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Studie van bestralingstherapie gevolgd door atezolizumab bij patiënten met stadium II of III niet-kleincellige longkanker

10 november 2026 bijgewerkt door: National Cancer Institute (NCI)

Een pilootstudie van gehypofractioneerde radiotherapie gevolgd door atezolizumab-consolidatie bij stadium II of III NSCLC-patiënten met borderline-prestatiestatus

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

PRIMARY OBJECTIVE:

I. To evaluate the rate of grade 3-5 treatment-related adverse events (TRAEs) in patients who are not candidates for surgery or concurrent chemoradiation and who have either performance status 0-2 and stage II or performance status 2 and stage III non-small cell lung cancer (NSCLC), treated with hypofractionated thoracic radiotherapy followed by atezolizumab.

SECONDARY OBJECTIVES:

I. To evaluate response rate (confirmed and unconfirmed, complete and partial by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) from Registration Step 2 in the subset of patients with measurable disease.

II. To evaluate response rate (confirmed and unconfirmed, complete and partial by RECIST 1.1) during radiation therapy in the subset of patients with measurable disease.

III. To evaluate progression free survival (PFS) from Registration Step 2 by RECIST 1.1.

IV. To evaluate overall survival (OS) from Registration Step 2. V. To evaluate the frequency and severity of toxicities.

ADDITIONAL OBJECTIVE:

I. To bank blood and archival tissue for future research.

OUTLINE:

RADIATION THERAPY: Patients undergo hypofractionated radiation therapy 5 days per week over 3 weeks for 15 fractions in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months (maximum of 17 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan and may undergo magnetic resonance imaging (MRI) throughout the study, as well as blood sample collection on study.

After completion of study treatment, patients are followed up at 6 weeks, every 12 months for the 1 year, then every 6 months until 3 years after study start.

Studietype

Ingrijpend

Inschrijving (Geschat)

47

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Alabama
      • Birmingham, Alabama, Verenigde Staten, 35233
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, Verenigde Staten, 98508
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, Verenigde Staten, 99508
        • Providence Alaska Medical Center
    • Arkansas
      • Jonesboro, Arkansas, Verenigde Staten, 72401
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    • California
      • Sacramento, California, Verenigde Staten, 95817
        • University of California Davis Comprehensive Cancer Center
    • Colorado
      • Denver, Colorado, Verenigde Staten, 80210
        • AdventHealth Porter
      • Littleton, Colorado, Verenigde Staten, 80122
        • AdventHealth Littleton
      • Parker, Colorado, Verenigde Staten, 80138
        • AdventHealth Parker
    • Florida
      • Aventura, Florida, Verenigde Staten, 33180
        • Mount Sinai Comprehensive Cancer Center at Aventura
      • Miami Beach, Florida, Verenigde Staten, 33140
        • Mount Sinai Medical Center
    • Georgia
      • Augusta, Georgia, Verenigde Staten, 30912
        • Augusta University Medical Center
      • Newnan, Georgia, Verenigde Staten, 30265
        • CTCA at Southeastern Regional Medical Center
    • Hawaii
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Verenigde Staten, 96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, Verenigde Staten, 96817
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, Verenigde Staten, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, Verenigde Staten, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, Verenigde Staten, 96813
        • Island Urology
      • Lihue, Hawaii, Verenigde Staten, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • ‘Aiea, Hawaii, Verenigde Staten, 96701
        • Hawaii Cancer Care - Westridge
      • ‘Aiea, Hawaii, Verenigde Staten, 96701
        • Pali Momi Medical Center
      • ‘Aiea, Hawaii, Verenigde Staten, 96701
        • Queen's Cancer Center - Pearlridge
      • ‘Aiea, Hawaii, Verenigde Staten, 96701
        • The Cancer Center of Hawaii-Pali Momi
    • Idaho
      • Nampa, Idaho, Verenigde Staten, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
    • Illinois
      • Bloomington, Illinois, Verenigde Staten, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, Verenigde Staten, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, Verenigde Staten, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, Verenigde Staten, 62801
        • Centralia Oncology Clinic
      • Centralia, Illinois, Verenigde Staten, 62801
        • Saint Mary's Hospital
      • Chicago, Illinois, Verenigde Staten, 60612
        • University of Illinois
      • Chicago, Illinois, Verenigde Staten, 60612
        • Jesse Brown Veterans Affairs Medical Center
      • Danville, Illinois, Verenigde Staten, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, Verenigde Staten, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Verenigde Staten, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Effingham, Illinois, Verenigde Staten, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, Verenigde Staten, 62401
        • Carle Physician Group-Effingham
      • Eureka, Illinois, Verenigde Staten, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, Verenigde Staten, 61401
        • Illinois CancerCare-Galesburg
      • Kewanee, Illinois, Verenigde Staten, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, Verenigde Staten, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, Verenigde Staten, 61938
        • Carle Physician Group-Mattoon/Charleston
      • O'Fallon, Illinois, Verenigde Staten, 62269
        • Cancer Care Center of O'Fallon
      • O'Fallon, Illinois, Verenigde Staten, 62269
        • HSHS Saint Elizabeth's Hospital
      • Ottawa, Illinois, Verenigde Staten, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, Verenigde Staten, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, Verenigde Staten, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Verenigde Staten, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, Verenigde Staten, 61354
        • Illinois CancerCare-Peru
      • Princeton, Illinois, Verenigde Staten, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, Verenigde Staten, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, Verenigde Staten, 62702
        • Springfield Clinic
      • Springfield, Illinois, Verenigde Staten, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, Verenigde Staten, 61801
        • Carle Cancer Center
      • Urbana, Illinois, Verenigde Staten, 61801
        • The Carle Foundation Hospital
      • Washington, Illinois, Verenigde Staten, 61571
        • Illinois CancerCare - Washington
    • Iowa
      • Ames, Iowa, Verenigde Staten, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, Verenigde Staten, 50010
        • McFarland Clinic - Ames
      • Ankeny, Iowa, Verenigde Staten, 50023
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
      • Clive, Iowa, Verenigde Staten, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, Verenigde Staten, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Creston, Iowa, Verenigde Staten, 50801
        • Greater Regional Medical Center
      • Des Moines, Iowa, Verenigde Staten, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Verenigde Staten, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Verenigde Staten, 50314
        • Broadlawns Medical Center
      • Des Moines, Iowa, Verenigde Staten, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, Verenigde Staten, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines, Iowa, Verenigde Staten, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
      • Waukee, Iowa, Verenigde Staten, 50263
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
      • West Des Moines, Iowa, Verenigde Staten, 50266-7700
        • Methodist West Hospital
      • West Des Moines, Iowa, Verenigde Staten, 50266
        • Mercy Medical Center-West Lakes
    • Kentucky
      • Lexington, Kentucky, Verenigde Staten, 40504
        • Saint Joseph Radiation Oncology Resource Center
      • Lexington, Kentucky, Verenigde Staten, 40509
        • CommonSpirit Saint Joseph Medical Center - East Lexington
      • Lexington, Kentucky, Verenigde Staten, 40504
        • CommonSpirit Saint Joseph Hospital - Lexington
    • Massachusetts
      • Beverly, Massachusetts, Verenigde Staten, 01915
        • Beverly Hospital
      • Burlington, Massachusetts, Verenigde Staten, 01805
        • Lahey Clinic
      • Gloucester, Massachusetts, Verenigde Staten, 01930
        • Addison Gilbert Hospital
      • Peabody, Massachusetts, Verenigde Staten, 01960
        • Lahey Clinic Peabody
      • Winchester, Massachusetts, Verenigde Staten, 01890
        • Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
    • Michigan
      • Novi, Michigan, Verenigde Staten, 48374
        • Henry Ford Health Providence Novi Hospital
      • Southfield, Michigan, Verenigde Staten, 48075
        • Henry Ford Health Providence Southfield Hospital
    • Minnesota
      • Edina, Minnesota, Verenigde Staten, 55435
        • Fairview Southdale Hospital
      • Minneapolis, Minnesota, Verenigde Staten, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Verenigde Staten, 55454
        • Health Partners Inc
      • Saint Paul, Minnesota, Verenigde Staten, 55101
        • Regions Hospital
      • Stillwater, Minnesota, Verenigde Staten, 55082
        • Lakeview Hospital
    • Mississippi
      • Southhaven, Mississippi, Verenigde Staten, 38671
        • Baptist Memorial Hospital and Cancer Center-Desoto
    • Missouri
      • Cape Girardeau, Missouri, Verenigde Staten, 63703
        • Saint Francis Medical Center
      • Farmington, Missouri, Verenigde Staten, 63640
        • Parkland Health Center - Farmington
      • Rolla, Missouri, Verenigde Staten, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Verenigde Staten, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Sainte Genevieve, Missouri, Verenigde Staten, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, Verenigde Staten, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Verenigde Staten, 63131
        • Missouri Baptist Medical Center
      • Sullivan, Missouri, Verenigde Staten, 63080
        • Missouri Baptist Sullivan Hospital
    • Montana
      • Bozeman, Montana, Verenigde Staten, 59715
        • Bozeman Health Deaconess Hospital
      • Great Falls, Montana, Verenigde Staten, 59405
        • Benefis Sletten Cancer Institute
      • Kalispell, Montana, Verenigde Staten, 59901
        • Logan Health Medical Center
    • New Mexico
      • Albuquerque, New Mexico, Verenigde Staten, 87106
        • University of New Mexico Cancer Center
    • New York
      • The Bronx, New York, Verenigde Staten, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, Verenigde Staten, 10467
        • Montefiore Medical Center - Moses Campus
      • The Bronx, New York, Verenigde Staten, 10461
        • Montefiore Medical Center-Weiler Hospital
    • Ohio
      • Centerville, Ohio, Verenigde Staten, 45459
        • Miami Valley Hospital South
      • Centerville, Ohio, Verenigde Staten, 45459
        • Dayton Physicians LLC-Miami Valley South
      • Dayton, Ohio, Verenigde Staten, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Verenigde Staten, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, Verenigde Staten, 45415
        • Dayton Physician LLC - Englewood
      • Dayton, Ohio, Verenigde Staten, 45409
        • Premier Blood and Cancer Center
      • Franklin, Ohio, Verenigde Staten, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, Verenigde Staten, 45331
        • Miami Valley Cancer Care and Infusion
      • Troy, Ohio, Verenigde Staten, 45373
        • Upper Valley Medical Center
      • Troy, Ohio, Verenigde Staten, 45373
        • Dayton Physicians LLC - Troy
    • Oklahoma
      • Lawton, Oklahoma, Verenigde Staten, 73505
        • Cancer Centers of Southwest Oklahoma Research
      • Oklahoma City, Oklahoma, Verenigde Staten, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Clackamas, Oregon, Verenigde Staten, 97015
        • Clackamas Radiation Oncology Center
      • Portland, Oregon, Verenigde Staten, 97239
        • Oregon Health and Science University
      • Portland, Oregon, Verenigde Staten, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Verenigde Staten, 97225
        • Providence Saint Vincent Medical Center
    • Pennsylvania
      • Erie, Pennsylvania, Verenigde Staten, 16505
        • UPMC Hillman Cancer Center Erie
      • Farrell, Pennsylvania, Verenigde Staten, 16121
        • UPMC Cancer Center at UPMC Horizon
      • Greensburg, Pennsylvania, Verenigde Staten, 15601
        • UPMC Cancer Centers - Arnold Palmer Pavilion
      • Greenville, Pennsylvania, Verenigde Staten, 16125
        • UPMC Hillman Cancer Center in Greenville/UPMC Horizon
      • Monroeville, Pennsylvania, Verenigde Staten, 15146
        • UPMC Hillman Cancer Center - Monroeville
      • Monroeville, Pennsylvania, Verenigde Staten, 15146
        • UPMC Cancer Center - Monroeville
      • New Castle, Pennsylvania, Verenigde Staten, 16105
        • UPMC Hillman Cancer Center - New Castle
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15232
        • UPMC Hillman Cancer Center
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15232
        • UPMC-Shadyside Hospital
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15215
        • UPMC-Saint Margaret
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15237
        • UPMC-Passavant Hospital
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15243
        • UPMC-Saint Clair Hospital Cancer Center
      • Seneca, Pennsylvania, Verenigde Staten, 16346
        • UPMC Cancer Center at UPMC Northwest
      • Washington, Pennsylvania, Verenigde Staten, 15301
        • UPMC Washington Hospital Radiation Oncology
      • Washington, Pennsylvania, Verenigde Staten, 15301
        • UPMC Cancer Center-Washington
    • Tennessee
      • Collierville, Tennessee, Verenigde Staten, 38017
        • Baptist Memorial Hospital and Cancer Center-Collierville
      • Memphis, Tennessee, Verenigde Staten, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
    • Texas
      • Dallas, Texas, Verenigde Staten, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, Verenigde Staten, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas, Texas, Verenigde Staten, 75237
        • UT Southwestern Simmons Cancer Center - RedBird
      • Fort Worth, Texas, Verenigde Staten, 76104
        • UT Southwestern/Simmons Cancer Center-Fort Worth
      • Richardson, Texas, Verenigde Staten, 75080
        • UT Southwestern Clinical Center at Richardson/Plano
      • San Antonio, Texas, Verenigde Staten, 78229
        • University of Texas Health Science Center at San Antonio
    • Washington
      • Seattle, Washington, Verenigde Staten, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Verenigde Staten, 98122
        • Swedish Medical Center-First Hill
      • Seattle, Washington, Verenigde Staten, 98122-5711
        • Swedish Medical Center-Cherry Hill
    • Wisconsin
      • Appleton, Wisconsin, Verenigde Staten, 54915
        • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
      • Brookfield, Wisconsin, Verenigde Staten, 53045
        • Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
      • Chilton, Wisconsin, Verenigde Staten, 53014
        • Ascension Calumet Hospital-Chilton
      • Eau Claire, Wisconsin, Verenigde Staten, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Franklin, Wisconsin, Verenigde Staten, 53132
        • Ascension Southeast Wisconsin Hospital - Franklin
      • Franklin, Wisconsin, Verenigde Staten, 53132
        • Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson
      • Marshfield, Wisconsin, Verenigde Staten, 54449
        • Marshfield Medical Center-Marshfield
      • Mequon, Wisconsin, Verenigde Staten, 53097
        • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
      • Milwaukee, Wisconsin, Verenigde Staten, 53210
        • Ascension Southeast Wisconsin Hospital-Saint Joseph-Milwaukee
      • Milwaukee, Wisconsin, Verenigde Staten, 53211
        • Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
      • Milwaukee, Wisconsin, Verenigde Staten, 53215
        • Ascension Saint Francis Hospital-Milwaukee
      • Minocqua, Wisconsin, Verenigde Staten, 54548
        • Marshfield Medical Center - Minocqua
      • New Richmond, Wisconsin, Verenigde Staten, 54017
        • Cancer Center of Western Wisconsin
      • Oshkosh, Wisconsin, Verenigde Staten, 54904
        • Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh
      • Racine, Wisconsin, Verenigde Staten, 53405
        • Ascension All Saints Hospital-Spring Street-Racine
      • Rice Lake, Wisconsin, Verenigde Staten, 54868
        • Marshfield Medical Center-Rice Lake
      • Stevens Point, Wisconsin, Verenigde Staten, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Wauwatosa, Wisconsin, Verenigde Staten, 53226
        • Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa
      • Weston, Wisconsin, Verenigde Staten, 54476
        • Marshfield Medical Center - Weston

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • REGISTRATION STEP 1: Participants must have pathologic (cytological or histological) proof of non-small cell lung cancer (NSCLC)
  • 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
  • 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
  • REGISTRATION STEP 1: Participants must not be candidates for concurrent chemoradiation in the opinion of the treating investigator
  • 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)
  • REGISTRATION STEP 1: Participants must have an MRI or CT scan of the brain with contrast within 28 days prior to Registration Step 1
  • REGISTRATION STEP 1: Participants' disease must fit within the radiation constraints in the opinion of a local radiation oncologist
  • 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
  • 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
  • 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
  • REGISTRATION STEP 1: Absolute neutrophil count (ANC) >= 1500/mcl (obtained within 28 days prior to Registration Step 1)
  • REGISTRATION STEP 1: Platelet count >= 100,000/mcl (obtained within 28 days prior to Registration Step 1)
  • REGISTRATION STEP 1: Hemoglobin >= 9 grams/dL (obtained within 28 days prior to Registration Step 1)
  • REGISTRATION STEP 1: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to Registration Step 1)
  • REGISTRATION STEP 1: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x IULN (obtained within 28 days prior to Registration Step 1)
  • 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)
  • 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
  • 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
  • REGISTRATION STEP 1: Participants must not have active autoimmune disease requiring therapy within the past 6 months
  • REGISTRATION STEP 1: Participants must not have an active infection requiring therapy
  • REGISTRATION STEP 1: Participants must be ≥ 18 years old
  • 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
  • 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
  • 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
  • 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
  • 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
  • REGISTRATION STEP 1: Participants must be offered optional participation in banking of specimens for future research
  • 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
  • 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
  • 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
  • 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
  • REGISTRATION STEP 2: Any toxicities from radiation therapy must have resolved to < grade 2
  • REGISTRATION STEP 2: ANC >= 1.5 x 10^3/uL (obtained within 28 days prior to Registration Step 2)
  • REGISTRATION STEP 2: Platelet count >= 100 x 10^3/uL (obtained within 28 days prior to Registration Step 2)
  • REGISTRATION STEP 2: Hemoglobin >= 9 grams/dL (obtained within 28 days prior to Registration Step 2)
  • REGISTRATION STEP 2: Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to Registration Step 2)
  • REGISTRATION STEP 2: AST and ALT =< 2.5 x IULN (obtained within 28 days prior to Registration Step 2)
  • 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)
  • 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
  • REGISTRATION STEP 2: Participants must not have received a live vaccine within 28 days prior to Registration Step 2

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Treatment (hypofractionated radiation therapy, atezolizumab)

RADIATION THERAPY: Patients undergo hypofractionated radiation therapy 5 days per week over 3 weeks for 15 fractions in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 12 months (maximum of 17 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and may undergo MRI throughout the study, as well as blood sample collection on study.
Procedure: Biospecimen Collection

Undergo blood sample collection

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Procedure: Computed Tomography

Undergo CT scan

Andere namen:
  • CT
  • KAT
  • CT-scan
  • Axiale computertomografie
  • Computergestuurde axiale tomografie
  • Computergestuurde tomografie
  • tomografie
  • Geautomatiseerde axiale tomografie (procedure)
  • Computertomografie (CT)-scan
  • Diagnostische kattencan
  • Diagnostisch CAT -scanservice type
Geneesmiddel: Atezolizumab

Given IV

Andere namen:
  • Tecentriq
  • MPDL3280A
  • RO5541267
  • RG7446
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL328OA
  • RG-7446
  • RG 7446
  • RO-5541267
Straling: Hypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

Andere namen:
  • Gehypofractioneerde radiotherapie
  • hypofractionering
  • Straling, gehypofractioneerd
  • Gehypofractioneerd

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of grade 3-5 adverse events
Tijdsspanne: From baseline, until 180 days from Step 2 registration

Individual toxicities with possible, probable or likely attribution to treatment along with the overall rate of grade 3, 4 or 5 toxicities attributable to treatment will be summarized.
From baseline, until 180 days from Step 2 registration

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of adverse events
Tijdsspanne: Up to 3 years

Individual toxicities with possible, probable or likely attribution to treatment along with the overall rate of grade 3, 4 or 5 toxicities attributable to treatment will be summarized.
Up to 3 years
Response rate (confirmed and unconfirmed, complete and partial by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) in the subset of patients with measurable disease (Registration Step 2)
Tijdsspanne: After atezolizumab treatment

Binary endpoints will be summarized as proportions with 95% Clopper-Pearson confidence intervals.
After atezolizumab treatment
Response rate (confirmed and unconfirmed, complete and partial by RECIST 1.1) in the subset of patients with measurable disease (Registration Step 1)
Tijdsspanne: During radiation therapy

Binary endpoints will be summarized as proportions with 95% Clopper-Pearson confidence intervals.
During radiation therapy
Progression-free survival
Tijdsspanne: From date of Step 2 registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years

Estimated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley.
From date of Step 2 registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Overall survival
Tijdsspanne: From date of Step 2 registration to date of death due to any cause, assessed up to 3 years

Estimated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley.
From date of Step 2 registration to date of death due to any cause, assessed up to 3 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Raid Aljumaily, SWOG Cancer Research Network

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 januari 2021

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 juni 2027

Studieregistratiedata

Eerst ingediend

16 maart 2020

Eerst ingediend dat voldeed aan de QC-criteria

16 maart 2020

Eerst geplaatst (Werkelijk)

17 maart 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

10 november 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NCI-2020-01543
  • U10CA180888 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2020-01543 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • S1933 (Andere identificatie: CTEP)
  • S1933 (Andere identificatie: SWOG)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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