Combination Treatment (Talazoparib Plus Avelumab) for Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer With STK11 Gene Mutation (A LUNG-MAP Treatment Trial)

August 14, 2024 updated by: SWOG Cancer Research Network

A Phase II Study of Talazoparib Plus Avelumab in Patients With Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer Bearing Pathogenic STK11 Genomic Alterations (LUNG-MAP Sub-Study)

This phase II LUNG-MAP treatment trial studies how well combination treatment (talazoparib plus avelumab) works in treating patients with non-squamous non-small cell lung cancer that has an STK11 gene mutation and has come back (recurrent) or is stage IV. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy drugs given as single therapies or in combination with chemotherapy do not appear to work as well in lung cancer cells with mutations in the STK11 gene versus those that do not have the mutation. Adding the medicine talazoparib to the immunotherapy drug avelumab may work better in treating lung cancers that have an STK11 gene mutation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib plus avelumab in patients with stage IV or recurrent non-squamous non-small cell lung cancer bearing pathogenic STK11 genomic alterations that were previously-treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy.

II. To evaluate disease control rate at 12 weeks (DCR12) after registration.

SECONDARY OBJECTIVES:

I. To evaluate investigator assessed progression-free survival (IA-PFS). II. To evaluate overall survival (OS). III. To evaluate duration of response (DOR) among responders. IV. To evaluate the frequency and severity of toxicities.

TRANSLATIONAL MEDICINE OBJECTIVES:

I. To collect, process, and bank cell-free deoxyribonucleic acid (DNA) (cfDNA) at baseline, cycle 3 day 1, progression, and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA) and examine molecular mechanisms of resistance to talazoparib and avelumab.

II. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC).

III. To evaluate clinical outcomes (ORR, IA-PFS, OS) in patients with concurrent somatic mutations in KEAP1 detected on the Foundation Medicine Inc. (FMI) panel from the LUNGMAP screening protocol.

IV. To evaluate clinical outcomes (ORR, IA-PFS, OS) in patients with concurrent mutations in ATM or other DNA damage response genes detected on the FMI panel from the LUNGMAP screening protocol.

V. To evaluate the association between tumor mutational burden (TMB) measured on the FMI panel from the LUNGMAP screening protocol and clinical outcomes (ORR, IA-PFS, OS).

OUTLINE:

Patients receive talazoparib orally (PO) daily and avelumab intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up until death or 3 years after sub-study registration.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

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
      • Mobile, Alabama, United States, 36688
        • University of South Alabama Mitchell Cancer Institute
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Anaheim, California, United States, 92806
        • Kaiser Permanente-Anaheim
      • 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
      • Fontana, California, United States, 92335
        • Kaiser Permanente-Fontana
      • Fremont, California, United States, 94538
        • Palo Alto Medical Foundation-Fremont
      • Fresno, California, United States, 93720
        • Kaiser Permanente-Fresno
      • 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, 90034
        • Kaiser Permanente-Cadillac
      • Mountain View, California, United States, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation Health Care
      • Panorama City, California, United States, 91402
        • Kaiser Permanente - Panorama City
      • Riverside, California, United States, 92505
        • Kaiser Permanente-Riverside
      • Roseville, California, United States, 95661
        • Kaiser Permanente-Roseville
      • 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, 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
      • San Rafael, California, United States, 94903
        • Kaiser San Rafael-Gallinas
      • 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
      • 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
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Boulder, Colorado, United States, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Denver, Colorado, United States, 80218
        • SCL Health Saint Joseph Hospital
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Denver, Colorado, United States, 80206
        • National Jewish Health-Main Campus
      • Englewood, Colorado, United States, 80113
        • Mountain Blue Cancer Care Center - Swedish
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Golden, Colorado, United States, 80401
        • National Jewish Health-Western Hematology Oncology
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Lafayette, Colorado, United States, 80026
        • Good Samaritan Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Loveland, Colorado, United States, 80539
        • McKee Medical Center
      • Thornton, Colorado, United States, 80260
        • National Jewish Health-Northern Hematology Oncology
      • Wheat Ridge, Colorado, United States, 80033
        • SCL Health Lutheran Medical Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • Trumbull, Connecticut, United States, 06611
        • Smilow Cancer Hospital Care Center-Trumbull
      • West Haven, Connecticut, United States, 06516
        • Veterans Affairs Connecticut Healthcare System-West Haven Campus
    • Delaware
      • Dover, Delaware, United States, 19901
        • Bayhealth Hospital Kent Campus
      • Milford, Delaware, United States, 19963
        • Bayhealth Hospital Sussex Campus
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
      • Weston, Florida, United States, 33331
        • Cleveland Clinic-Weston
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer and Blood Center LLC
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Braselton, Georgia, United States, 30517
        • Northeast Georgia Medical Center Braselton
      • Duluth, Georgia, United States, 30096
        • Northside Hospital - Duluth
      • Lawrenceville, Georgia, United States, 30046
        • Northside Hospital - Gwinnett
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Snellville, Georgia, United States, 30078
        • Suburban Hematology Oncology Associates - Snellville
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Hawaii Cancer Care - Savio
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care Inc-POB II
    • Idaho
      • Boise, Idaho, United States, 83712
        • Saint Luke's Mountain States Tumor Institute
      • Coeur d'Alene, Idaho, United States, 83814
        • Kootenai Medical Center
      • Fruitland, Idaho, United States, 83619
        • Saint Luke's Mountain States Tumor Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Saint Luke's Mountain States Tumor Institute - Meridian
      • Nampa, Idaho, United States, 83686
        • Saint Luke's Mountain States Tumor Institute - Nampa
      • Post Falls, Idaho, United States, 83854
        • Kootenai Cancer Center
      • Sandpoint, Idaho, United States, 83864
        • Kootenai Cancer Clinic
      • Twin Falls, Idaho, United States, 83301
        • Saint Luke's Mountain States Tumor 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
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • 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
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • New Lenox, Illinois, United States, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • Orland Park, Illinois, United States, 60462
        • University of Chicago Medicine-Orland Park
      • 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
      • Silvis, Illinois, United States, 61282
        • Genesis Cancer Center - Silvis
      • 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
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Regional Medical Center
      • Goshen, Indiana, United States, 46526
        • Goshen Center for Cancer Care
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Health Indianapolis
      • Mooresville, Indiana, United States, 46158
        • Franciscan Health Mooresville
      • 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
      • Boone, Iowa, United States, 50036
        • McFarland Clinic PC-Boone
      • 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
      • Davenport, Iowa, United States, 52803
        • Genesis Medical Center - East Campus
      • Davenport, Iowa, United States, 52804
        • Genesis Cancer Care Institute
      • Davenport, Iowa, United States, 52807
        • Iowa Cancer Specialists
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates-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
      • Overland Park, Kansas, United States, 66210
        • University of Kansas Cancer Center-Overland Park
      • 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
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky/Markey Cancer Center
      • Lexington, Kentucky, United States, 40509
        • Saint Joseph Hospital East
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70816
        • Medical Center of Baton Rouge
      • Baton Rouge, Louisiana, United States, 70836
        • Ochsner High Grove
      • Kenner, Louisiana, United States, 70065
        • Ochsner Medical Center Kenner
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center Jefferson
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Western Maryland Regional Medical Center
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital and Medical Center
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center - University Campus
    • Michigan
      • 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
      • Canton, Michigan, United States, 48188
        • Saint Joseph Mercy Canton
      • Canton, Michigan, United States, 48188
        • IHA Hematology Oncology Consultants-Canton
      • Chelsea, Michigan, United States, 48118
        • Saint Joseph Mercy Chelsea
      • Chelsea, Michigan, United States, 48118
        • IHA Hematology Oncology Consultants-Chelsea
      • Clinton Township, Michigan, United States, 48038
        • Henry Ford Macomb Hospital-Clinton Township
      • Detroit, Michigan, United States, 48202
        • Henry Ford 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
        • 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
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health at Butterworth Campus
      • 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
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Michigan Breast Specialists-Grosse Pointe Woods
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Lansing, Michigan, United States, 48912
        • Sparrow Hospital
      • Livonia, Michigan, United States, 48154
        • Saint Mary Mercy Hospital
      • Livonia, Michigan, United States, 48154
        • Hope Cancer Clinic
      • Macomb, Michigan, United States, 48044
        • Great Lakes Cancer Management Specialists-Macomb Medical Campus
      • Muskegon, Michigan, United States, 49444
        • Mercy Health Mercy Campus
      • Norton Shores, Michigan, United States, 49444
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Reed City, Michigan, United States, 49677
        • Spectrum Health Reed City Hospital
      • Rochester Hills, Michigan, United States, 48309
        • Great Lakes Cancer Management Specialists-Rochester Hills
      • 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
      • Tawas City, Michigan, United States, 48764
        • Ascension Saint Joseph Hospital
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
      • Warren, Michigan, United States, 48093
        • Great Lakes Cancer Management Specialists-Macomb Professional Building
      • Wyoming, Michigan, United States, 49519
        • Metro Health Hospital
      • Ypsilanti, Michigan, United States, 48197
        • IHA Hematology Oncology Consultants-Ann Arbor
    • 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
      • Hibbing, Minnesota, United States, 55746
        • Essentia Health Hibbing Clinic
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Medical Center
      • 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, 63141
        • Mercy Hospital Saint Louis
      • Saint Louis, Missouri, United States, 63128
        • Mercy Hospital South
      • Saint Louis, Missouri, United States, 63129
        • Siteman Cancer Center-South County
      • Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Sainte Genevieve, Missouri, United States, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • 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
      • Great Falls, Montana, United States, 59405
        • Benefis Healthcare- Sletten Cancer Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • OptumCare Cancer Care at Fort Apache
      • Las Vegas, Nevada, United States, 89102
        • OptumCare Cancer Care at Oakey
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • New Hampshire Oncology Hematology PA-Concord
      • Manchester, New Hampshire, United States, 03103
        • Solinsky Center for Cancer Care
    • New Jersey
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
      • Moorestown, New Jersey, United States, 08057
        • Virtua Samson Cancer Center
      • Somerville, New Jersey, United States, 08876
        • Robert Wood Johnson University Hospital Somerset
      • 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
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Cooperstown, New York, United States, 13326
        • Mary Imogene Bassett Hospital
      • Elmira, New York, United States, 14905
        • Arnot Ogden Medical Center/Falck Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27705
        • Durham VA Medical Center
      • Hendersonville, North Carolina, United States, 28791
        • Margaret R Pardee Memorial Hospital
    • 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
      • Beachwood, Ohio, United States, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Belpre, Ohio, United States, 45714
        • Strecker Cancer Center-Belpre
      • Chardon, Ohio, United States, 44024
        • Geauga Hospital
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center/Fairview 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
      • Elyria, Ohio, United States, 44035
        • Mercy Cancer Center-Elyria
      • Mansfield, Ohio, United States, 44906
        • Cleveland Clinic Cancer Center Mansfield
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Marion, Ohio, United States, 43302
        • OhioHealth Marion General Hospital
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Hospital Cancer Center
      • Mayfield Heights, Ohio, United States, 44124
        • UH Seidman Cancer Center at Landerbrook Health Center
      • Mentor, Ohio, United States, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Middleburg Heights, Ohio, United States, 44130
        • UH Seidman Cancer Center at Southwest General Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Parma, Ohio, United States, 44129
        • University Hospitals Parma Medical Center
      • Portsmouth, Ohio, United States, 45662
        • Southern Ohio Medical Center
      • Ravenna, Ohio, United States, 44266
        • University Hospitals Portage Medical Center
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care
      • Sandusky, Ohio, United States, 44870
        • UH Seidman Cancer Center at Firelands Regional Medical Center
      • Strongsville, Ohio, United States, 44136
        • Cleveland Clinic Cancer Center Strongsville
      • Sylvania, Ohio, United States, 43560
        • ProMedica Flower Hospital
      • Wadsworth, Ohio, United States, 44281
        • University Hospitals Sharon Health Center
      • Warrensville Heights, Ohio, United States, 44122
        • South Pointe Hospital
      • Westlake, Ohio, United States, 44145
        • UH Seidman Cancer Center at Saint John Medical Center
      • Westlake, Ohio, United States, 44145
        • UHHS-Westlake Medical Center
      • 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
      • 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, 97227
        • Kaiser Permanente Northwest
      • Salem, Oregon, United States, 97301
        • Salem Hospital
    • Pennsylvania
      • Ephrata, Pennsylvania, United States, 17522
        • Ephrata Cancer Center
      • Gettysburg, Pennsylvania, United States, 17325
        • Adams Cancer Center
      • Hanover, Pennsylvania, United States, 17331
        • Cherry Tree Cancer Center
      • Harrisburg, Pennsylvania, United States, 17109
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
      • Lebanon, Pennsylvania, United States, 17042
        • Sechler Family Cancer Center
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
      • Pottstown, Pennsylvania, United States, 19464
        • Pottstown Hospital
      • Williamsport, Pennsylvania, United States, 17701
        • UPMC Susquehanna
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Cancer Center
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Cancer 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
      • Greer, South Carolina, United States, 29650
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, United States, 29672
        • Prisma Health Cancer Institute - Seneca
      • Spartanburg, South Carolina, United States, 29307
        • Prisma Health Cancer Institute - Spartanburg
    • 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
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • Centra Lynchburg Hematology-Oncology Clinic Inc
      • Richmond, Virginia, United States, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
      • South Hill, Virginia, United States, 23970
        • VCU Community Memorial Health Center
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology PC
    • Washington
      • Port Townsend, Washington, United States, 98368
        • Jefferson Healthcare
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Edwards Comprehensive Cancer Center
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Langlade Hospital and Cancer Center
      • Ashland, Wisconsin, United States, 54806
        • Duluth Clinic Ashland
      • Burlington, Wisconsin, United States, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Germantown, Wisconsin, United States, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, United States, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • 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
      • Kenosha, Wisconsin, United States, 53142
        • Aurora Cancer Care-Kenosha South
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Marinette, Wisconsin, United States, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Medford, Wisconsin, United States, 54451
        • Aspirus Medford Hospital
      • Menomonee Falls, Wisconsin, United States, 53051
        • Froedtert Menomonee Falls Hospital
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Aurora Cancer Care-Milwaukee
      • 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
      • Oshkosh, Wisconsin, United States, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine, Wisconsin, United States, 53406
        • Aurora Cancer Care-Racine
      • Sheboygan, Wisconsin, United States, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • 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
      • Two Rivers, Wisconsin, United States, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center
      • 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
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Aspirus UW 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

No

Description

Inclusion Criteria:

  • Patients must be assigned to S1900C. Assignment to S1900C is determined by the LUNGMAP protocol genomic profiling using the FoundationOne assay. Biomarker eligibility for S1900C is based on the identification of a pathogenic somatic mutation in STK11 or STK11 bi-allelic loss on tumor
  • Patients must have histologically or cytologically confirmed stage IV or recurrent non-squamous, mixed squamous/non-squamous (e.g., adeno-squamous carcinoma), or non-small cell lung cancer not otherwise specified (NSCLC NOS). Patients with pure squamous cell carcinoma are not eligible
  • Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to sub-study registration
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to sub-study registration
  • Patients with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to sub-study registration

  • Patients must have received at least one line of anti-PD-1 or anti-PD-L1 therapy for stage III, IV or recurrent disease. Any number of additional, non-platinum-based chemotherapy or targeted therapy regimens for recurrent or metastatic disease are allowed

    • Patients may not have received more than one line of anti-PD-1 or anti-PD-L1 therapy in the Stage IV or recurrent setting. Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with platinum-based chemotherapy, an anti-CTLA4 therapy, or other immune-modulatory therapy. Patients must have experienced disease progression > 42 days following initiation (cycle 1 day 1) of the anti-PD-1 or anti-PD-L1 containing regimen
    • Patients who did not receive anti-PD-1 or anti-PD-L1 therapy in combination with platinum-based chemotherapy, must have also received prior platinum-based chemotherapy and experienced disease progression > 42 days following initiation (cycle 1 day 1) of platinum based chemotherapy
    • Patients who received 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, are eligible if they experienced disease progression less than (<) 365 days from the date of initiation of anti-PD-1 or anti-PD-L1 therapy
  • Patients who received prior adjuvant platinum-based therapy post-surgical resection for stage I-III disease (i.e. the patient has not received platinum-based chemotherapy for Stage IV or recurrent disease) must have had disease progression during or after platinum-based chemotherapy that occurred less than (<) 365 days from the last date that the patient received that therapy
  • Patients must be able to swallow capsules whole
  • Patients must not have had prior exposure to any agent with a PARP inhibitor (e.g., veliparib, olaparib, rucaparib, niraparib, talazoparib) as its primary pharmacology
  • Patients must not be taking, nor plan to take while on protocol treatment strong P-glycoprotein (P-gp) inhibitors (e.g. dronedarone, quinidine, ranolazine, itraconazole, ketoconazole), P-gp inducers (rifampin, ritonavir, tipranavir), or strong breast cancer resistance protein (BCRP) inhibitors (e.g. elacridar)
  • Patients must have progressed following their most recent line of therapy
  • Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration. Patients must have recovered (=< grade 1) from any side effects of prior therapy. Patients must not have received any radiation therapy within 14 days prior to sub-study registration
  • Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable
  • Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to sub-study registration. CT and MRI scans must be submitted for central review via Transfer of Images and Data (TRIAD)
  • Patients 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 registration. Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to sub-study registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration
  • Patient must not have had a major surgery within 14 days prior to sub-study registration. Patient must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
  • Serum bilirubin =< institutional upper limit of normal (IULN) (within 28 days prior to sub-study registration). For patients with liver metastases, bilirubin must be =< 5 x IULN
  • Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN within 28 days prior to sub-study registration (if both ALT and AST are done, both must be =< 2 IULN). For patients with liver metastases, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)
  • Patients must have a serum creatinine =< the IULN or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to sub-study registration
  • Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration
  • Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients 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, or serious uncontrolled cardiac arrhythmia
  • Pre-study history and physical exam must be obtained within 28 days prior to sub-study registration
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to sub-study registration). Patients must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to sub-study registration)
  • Platelet count >= 100,000 mcl (obtained within 28 days prior to sub-study registration). Patients must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to sub-study registration)
  • Hemoglobin >= 9 g/dL (obtained within 28 days prior to sub-study registration). Patients must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to sub-study registration)
  • Patients must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
  • Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens

Exclusion Criteria:

  • Patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method. 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 patient 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
  • Patients must not have a history of prior organ transplantation, including allogeneic stem-cell transplantation
  • Patients 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 registration. Inhaled or topical steroids, and adrenal replacement doses =< 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease
  • Patients must not have active autoimmune disease that requires systemic steroids (equivalent of > 10 mg of prednisone) or immunosuppressive agents within 7 days prior to sub-study registration (for example disease-modifying anti-rheumatic drugs). Exceptions include: patients with controlled type 1 diabetes mellitus, controlled hypo- or hyperthyroidism, vitiligo, resolved childhood asthma/atopy, or psoriasis not requiring immunosuppressive therapy
  • Patients must not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of talazoparib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or active peptic ulcer disease). Patients must not have active small or large intestine inflammation such as Crohn's disease or ulcerative colitis within 12 months prior to sub-study registration
  • Patients must not have known prior or suspected hypersensitivity to monoclonal antibodies (grade >= 3)

  • Patients must not have any history of anaphylaxis or uncontrolled asthma. Uncontrolled asthma is defined as a patient having any one of the following criteria:

    • Poor symptom control: Asthma Control Questionnaire (ACQ) consistently > 1.5 or Asthma Control Test Questionnaire (ACT) < 20 (or "not well controlled" by National Asthma Education and Prevention Program [NAEPP] or Global Initiative for Asthma [GINA] guidelines over the 3 months or evaluation)
    • Frequent severe exacerbations: 2 or more bursts of systemic corticosteroids (CSs) (> 3 days each) in the previous year
    • Serious exacerbations: at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous year
    • Airflow limitation: Forced expiratory volume in 1 second (FEV1) < 80% predicted (in the presence of reduced FEV1/forced vital capacity [FVC] defined as less than the normal lower limit) following a withhold of both short- and long-acting bronchodilators
  • Patients must not have experienced any immune related adverse event, including pneumonitis that led to permanent discontinuation of prior immunotherapy and/or required prolonged high dose of steroids
  • Patients must not have evidence of active infection requiring systemic therapy
  • Patients must not have received any live attenuated vaccinations within 28 days prior to sub-study registration

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (talazoparib, avelumab)
Patients receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Avelumab
Given IV
Other Names:
  • Bavencio
  • MSB-0010718C
  • MSB0010718C
Drug: Talazoparib Tosylate
Given PO
Other Names:
  • Talzenna
Drug: Talazoparib
Given PO
Other Names:
  • BMN 673
  • BMN-673

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: From date of registration to progression or treatment discontinuation, up to 1 year and 9 months

Percentage of participants with confirmed or unconfirmed, complete or partial response to treatment with talazoparib plus avelumab per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.

Complete Response (CR): Complete disappearance of all target and non-target lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to < 1.0 cm. All disease must be assessed using the same technique as baseline.

Partial Response (PR): Applies only to participants with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.
From date of registration to progression or treatment discontinuation, up to 1 year and 9 months
Disease Control Rate at 12 Weeks (DCR12)
Time Frame: 12 weeks after registration
Percentage of participants with a best response of Complete Response (CR), Partial Response (PR), Unconfirmed Partial Response (UPR), or Unconfirmed Complete Response (UCR) by/at the second disease assessment at 12 weeks after registration (+/- 2 weeks), or stable disease at 12 weeks after registration (+/- 2 weeks). Participants with missing or delayed disease assessment at 12 weeks (+/- 2 weeks), at or before the disease assessment at 20 weeks (+/- 2 weeks) with documented lack of progression (CR, PR, UPR, UCR, or stable) were coded as having disease control at 12 weeks. Participants not known to have disease control at 12 weeks who have at least 12 weeks of follow-up were coded as not having disease control at 12 weeks.
12 weeks after registration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator-Assessed Progression-Free Survival (IA-PFS)
Time Frame: From date of registration to a maximum of 3 years or death

From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause. Participants last known to be alive without report of progression are censored at date of last disease assessment. For participants with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan (as defined by the disease assessment schedule) is used as the date of progression.

Progression is defined as: 20% increase in the sum of appropriate diameters of target lesions and absolute increase of at least 0.5 cm, or unequivocal progression of non-measurable disease, or appearance of any new lesion/site, or death from disease without prior documentation of progression or symptomatic deterioration.

Symptomatic deterioration: Global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
From date of registration to a maximum of 3 years or death
Overall Survival (OS)
Time Frame: From date of registration to a maximum of 3 years or death
From date of sub-study registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact.
From date of registration to a maximum of 3 years or death
Duration of Response (DOR)
Time Frame: From date of registration to a maximum of 3 years or death

From date of first response to first progression assessed by local review or symptomatic deterioration, or death among patients with a response (CR or PR). Those last known to be alive without progression are censored at date of last disease assessment. For those with a missing scan whose next scan shows progression, expected date of the first missing scan is used as progression date.

Complete Response (CR): Disappearance of all target and non-target lesions. No new lesions or disease related symptoms. Lymph nodes must have reduction in short axis to < 1.0cm. Assessed using same technique as baseline.

Partial Response (PR): At least 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Assessed using same technique as baseline.

Symptomatic deterioration: Global deterioration of health status requiring discontinuation of treatment w/o objective evidence of progression.
From date of registration to a maximum of 3 years or death
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Time Frame: Duration of treatment and follow up until death or 3 years post registration
Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 5.0 was used for routine toxicity reporting and serious adverse events (SAEs).
Duration of treatment and follow up until death or 3 years post registration

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: Ferdinandos Skoulidis, 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)

February 14, 2020

Primary Completion (Actual)

November 24, 2021

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

November 20, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 22, 2019

Study Record Updates

Last Update Posted (Actual)

September 3, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S1900C (Other Identifier: CTEP)
  • U10CA180888 (U.S. NIH Grant/Contract)
  • NCI-2019-07142 (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

No

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.

Clinical Trials on Stage IVA Lung Cancer AJCC v8

Clinical Trials on Avelumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe