RECRUITING

Study of Radiation Therapy Followed by Atezolizumab in Stage II or III Non-small Cell Lung Cancer Patients

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 trial studies the side effects of radiation therapy followed by atezolizumab in treating patients with stage II or III non-small cell lung cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more cancer cells and have fewer side effects. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to test the safety and effectiveness of radiation therapy followed by atezolizumab and find out what side effects, if any, it has on patient's non-small cell lung cancer.

Official Title

A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients With Borderline Performance Status

Quick Facts

Study Start:2021-01-13
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04310020

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. * REGISTRATION STEP 1: Participants must have pathologic (cytological or histological) proof of non-small cell lung cancer (NSCLC)
  2. * REGISTRATION STEP 1: Participants must have stage III NSCLC with Zubrod performance status of 2 or stage II NSCLC with Zubrod performance status of 0-2
  3. * REGISTRATION STEP 1: Participants must not be candidates for surgical resection in the opinion of the treating investigator. Participants whose disease was previously resected must have experienced local or regional recurrence at least 12 months after resection
  4. * REGISTRATION STEP 1: Participants must not be candidates for concurrent chemoradiation in the opinion of the treating investigator
  5. * REGISTRATION STEP 1: Participants must have measurable or non-measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to Registration Step 1. Non-measurable disease must be assessed within 42 days prior to Step 1 registration. 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)
  6. * REGISTRATION STEP 1: Participants must have an MRI or CT scan of the brain with contrast within 28 days prior to Registration Step 1
  7. * REGISTRATION STEP 1: Participants' disease must fit within the radiation constraints in the opinion of a local radiation oncologist
  8. * REGISTRATION STEP 1: Participants may have received prior treatment for their lung cancer, including surgery, chemotherapy, targeted agents, and/or radiation treatment. At least 12 months must have elapsed since last treatment
  9. * REGISTRATION STEP 1: Participants may have had prior radiation therapy as long as the irradiated area does not overlap with the radiation field targeted for this study
  10. * REGISTRATION STEP 1: Participants must have recovered from any adverse effects of prior major surgery to the satisfaction of the treating physician. Biopsies and central IV access placement are not considered major surgery
  11. * REGISTRATION STEP 1: Absolute neutrophil count (ANC) \>= 1500/mcl (obtained within 28 days prior to Registration Step 1)
  12. * REGISTRATION STEP 1: Platelet count \>= 100,000/mcl (obtained within 28 days prior to Registration Step 1)
  13. * REGISTRATION STEP 1: Hemoglobin \>= 9 grams/dL (obtained within 28 days prior to Registration Step 1)
  14. * REGISTRATION STEP 1: Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to Registration Step 1)
  15. * REGISTRATION STEP 1: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x IULN (obtained within 28 days prior to Registration Step 1)
  16. * REGISTRATION STEP 1: Serum creatinine =\< 1.5 x IULN OR measured or calculated creatinine clearance \>= 40 mL/min (obtained within 28 days prior to Registration Step 1)
  17. * REGISTRATION STEP 1: Participants must have percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO) of at least 40% documented within 90 days prior to Registration Step 1
  18. * REGISTRATION STEP 1: Patient must not have had a prior history of interstitial lung disease or \> grade 2 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5) pneumonitis
  19. * REGISTRATION STEP 1: Participants must not have active autoimmune disease requiring therapy within the past 6 months
  20. * REGISTRATION STEP 1: Participants must not have an active infection requiring therapy
  21. * REGISTRATION STEP 1: Participants must be ≥ 18 years old
  22. * REGISTRATION STEP 1: Participants must not be pregnant or nursing because atezolizumab has not been studied in pregnant or nursing women and the mechanism of action is expected to cause fetal harm. Women/men of reproductive potential must have agreed to use an effective contraceptive method while on protocol treatment and for five months after last dose of atezolizumab. 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
  23. * REGISTRATION STEP 1: Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Registration Step 1
  24. * REGISTRATION STEP 1: Patient must be tested for hepatitis B within 28 days prior to Registration Step 1. Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection. Patients may have past or resolved HBV infection. Active HBV is defined as having a positive hepatitis B surface antigen (HBsAg) test. Past or resolved HBV is defined as having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb) test
  25. * REGISTRATION STEP 1: Patients must not have active hepatitis C virus (HCV) infection. Active HCV is defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test. Patient must have an HCV antibody test within 28 days prior to Registration Step 1. If the HCV antibody test is positive, the patient must also have an HCV quantitative RNA test within 28 days prior to Registration Step 1
  26. * REGISTRATION STEP 1: 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 three years. Participants with localized prostate cancer who are being followed by an active surveillance program are also eligible
  27. * REGISTRATION STEP 1: Participants must be offered optional participation in banking of specimens for future research
  28. * REGISTRATION STEP 1: 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
  29. * REGISTRATION STEP 1: As a part of the Oncology Patient Enrollment Network (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
  30. * REGISTRATION STEP 2: Participants must be registered to Step 2 within 42 days after completion of radiation treatment. Participants must have received at least 44 Gy of radiation treatment
  31. * REGISTRATION STEP 2: Participants must have no evidence of progression per RECIST 1.1 on CT scan of the chest, abdomen, and pelvis performed between 2 and 5 weeks after completion of radiation therapy
  32. * REGISTRATION STEP 2: Any toxicities from radiation therapy must have resolved to \< grade 2
  33. * REGISTRATION STEP 2: ANC \>= 1.5 x 10\^3/uL (obtained within 28 days prior to Registration Step 2)
  34. * REGISTRATION STEP 2: Platelet count \>= 100 x 10\^3/uL (obtained within 28 days prior to Registration Step 2)
  35. * REGISTRATION STEP 2: Hemoglobin \>= 9 grams/dL (obtained within 28 days prior to Registration Step 2)
  36. * REGISTRATION STEP 2: Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to Registration Step 2)
  37. * REGISTRATION STEP 2: AST and ALT =\< 2.5 x IULN (obtained within 28 days prior to Registration Step 2)
  38. * REGISTRATION STEP 2: Serum creatinine =\< 1.5 x IULN OR measured or calculated creatinine clearance \>= 40 mL/min (obtained within 28 days prior to Registration Step 2)
  39. * REGISTRATION STEP 2: Participants must not have received steroids in doses of more than prednisone 10 mg daily or equivalent within 14 days prior to Registration Step 2
  40. * REGISTRATION STEP 2: Participants must not have received a live vaccine within 28 days prior to Registration Step 2
  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

Raid Aljumaily
PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508
United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508
United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508
United States
Alaska Women's Cancer Care
Anchorage, Alaska, 99508
United States
Katmai Oncology Group
Anchorage, Alaska, 99508
United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508
United States
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, 72401
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
United States
Porter Adventist Hospital
Denver, Colorado, 80210
United States
Littleton Adventist Hospital
Littleton, Colorado, 80122
United States
Parker Adventist Hospital
Parker, Colorado, 80138
United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180
United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140
United States
Augusta University Medical Center
Augusta, Georgia, 30912
United States
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, 30265
United States
Hawaii Cancer Care - Westridge
'Aiea, Hawaii, 96701
United States
Pali Momi Medical Center
'Aiea, Hawaii, 96701
United States
Queen's Cancer Center - Pearlridge
'Aiea, Hawaii, 96701
United States
The Cancer Center of Hawaii-Pali Momi
'Aiea, Hawaii, 96701
United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
United States
Island Urology
Honolulu, Hawaii, 96813
United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
United States
Queen's Medical Center
Honolulu, Hawaii, 96813
United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817
United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766
United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
Illinois CancerCare-Canton
Canton, Illinois, 61520
United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
United States
Centralia Oncology Clinic
Centralia, Illinois, 62801
United States
Saint Mary's Hospital
Centralia, Illinois, 62801
United States
Jesse Brown Veterans Affairs Medical Center
Chicago, Illinois, 60612
United States
University of Illinois
Chicago, Illinois, 60612
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
United States
Illinois CancerCare-Peru
Peru, Illinois, 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
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
The Carle Foundation Hospital
Urbana, Illinois, 61801
United States
Illinois CancerCare - Washington
Washington, Illinois, 61571
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
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Mission Cancer and Blood - Des Moines
Des Moines, Iowa, 50309
United States
Broadlawns Medical Center
Des Moines, Iowa, 50314
United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
United States
Mission Cancer and Blood - Laurel
Des Moines, Iowa, 50314
United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700
United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266
United States
Saint Joseph Hospital
Lexington, Kentucky, 40504
United States
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504
United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509
United States
Beverly Hospital
Beverly, Massachusetts, 01915
United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
United States
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930
United States
Lahey Medical Center-Peabody
Peabody, Massachusetts, 01960
United States
Winchester Hospital
Winchester, Massachusetts, 01890
United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671
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
Mercy Clinic-Rolla-Cancer and Hematology
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
Mercy Hospital Springfield
Springfield, Missouri, 65804
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
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
United States
Logan Health Medical Center
Kalispell, Montana, 59901
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
United States
Montefiore Medical Center-Einstein Campus
Bronx, New York, 10461
United States
Montefiore Medical Center-Weiler Hospital
Bronx, New York, 10461
United States
Montefiore Medical Center - Moses Campus
Bronx, New York, 10467
United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459
United States
Miami Valley Hospital South
Centerville, Ohio, 45459
United States
Miami Valley Hospital
Dayton, Ohio, 45409
United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409
United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415
United States
Miami Valley Hospital North
Dayton, Ohio, 45415
United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373
United States
Upper Valley Medical Center
Troy, Ohio, 45373
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
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
United States
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121
United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601
United States
UPMC Hillman Cancer Center in Greenville/UPMC Horizon
Greenville, Pennsylvania, 16125
United States
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
United States
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, 16105
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, 15215
United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
United States
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243
United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346
United States
UPMC Cancer Center-Washington
Washington, Pennsylvania, 15301
United States
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, 15301
United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, 38017
United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120
United States
Parkland Memorial Hospital
Dallas, Texas, 75235
United States
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104
United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915
United States
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield, Wisconsin, 53045
United States
Ascension Calumet Hospital
Chilton, Wisconsin, 53014
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
United States
Ascension Saint Francis - Reiman Cancer Center
Franklin, Wisconsin, 53132
United States
Ascension Southeast Wisconsin Hospital - Franklin
Franklin, Wisconsin, 53132
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097
United States
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Milwaukee, Wisconsin, 53210
United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211
United States
Ascension Saint Francis Hospital
Milwaukee, Wisconsin, 53215
United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
United States
Ascension Mercy Hospital
Oshkosh, Wisconsin, 54904
United States
Ascension All Saints Hospital
Racine, Wisconsin, 53405
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
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa, Wisconsin, 53226
United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Raid Aljumaily, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-01-13
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2021-01-13
Study Completion Date2026-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Non-Small Cell Carcinoma
  • Stage II Lung Cancer AJCC v8
  • Stage III Lung Cancer AJCC v8