Pennsylvania, United States, 17042
    - Sechler Family Cancer Center
  - McKeesport, Pennsylvania, United States, 15132
    - UPMC Cancer Center at UPMC McKeesport
  - Mechanicsburg, Pennsylvania, United States, 17050
    - UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
  - Monroeville, Pennsylvania, United States, 15146
    - UPMC Hillman Cancer Center - Monroeville
  - Moon, Pennsylvania, United States, 15108
    - UPMC-Coraopolis/Heritage Valley Radiation Oncology
  - Mount Pleasant, Pennsylvania, United States, 15666
    - UPMC Hillman Cancer Center - Part of Frick Hospital
  - N. Huntingdon, Pennsylvania, United States, 15642
    - Arnold Palmer Cancer Center Medical Oncology Norwin
  - Natrona Heights, Pennsylvania, United States, 15065
    - UPMC Cancer Center-Natrona Heights
  - New Castle, Pennsylvania, United States, 16105
    - UPMC Hillman Cancer Center - New Castle
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, United States, 19140
    - Temple University Hospital
  - Pittsburgh, Pennsylvania, United States, 15232
    - University of Pittsburgh Cancer Institute (UPCI)
  - Pittsburgh, Pennsylvania, United States, 15237
    - UPMC-Passavant Hospital
  - Pittsburgh, Pennsylvania, United States, 15243
    - UPMC-Saint Clair Hospital Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15219
    - UPMC-Mercy Hospital
  - Pottstown, Pennsylvania, United States, 19464
    - Pottstown Hospital
  - Seneca, Pennsylvania, United States, 16346
    - UPMC Cancer Center at UPMC Northwest
  - Uniontown, Pennsylvania, United States, 15401
    - UPMC Cancer Center-Uniontown
  - Washington, Pennsylvania, United States, 15301
    - UPMC Cancer Center-Washington
  - West Mifflin, Pennsylvania, United States, 15122
    - UPMC West Mifflin-Cancer Center Jefferson
  - Williamsport, Pennsylvania, United States, 17754
    - Divine Providence Hospital
  - York, Pennsylvania, United States, 17403
    - WellSpan Health-York Cancer Center
  - York, Pennsylvania, United States, 17403
    - WellSpan Health-York Hospital
  - York, Pennsylvania, United States, 17403
    - Cancer Care Associates of York
  - York, Pennsylvania, United States, 17408
    - UPMC Memorial
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Cancer Center
  - Boiling Springs, South Carolina, United States, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Charleston, South Carolina, United States, 29401
    - Ralph H Johnson VA Medical Center
  - Easley, South Carolina, United States, 29640
    - Prisma Health Cancer Institute - Easley
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Greenville Memorial Hospital
  - Greer, South Carolina, United States, 29650
    - Prisma Health Cancer Institute - Greer
  - Seneca, South Carolina, United States, 29672
    - Prisma Health Cancer Institute - Seneca
- South Dakota
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic
- Texas
  - Amarillo, Texas, United States, 79106
    - The Don and Sybil Harrington Cancer Center
  - Dallas, Texas, United States, 75235
    - Parkland Memorial Hospital
  - Dallas, Texas, United States, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Fort Worth, Texas, United States, 76104
    - UT Southwestern/Simmons Cancer Center-Fort Worth
  - Richardson, Texas, United States, 75080
    - UT Southwestern Clinical Center at Richardson/Plano
- Virginia
  - Burke, Virginia, United States, 22015
    - Kaiser Permanente-Burke Medical Center
  - McLean, Virginia, United States, 22102
    - Kaiser Permanente Tysons Corner Medical Center
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - West Virginia University Charleston Division
  - Huntington, West Virginia, United States, 25701
    - Edwards Comprehensive Cancer Center
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Healthcare
- Wisconsin
  - Ashland, Wisconsin, United States, 54806
    - Duluth Clinic Ashland
  - Grafton, Wisconsin, United States, 53024
    - Aurora Cancer Care-Grafton
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, United States, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Janesville, Wisconsin, United States, 53548
    - Mercyhealth Hospital and Cancer Center - Janesville
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Carbone Cancer Center
  - Menomonee Falls, Wisconsin, United States, 53051
    - Froedtert Menomonee Falls Hospital
  - Milwaukee, Wisconsin, United States, 53226
    - Medical College of Wisconsin
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Milwaukee, Wisconsin, United States, 53233
    - Aurora Sinai Medical Center
  - Oconto Falls, Wisconsin, United States, 54154
    - Saint Vincent Hospital Cancer Center at Oconto Falls
  - Sturgeon Bay, Wisconsin, United States, 54235-1495
    - Saint Vincent Hospital Cancer Center at Sturgeon Bay
  - Summit, Wisconsin, United States, 53066
    - Aurora Medical Center in Summit
  - Wauwatosa, Wisconsin, United States, 53226
    - Aurora Cancer Care-Milwaukee West
  - West Allis, Wisconsin, United States, 53227
    - Aurora West Allis Medical Center
  - West Bend, Wisconsin, United States, 53095
    - Froedtert West Bend Hospital/Kraemer Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Participants must have been assigned to S1800D by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800D is determined by the LUNGMAP or S1400 protocol
Participants must have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). Measurable disease must be assessed within 28 days prior to randomization. Non-measurable disease must be assessed within 42 days prior to randomization. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization
Participants with spinal cord compression or brain metastases must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization
Participants with spinal cord compression or brain metastases must not have residual neurological dysfunction, unless no further recovery is expected, and the participant has been stable on weaning doses of corticosteroids (=< 10 mg daily prednisone or equivalent) prior to sub-study randomization
Participants must have progressed (in the opinion of the treating investigator) following the most recent line of therapy for non-small cell lung cancer (NSCLC)
Participants with a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists (e.g. EGFR, ALK gene fusions, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s)
Participants must have received exactly one line of anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent, or stage III in certain circumstances outlined below) given alone or in combination with platinum-based chemotherapy. Participants must have experienced disease progression during or after this regimen
- Continuing the same agent(s) after progression counts as a single line of therapy. However, a change or addition in agent(s) after progression (e.g. the addition of chemotherapy to anti-PD-1 monotherapy after progression) counts as a subsequent line of therapy and would exclude the participant
- For participants who received consolidation anti-PD-1 or anti-PD-L1 therapy following concurrent chemoradiation for Stage III disease as their only line of anti-PD-1 or anti-PD-L1 therapy:
  - If they experienced disease progression less than (<) 365 days from the first date of anti-PD-1 or anti-PD-L1 therapy, this counts as the single line of anti-PD-1 or anti-PD-L1 therapy for advanced disease
  - If they experienced disease progression more than or equal to (>=) 365 days from the first date of anti-PD-1 or anti-PD-L1 therapy, this is not considered a line of anti-PD-1 or anti-PD-L1 therapy for advanced disease
Participants must have recovered (=< grade 1) from any side effects of prior therapy, except for alopecia
Participants must be able to safely receive at least one of the investigator's choice of standard of care regimens, per the current FDA-approved package insert
- Note: Pemetrexed is not FDA-approved for squamous cell NSCLC and must not be used to treat participants with squamous cell NSCLC
Absolute neutrophil count (ANC) >= 1.5 x 10^3/uL (obtained within 28 days prior to sub-study randomization)
Platelet count >= 100 x 10^3/uL(obtained within 28 days prior to sub-study randomization)
Hemoglobin >= 9 g/dL (obtained within 28 days prior to sub-study randomization)
Serum bilirubin =< institutional upper limit of normal (IULN) (within 28 days prior to sub-study randomization). For participants with liver metastases, bilirubin must be =< 5 x IULN
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2 x IULN (within 28 days prior to sub-study randomization). For participants with liver metastases, ALT and AST must be =< 5 x IULN
Serum creatinine =< the IULN or calculated creatinine clearance >= 50 mL/min using Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization
Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization
Participants must have history and physical exam must be obtained within 28 days prior to sub-study randomization
Participants with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to sub-study randomization
Participants must also be offered participation in banking and in the correlative studies for collection and future use of specimens
Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria:

Participants must not have leptomeningeal disease that requires CNS-specific treatment prior to registration and must not be planning to receive the CNS-specific treatment through the first cycle of the protocol therapy
Participants must not have experienced the following:
- Any grade 3 or worse immune-related adverse event (irAE). Exception: asymptomatic nonbullous/nonexfoliative rash
- Any unresolved grade 2 irAE
- Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy
- Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed
Participants must not have any history of organ transplant that requires use of immunosuppressives
Participants must not have history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease
Participants must not have any known allergy or reaction to any component of the investigational formulations. If there is a known allergy or reaction to standard of care formulations, participants must be able to safely receive at least one of the standard of care options
Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months prior to sub-study randomization, or serious uncontrolled cardiac arrhythmia
Participants must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to sub-study randomization
Participants must not have an active or uncontrolled infection in the opinion of the treating investigator
Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
Participants must not have any of following:
- Cirrhosis at a level of Child-Pugh B (or worse)
- Cirrhosis (any degree) and a history of hepatic encephalopathy
- Or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
Participants must not have received anti-CTLA4 therapy (e.g. ipilimumab, tremelimumab), or other immune-modulatory therapy (e.g. anti-TIM-3, anti-LAG-3, anti-GITR, IL-2, IL-15)
Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization
Participants must not have received any radiation therapy within 14 days prior to sub-study randomization
Participants must not have received nitrosoureas or mitomycin-c within 42 days prior to sub-study randomization
Participants must not have received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 7 days prior to sub-study randomization. Inhaled or topical steroids, and adrenal replacement doses =< 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease
Participants must not have received a live attenuated vaccination within 28 days prior to sub-study randomization. All COVID-19 vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency use authorization are acceptable
Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participant must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
Participants must not have an active autoimmune disease that has required systemic treatment within two years prior to sub-study randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
Participants must not have any history of primary immunodeficiency
Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study and 4 months after completion of study treatment. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures during the study and 4 months after study completion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A (standard of care) Patients receive standard of care consisting of docetaxel IV over 30-60 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; pemetrexed IV over 10 minutes on day 1; or ramucirumab IV over 30-60 minutes and docetaxel IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Drug: Gemcitabine Given IV Other Names: dFdCyd dFdC Difluorodeoxycytidine Drug: Docetaxel Given IV Other Names: Taxotere Docecad RP56976 Taxotere Injection Concentrate Drug: Pemetrexed Given IV Other Names: MTA Multitargeted Antifolate Pemfexy Biological: Ramucirumab Given IV Other Names: LY3009806 IMC-1121B Cyramza Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B Monoclonal Antibody HGS-ETR2 Dietary supplement: Cobalamin Given intramuscularly Other Names: Vitamin B12 B12 Vitamin Cobalamin (1+) VIT B12 Vitamin B-12 Vitamin-B12 Drug: Dexamethasone Given orally (PO) Other Names: Decadron Hemady Aacidexam Adexone Aknichthol Dexa Alba-Dex Alin Alin Depot Alin Oftalmico Amplidermis Anemul mono Auricularum Auxiloson Baycadron Baycuten Baycuten N Cortidexason Cortisumman Decacort Decadrol Decadron DP Decalix Decameth Decasone R.p. Dectancyl Dekacort Deltafluorene Deronil Desamethasone Desameton Dexa-Mamallet Dexa-Rhinosan Dexa-Scheroson Dexa-sine Dexacortal Dexacortin Dexafarma Dexafluorene Dexalocal Dexamecortin Dexameth Dexamethasone Intensol Dexamethasonum Dexamonozon Dexapos Dexinoral Dexone Dinormon Dxevo Fluorodelta Fortecortin Gammacorten Hexadecadrol Hexadrol Lokalison-F Loverine Methylfluorprednisolone Millicorten Mymethasone Orgadrone Spersadex TaperDex Visumetazone ZoDex Dietary supplement: Folic Acid Given PO Other Names: Vitamin B9 Folacin FA 2-[4-[(2-amino-4-oxo-1H-pteridin-6-yl)methylamino]benzoyl]aminopentanedioic acid Pteroylmonoglutamic Acid Vitamin Bc
Experimental: Arm B (pembrolizumab, nogapendekin alfa) Patients receive pembrolizumab IV over 30 minutes and nogapendekin alfa SC on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients then receive nogapendekin alfa SC on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Biological: Pembrolizumab Given IV Other Names: Keytruda MK-3475 Lambrolizumab SCH 900475 Drug: Nogapendekin Alfa Given SC Other Names: ALT 803 ALT-803 ALT803 Fusion Protein Consisting of IL-15N72D and IL-15RaSu/FC IL-15N72D/IL-15Ra-Fc IL-15N72D:IL-15RaSu/Fc Fusion Complex N 803 N-803 N803 Superagonist Interleukin-15:Interleukin-15 Receptor AlphaSu/Fc Fusion Complex Alt-803

Participant Group / Arm

Intervention / Treatment

Active Comparator: Arm A (standard of care)

Patients receive standard of care consisting of docetaxel IV over 30-60 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; pemetrexed IV over 10 minutes on day 1; or ramucirumab IV over 30-60 minutes and docetaxel IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: Gemcitabine

Given IV

Other Names:

dFdCyd
dFdC
Difluorodeoxycytidine

Drug: Docetaxel

Given IV

Other Names:

Taxotere
Docecad
RP56976
Taxotere Injection Concentrate

Drug: Pemetrexed

Given IV

Other Names:

MTA
Multitargeted Antifolate
Pemfexy

Biological: Ramucirumab

Given IV

Other Names:

LY3009806
IMC-1121B
Cyramza
Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B
Monoclonal Antibody HGS-ETR2

Dietary supplement: Cobalamin

Given intramuscularly

Other Names:

Vitamin B12
B12 Vitamin
Cobalamin (1+)
VIT B12
Vitamin B-12
Vitamin-B12

Drug: Dexamethasone

Given orally (PO)

Other Names:

Decadron
Hemady
Aacidexam
Adexone
Aknichthol Dexa
Alba-Dex
Alin
Alin Depot
Alin Oftalmico
Amplidermis
Anemul mono
Auricularum
Auxiloson
Baycadron
Baycuten
Baycuten N
Cortidexason
Cortisumman
Decacort
Decadrol
Decadron DP
Decalix
Decameth
Decasone R.p.
Dectancyl
Dekacort
Deltafluorene
Deronil
Desamethasone
Desameton
Dexa-Mamallet
Dexa-Rhinosan
Dexa-Scheroson
Dexa-sine
Dexacortal
Dexacortin
Dexafarma
Dexafluorene
Dexalocal
Dexamecortin
Dexameth
Dexamethasone Intensol
Dexamethasonum
Dexamonozon
Dexapos
Dexinoral
Dexone
Dinormon
Dxevo
Fluorodelta
Fortecortin
Gammacorten
Hexadecadrol
Hexadrol
Lokalison-F
Loverine
Methylfluorprednisolone
Millicorten
Mymethasone
Orgadrone
Spersadex
TaperDex
Visumetazone
ZoDex

Dietary supplement: Folic Acid

Given PO

Other Names:

Vitamin B9
Folacin
FA
2-[4-[(2-amino-4-oxo-1H-pteridin-6-yl)methylamino]benzoyl]aminopentanedioic acid
Pteroylmonoglutamic Acid
Vitamin Bc

Experimental: Arm B (pembrolizumab, nogapendekin alfa)

Patients receive pembrolizumab IV over 30 minutes and nogapendekin alfa SC on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients then receive nogapendekin alfa SC on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Biological: Pembrolizumab

Given IV

Other Names:

Keytruda
MK-3475
Lambrolizumab
SCH 900475

Drug: Nogapendekin Alfa

Given SC

Other Names:

ALT 803
ALT-803
ALT803
Fusion Protein Consisting of IL-15N72D and IL-15RaSu/FC
IL-15N72D/IL-15Ra-Fc
IL-15N72D:IL-15RaSu/Fc Fusion Complex
N 803
N-803
N803
Superagonist Interleukin-15:Interleukin-15 Receptor AlphaSu/Fc Fusion Complex Alt-803

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival Time Frame: Up to 2 years	Will be compared between the arms using the combination weighted/unweighted log-rank test statistic (as utilized in S1800A) with statistical significance at the 1-sided 10% level.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator-assessed progression-free survival (IA-PFS) Time Frame: From date of sub-study randomization to date of first documentation of potential immune-response confirmed progression, or death due to any cause, assessed up to 2 years	Will be compared between the arms using the combination weighted/unweighted log-rank test statistic (as utilized in S1800A) with statistical significance at the 1-sided 10% level.	From date of sub-study randomization to date of first documentation of potential immune-response confirmed progression, or death due to any cause, assessed up to 2 years
Duration of response (DoR) Time Frame: From date of first documentation of response (complete response or partial response) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 2 years		From date of first documentation of response (complete response or partial response) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: John M Wrangle, SWOG Cancer Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Anticipated)

February 1, 2027

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

S1800D (Other Identifier: CTEP)
U10CA180888 (U.S. NIH Grant/Contract)
NCI-2021-09852 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Stage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung... and other conditions

United States
Academic and Community Cancer Research United
National Cancer Institute (NCI)

Active, not recruiting

Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

Metastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage III Colon Cancer AJCC v8 | Stage III Rectal Cancer AJCC v8 | Stage IIIA Colon Cancer AJCC v8 | Stage IIIA Rectal Cancer AJCC v8 | Stage IIIB Colon Cancer AJCC v8 | Stage IIIB Rectal Cancer AJCC... and other conditions

United States
Roswell Park Cancer Institute

Recruiting

Single Fraction Stereotactic Body Radiation Therapy After Surgery in Treating Patients With Non-small Cell Lung Cancer

Stage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage IIIC Lung Cancer AJCC v8 | Positive Surgical Margin | Resected Mass

United States

Clinical Trials on Gemcitabine

AstraZeneca

Recruiting

Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs) (TOURMALINE)

Biliary Tract Cancer

France, Spain, Italy, Korea, Republic of, Japan, Germany, United States, Singapore
Sierra Oncology LLC - a GSK company

Completed

A Phase 1/2 Trial SRA737 in Combination With Gemcitabine and Cisplatin or Gemcitabine Alone in Advanced Cancer Subjects

Advanced Solid Tumors

Spain, United Kingdom
University of Erlangen-Nürnberg Medical School

Completed

Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy (CONKO-007)

Pancreatic Cancer

Germany
Shenzhen University General Hospital

Not yet recruiting

Comparing Astragalus Plus Gemcitabine to Gemcitabine Alone as Neoadjuvant Treatment for Pancreatic Cancer Patients

Pancreatic Cancer

China
3D Medicines (Sichuan) Co., Ltd.

Not yet recruiting

Multicenter Phase 2 Study of Envafolimab in Biliary Tract Cancers

Biliary Tract Neoplasms
Kansai Hepatobiliary Oncology Group

Completed

GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer

Biliary Tract Cancer

Japan
Fifth Affiliated Hospital, Sun Yat-Sen University

Recruiting

Gemcitabine-based Induction Chemotherapy Combined With Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma

China
3D Medicines (Sichuan) Co., Ltd.

Recruiting

Programmed Death Ligand (PD-L1) Combined With Chemotherapy for Patients With BTC (KN035-BTC)

Biliary Tract Neoplasms

China
Yung NA
Queen Mary Hospital, Hong Kong; Pamela Youde Nethersole Eastern Hospital

Recruiting

Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial

Muscle-Invasive Bladder Carcinoma | Muscle Invasive Bladder Urothelial Carcinoma

Hong Kong
Air Force Military Medical University, China

Recruiting

GNT Induction Treatment in Locally Advanced NPC

Nasopharyngeal Carcinoma

China

Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)

Study Overview

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Clinical Trials on Stage IVA Lung Cancer AJCC v8

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