RECRUITING

Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) versus (vs.) usual treatment alone in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.

Official Title

A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without Radiation Therapy for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

Quick Facts

Study Start:2022-10-07
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04929041

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologic or cytologic diagnosis of stage IV NSCLC using version American Joint Committee on Cancer (AJCC) 8th edition (includes M1a, M1b, and M1c stage disease). Patients with stage IIIB and IIIC disease are eligible if they are not a candidate for combined chemotherapy and radiation
  2. * PD-L1 expression tumor proportion score (TPS) \< 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed patients are not eligible. The assay must have been performed locally by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory. The type of assay will be recorded
  3. * For non-squamous patients only (adenocarcinoma or adenosquamous): EGFR, ALK and ROS1 testing must be done locally. No patients with known actionable EGFR mutations (except exon 20 insertion), ALK or ROS1 mutations that can be treated with oral tyrosine inhibitors
  4. * Measurable disease based on RECIST 1.1, including at least two cancerous deposits. At least one deposit must be RECIST measurable (and not to be irradiated) while at least one OTHER deposit (measurable or non-measurable) must meet criteria for three 8 gray (Gy) doses of radiation
  5. * Age \>= 18 years
  6. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  7. * No more than three weeks of treatment with systemic chemotherapy or immunotherapy for advanced NSCLC
  8. * No more than three weeks of treatment with checkpoint inhibitors for metastatic lung cancer
  9. * No treatment with chemotherapy or immunotherapy for non-metastatic disease (e.g., adjuvant therapy) within 6 months prior to registration
  10. * No systemic immunostimulatory or immunosuppressive drugs, including \> 10 mg prednisone equivalent per day, within 2 weeks or 5 half-live of the drug, whichever is shorter. Steroid premedication per local standard is allowed
  11. * \>= 1 week prior to registration since palliative (including central nervous system \[CNS\]) radiotherapy to any tumor site
  12. * No prior allogeneic tissue/solid organ transplant
  13. * No uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements
  14. * No current pneumonitis or history of non-infectious pneumonitis that required steroids
  15. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration
  16. * No active auto-immune disease that requires systemic therapy within 2 years prior to registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
  17. * No known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection
  18. * No patients with symptomatic central nervous system metastases and/or carcinomatous meningitis. Patients with small asymptomatic brain metastases are eligible as are patients with treated brain metastases that require no steroids
  19. * Not pregnant and not nursing, because this study involves radiation as well as potentially chemotherapy which have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 7 days prior to registration is required
  20. * No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 2 years. Participants with non-melanoma skin cancers or carcinoma in-situ (e.g., breast carcinoma, urothelial carcinoma or cervical cancer in situ) or localized prostate cancer (T1-3, N0, M0) that have undergone potentially curative therapy are eligible
  21. * No hypersensitivity (\>= grade 3) to immunotherapy and/or any of its excipients
  22. * No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed. COVID-19 vaccine is allowed
  23. * Absolute neutrophil count (ANC) \>= 1,500/mm\^3
  24. * Platelet count \>= 100,000/mm\^3
  25. * Calculated (Calc.) creatinine clearance \>= 45 mL/min
  26. * Total bilirubin =\< 1.5 x upper limit of normal (ULN)
  27. * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Christine M Bestvina
PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology

Study Locations (Sites)

Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
City of Hope at Irvine Lennar
Irvine, California, 92618
United States
City of Hope Antelope Valley
Lancaster, California, 93534
United States
Fremont - Rideout Cancer Center
Marysville, California, 95901
United States
Memorial Medical Center
Modesto, California, 95355
United States
Providence Queen of The Valley
Napa, California, 94558
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
City of Hope South Pasadena
South Pasadena, California, 91030
United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161
United States
City of Hope Upland
Upland, California, 91786
United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
United States
Memorial Hospital North
Colorado Springs, Colorado, 80920
United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524
United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631
United States
Medical Center of the Rockies
Loveland, Colorado, 80538
United States
Beebe South Coastal Health Campus
Millville, Delaware, 19967
United States
Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
United States
Morton Plant Hospital
Clearwater, Florida, 33756
United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146
United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176
United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
United States
Winter Haven Hospital
Winter Haven, Florida, 33881
United States
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, 30265
United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Illinois
Chicago, Illinois, 60612
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451
United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462
United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Springfield Memorial Hospital
Springfield, Illinois, 62781
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
United States
Mary Greeley Medical Center
Ames, Iowa, 50010
United States
McFarland Clinic - Ames
Ames, Iowa, 50010
United States
Mission Cancer and Blood - Ankeny
Ankeny, Iowa, 50023
United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
United States
Mission Cancer and Blood - West Des Moines
Clive, Iowa, 50325
United States
Greater Regional Medical Center
Creston, Iowa, 50801
United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
United States
Mission Cancer and Blood - Laurel
Des Moines, Iowa, 50314
United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266
United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
United States
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073
United States
Maine Medical Center- Scarborough Campus
Scarborough, Maine, 04074
United States
Maine Medical Partners - South Portland
South Portland, Maine, 04106
United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
United States
Chelsea Hospital
Chelsea, Michigan, 48118
United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, 48341
United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601
United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604
United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764
United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805
United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640
United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401
United States
Missouri Baptist Medical Center
Saint Louis, Missouri, 63131
United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670
United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080
United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
United States
Mount Sinai Chelsea
New York, New York, 10011
United States
Mount Sinai West
New York, New York, 10019
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Manhattan Eye Ear and Throat Hospital
New York, New York, 10065
United States
Lenox Hill Hospital
New York, New York, 10075
United States
Upstate Cancer Center at Oswego
Oswego, New York, 13126
United States
State University of New York Upstate Medical University
Syracuse, New York, 13210
United States
SUNY Upstate Medical Center-Community Campus
Syracuse, New York, 13215
United States
Upstate Cancer Center at Verona
Verona, New York, 13478
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Duke Raleigh Hospital
Raleigh, North Carolina, 27609
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Summa Health System - Akron Campus
Akron, Ohio, 44304
United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
United States
Penn State Health Saint Joseph Medical Center
Reading, Pennsylvania, 19605
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304
United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
United States
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Christine M Bestvina, PRINCIPAL_INVESTIGATOR, Alliance for Clinical Trials in Oncology

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 Registration Dates

Study Start Date2022-10-07
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2022-10-07
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Adenocarcinoma
  • Lung Adenosquamous Carcinoma
  • Lung Non-Small Cell Carcinoma
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8