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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04310020
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Hypofractionated Radiation Therapy — RADIATION
    Undergo hypofractionated radiation therapy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI

Study Details

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.

Key Dates

Start date
Jan 13, 2021
Status verified
Feb 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
47 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Rate of grade 3-5 adverse events [ Time Frame: From baseline, until 180 days from Step 2 registration ]

Locations (171)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham Cancer CenterBirminghamAlabama35233-
Alaska Breast Care and Surgery LLCAnchorageAlaska99508-
Alaska Oncology and Hematology LLCAnchorageAlaska99508-
Alaska Women's Cancer CareAnchorageAlaska99508-
Anchorage Associates in Radiation MedicineAnchorageAlaska98508-
Katmai Oncology GroupAnchorageAlaska99508-
Providence Alaska Medical CenterAnchorageAlaska99508-
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - JonesboroJonesboroArkansas72401-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
AdventHealth PorterDenverColorado80210-
AdventHealth LittletonLittletonColorado80122-
AdventHealth ParkerParkerColorado80138-
Mount Sinai Comprehensive Cancer Center at AventuraAventuraFlorida33180-
Mount Sinai Medical CenterMiami BeachFlorida33140-
Augusta University Medical CenterAugustaGeorgia30912-
CTCA at Southeastern Regional Medical CenterNewnanGeorgia30265-
Hawaii Cancer Care - Westridge‘AieaHawaii96701-
Pali Momi Medical Center‘AieaHawaii96701-
Queen's Cancer Center - Pearlridge‘AieaHawaii96701-
The Cancer Center of Hawaii-Pali Momi‘AieaHawaii96701-
Hawaii Cancer Care Inc - Waterfront PlazaHonoluluHawaii96813-
Hawaii Cancer Care Inc-LilihaHonoluluHawaii96817-
Island UrologyHonoluluHawaii96813-
Kapiolani Medical Center for Women and ChildrenHonoluluHawaii96826-
Queen's Cancer Cenrer - POB IHonoluluHawaii96813-
Queen's Cancer Center - KuakiniHonoluluHawaii96817-
Queen's Medical CenterHonoluluHawaii96813-
Straub Clinic and HospitalHonoluluHawaii96813-
The Cancer Center of Hawaii-LilihaHonoluluHawaii96817-
University of Hawaii Cancer CenterHonoluluHawaii96813-
Wilcox Memorial Hospital and Kauai Medical ClinicLihueHawaii96766-
Saint Alphonsus Cancer Care Center-NampaNampaIdaho83687-
Illinois CancerCare-BloomingtonBloomingtonIllinois61704-
Illinois CancerCare-CantonCantonIllinois61520-
Illinois CancerCare-CarthageCarthageIllinois62321-
Centralia Oncology ClinicCentraliaIllinois62801-
Saint Mary's HospitalCentraliaIllinois62801-
Jesse Brown Veterans Affairs Medical CenterChicagoIllinois60612-
University of IllinoisChicagoIllinois60612-
Carle at The RiverfrontDanvilleIllinois61832-
Cancer Care Specialists of Illinois - DecaturDecaturIllinois62526-
Decatur Memorial HospitalDecaturIllinois62526-
Carle Physician Group-EffinghamEffinghamIllinois62401-
Crossroads Cancer CenterEffinghamIllinois62401-
Illinois CancerCare-EurekaEurekaIllinois61530-
Illinois CancerCare-GalesburgGalesburgIllinois61401-
Illinois CancerCare-Kewanee ClinicKewaneeIllinois61443-
Illinois CancerCare-MacombMacombIllinois61455-
Carle Physician Group-Mattoon/CharlestonMattoonIllinois61938-
Cancer Care Center of O'FallonO'FallonIllinois62269-
HSHS Saint Elizabeth's HospitalO'FallonIllinois62269-
Illinois CancerCare-Ottawa ClinicOttawaIllinois61350-
Illinois CancerCare-PekinPekinIllinois61554-
Illinois CancerCare-PeoriaPeoriaIllinois61615-
Methodist Medical Center of IllinoisPeoriaIllinois61636-
Illinois CancerCare-PeruPeruIllinois61354-
Illinois CancerCare-PrincetonPrincetonIllinois61356-
Southern Illinois University School of MedicineSpringfieldIllinois62702-
Springfield ClinicSpringfieldIllinois62702-
Springfield Memorial HospitalSpringfieldIllinois62781-
Carle Cancer CenterUrbanaIllinois61801-
The Carle Foundation HospitalUrbanaIllinois61801-
Illinois CancerCare - WashingtonWashingtonIllinois61571-
Mary Greeley Medical CenterAmesIowa50010-
McFarland Clinic - AmesAmesIowa50010-
UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkenyIowa50023-
Mercy Cancer Center-West LakesCliveIowa50325-
UI Health Care Mission Cancer and Blood - West Des Moines ClinicCliveIowa50325-
Greater Regional Medical CenterCrestonIowa50801-
Broadlawns Medical CenterDes MoinesIowa50314-
Iowa Lutheran HospitalDes MoinesIowa50316-
Iowa Methodist Medical CenterDes MoinesIowa50309-
Mercy Medical Center - Des MoinesDes MoinesIowa50314-
UI Health Care Mission Cancer and Blood - Des Moines ClinicDes MoinesIowa50309-
UI Health Care Mission Cancer and Blood - Laurel ClinicDes MoinesIowa50314-
UI Health Care Mission Cancer and Blood - Waukee ClinicWaukeeIowa50263-
Mercy Medical Center-West LakesWest Des MoinesIowa50266-
Methodist West HospitalWest Des MoinesIowa50266-7700-
Saint Joseph HospitalLexingtonKentucky40504-
Saint Joseph Hospital EastLexingtonKentucky40509-
Saint Joseph Radiation Oncology Resource CenterLexingtonKentucky40504-
Beverly HospitalBeverlyMassachusetts01915-
Lahey Hospital and Medical CenterBurlingtonMassachusetts01805-
Addison Gilbert HospitalGloucesterMassachusetts01930-
Lahey Medical Center-PeabodyPeabodyMassachusetts01960-
Beth Israel Deaconess Medical Center/Winchester Center for Cancer CareWinchesterMassachusetts01890-
Henry Ford Health Providence Novi HospitalNoviMichigan48374-
Henry Ford Health Providence Southfield HospitalSouthfieldMichigan48075-
Fairview Southdale HospitalEdinaMinnesota55435-
Health Partners IncMinneapolisMinnesota55454-
Hennepin County Medical CenterMinneapolisMinnesota55415-
Regions HospitalSaint PaulMinnesota55101-
Lakeview HospitalStillwaterMinnesota55082-
Baptist Memorial Hospital and Cancer Center-DesotoSouthhavenMississippi38671-
Saint Francis Medical CenterCape GirardeauMissouri63703-
Parkland Health Center - FarmingtonFarmingtonMissouri63640-
Mercy Clinic-Rolla-Cancer and HematologyRollaMissouri65401-
Phelps Health Delbert Day Cancer InstituteRollaMissouri65401-
Sainte Genevieve County Memorial HospitalSainte GenevieveMissouri63670-
Mercy Hospital SpringfieldSpringfieldMissouri65804-
Missouri Baptist Medical CenterSt LouisMissouri63131-
Missouri Baptist Sullivan HospitalSullivanMissouri63080-
BJC Outpatient Center at Sunset HillsSunset HillsMissouri63127-
Bozeman Health Deaconess HospitalBozemanMontana59715-
Benefis Sletten Cancer InstituteGreat FallsMontana59405-
Logan Health Medical CenterKalispellMontana59901-
University of New Mexico Cancer CenterAlbuquerqueNew Mexico87106-
Montefiore Medical Center - Moses CampusThe BronxNew York10467-
Montefiore Medical Center-Einstein CampusThe BronxNew York10461-
Montefiore Medical Center-Weiler HospitalThe BronxNew York10461-
Dayton Physicians LLC-Miami Valley SouthCentervilleOhio45459-
Miami Valley Hospital SouthCentervilleOhio45459-
Dayton Physician LLC - EnglewoodDaytonOhio45415-
Miami Valley HospitalDaytonOhio45409-
Miami Valley Hospital NorthDaytonOhio45415-
Premier Blood and Cancer CenterDaytonOhio45409-
Atrium Medical Center-Middletown Regional HospitalFranklinOhio45005-1066-
Miami Valley Cancer Care and InfusionGreenvilleOhio45331-
Dayton Physicians LLC - TroyTroyOhio45373-
Upper Valley Medical CenterTroyOhio45373-
Cancer Centers of Southwest Oklahoma ResearchLawtonOklahoma73505-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Clackamas Radiation Oncology CenterClackamasOregon97015-
Oregon Health and Science UniversityPortlandOregon97239-
Providence Portland Medical CenterPortlandOregon97213-
Providence Saint Vincent Medical CenterPortlandOregon97225-
UPMC Hillman Cancer Center ErieEriePennsylvania16505-
UPMC Cancer Center at UPMC HorizonFarrellPennsylvania16121-
UPMC Cancer Centers - Arnold Palmer PavilionGreensburgPennsylvania15601-
UPMC Hillman Cancer Center in Greenville/UPMC HorizonGreenvillePennsylvania16125-
UPMC Cancer Center - MonroevilleMonroevillePennsylvania15146-
UPMC Hillman Cancer Center - MonroevilleMonroevillePennsylvania15146-
UPMC Hillman Cancer Center - New CastleNew CastlePennsylvania16105-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
UPMC-Passavant HospitalPittsburghPennsylvania15237-
UPMC-Saint Clair Hospital Cancer CenterPittsburghPennsylvania15243-
UPMC-Saint MargaretPittsburghPennsylvania15215-
UPMC-Shadyside HospitalPittsburghPennsylvania15232-
UPMC Cancer Center at UPMC NorthwestSenecaPennsylvania16346-
UPMC Cancer Center-WashingtonWashingtonPennsylvania15301-
UPMC Washington Hospital Radiation OncologyWashingtonPennsylvania15301-
Baptist Memorial Hospital and Cancer Center-ColliervilleColliervilleTennessee38017-
Baptist Memorial Hospital and Cancer Center-MemphisMemphisTennessee38120-
Parkland Memorial HospitalDallasTexas75235-
UT Southwestern Simmons Cancer Center - RedBirdDallasTexas75237-
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390-
UT Southwestern/Simmons Cancer Center-Fort WorthFort WorthTexas76104-
UT Southwestern Clinical Center at Richardson/PlanoRichardsonTexas75080-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-
Swedish Medical Center-Ballard CampusSeattleWashington98107-
Swedish Medical Center-Cherry HillSeattleWashington98122-5711-
Swedish Medical Center-First HillSeattleWashington98122-
Ascension Saint Elizabeth HospitalAppletonWisconsin54915-
Ascension Southeast Wisconsin Hospital - Elmbrook CampusBrookfieldWisconsin53045-
Ascension Calumet HospitalChiltonWisconsin53014-
Marshfield Medical Center-EC Cancer CenterEau ClaireWisconsin54701-
Ascension Saint Francis - Reiman Cancer CenterFranklinWisconsin53132-
Ascension Southeast Wisconsin Hospital - FranklinFranklinWisconsin53132-
Marshfield Medical Center-MarshfieldMarshfieldWisconsin54449-
Ascension Columbia Saint Mary's Hospital OzaukeeMequonWisconsin53097-
Ascension Columbia Saint Mary's Hospital - MilwaukeeMilwaukeeWisconsin53211-
Ascension Saint Francis HospitalMilwaukeeWisconsin53215-
Ascension Southeast Wisconsin Hospital - Saint Joseph CampusMilwaukeeWisconsin53210-
Marshfield Medical Center - MinocquaMinocquaWisconsin54548-
Cancer Center of Western WisconsinNew RichmondWisconsin54017-
Ascension Mercy HospitalOshkoshWisconsin54904-
Ascension All Saints HospitalRacineWisconsin53405-
Marshfield Medical Center-Rice LakeRice LakeWisconsin54868-
Marshfield Medical Center-River Region at Stevens PointStevens PointWisconsin54482-
Ascension Medical Group Southeast Wisconsin - Mayfair RoadWauwatosaWisconsin53226-
Marshfield Medical Center - WestonWestonWisconsin54476-

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