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

Who is this study for? Patients with stage II or III non-small cell lung cancer
Status: Recruiting
Location: See all (172) locations...
Intervention Type: Procedure, Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
RECRUITING
Anchorage
Alaska Oncology and Hematology LLC
RECRUITING
Anchorage
Alaska Women's Cancer Care
RECRUITING
Anchorage
Anchorage Associates in Radiation Medicine
RECRUITING
Anchorage
Katmai Oncology Group
RECRUITING
Anchorage
Providence Alaska Medical Center
RECRUITING
Anchorage
Alabama
University of Alabama at Birmingham Cancer Center
ACTIVE_NOT_RECRUITING
Birmingham
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
RECRUITING
Jonesboro
California
University of California Davis Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Sacramento
Colorado
AdventHealth Porter
ACTIVE_NOT_RECRUITING
Denver
AdventHealth Littleton
ACTIVE_NOT_RECRUITING
Littleton
AdventHealth Parker
ACTIVE_NOT_RECRUITING
Parker
Florida
Mount Sinai Comprehensive Cancer Center at Aventura
RECRUITING
Aventura
Mount Sinai Medical Center
RECRUITING
Miami Beach
Georgia
Augusta University Medical Center
RECRUITING
Augusta
CTCA at Southeastern Regional Medical Center
RECRUITING
Newnan
Hawaii
Hawaii Cancer Care - Westridge
ACTIVE_NOT_RECRUITING
‘aiea
Pali Momi Medical Center
ACTIVE_NOT_RECRUITING
‘aiea
Queen's Cancer Center - Pearlridge
ACTIVE_NOT_RECRUITING
‘aiea
The Cancer Center of Hawaii-Pali Momi
ACTIVE_NOT_RECRUITING
‘aiea
Hawaii Cancer Care Inc - Waterfront Plaza
ACTIVE_NOT_RECRUITING
Honolulu
Hawaii Cancer Care Inc-Liliha
ACTIVE_NOT_RECRUITING
Honolulu
Island Urology
ACTIVE_NOT_RECRUITING
Honolulu
Kapiolani Medical Center for Women and Children
ACTIVE_NOT_RECRUITING
Honolulu
Queen's Cancer Cenrer - POB I
ACTIVE_NOT_RECRUITING
Honolulu
Queen's Cancer Center - Kuakini
ACTIVE_NOT_RECRUITING
Honolulu
Queen's Medical Center
ACTIVE_NOT_RECRUITING
Honolulu
Straub Clinic and Hospital
ACTIVE_NOT_RECRUITING
Honolulu
The Cancer Center of Hawaii-Liliha
ACTIVE_NOT_RECRUITING
Honolulu
University of Hawaii Cancer Center
ACTIVE_NOT_RECRUITING
Honolulu
Wilcox Memorial Hospital and Kauai Medical Clinic
ACTIVE_NOT_RECRUITING
Lihue
Iowa
Mary Greeley Medical Center
RECRUITING
Ames
McFarland Clinic - Ames
RECRUITING
Ames
UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITING
Ankeny
Mercy Cancer Center-West Lakes
RECRUITING
Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
RECRUITING
Clive
Greater Regional Medical Center
RECRUITING
Creston
Broadlawns Medical Center
RECRUITING
Des Moines
Iowa Lutheran Hospital
RECRUITING
Des Moines
Iowa Methodist Medical Center
RECRUITING
Des Moines
Mercy Medical Center - Des Moines
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Waukee Clinic
RECRUITING
Waukee
Mercy Medical Center-West Lakes
RECRUITING
West Des Moines
Methodist West Hospital
RECRUITING
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Nampa
SUSPENDED
Nampa
Illinois
Illinois CancerCare-Bloomington
RECRUITING
Bloomington
Illinois CancerCare-Canton
RECRUITING
Canton
Illinois CancerCare-Carthage
RECRUITING
Carthage
Centralia Oncology Clinic
RECRUITING
Centralia
Saint Mary's Hospital
SUSPENDED
Centralia
Jesse Brown Veterans Affairs Medical Center
SUSPENDED
Chicago
University of Illinois
RECRUITING
Chicago
Carle at The Riverfront
RECRUITING
Danville
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Carle Physician Group-Effingham
RECRUITING
Effingham
Crossroads Cancer Center
RECRUITING
Effingham
Illinois CancerCare-Eureka
RECRUITING
Eureka
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Illinois CancerCare-Kewanee Clinic
RECRUITING
Kewanee
Illinois CancerCare-Macomb
RECRUITING
Macomb
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
HSHS Saint Elizabeth's Hospital
RECRUITING
O'fallon
Illinois CancerCare-Ottawa Clinic
RECRUITING
Ottawa
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois CancerCare-Peoria
RECRUITING
Peoria
Methodist Medical Center of Illinois
RECRUITING
Peoria
Illinois CancerCare-Peru
RECRUITING
Peru
Illinois CancerCare-Princeton
RECRUITING
Princeton
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Springfield Memorial Hospital
RECRUITING
Springfield
Carle Cancer Center
RECRUITING
Urbana
The Carle Foundation Hospital
RECRUITING
Urbana
Illinois CancerCare - Washington
RECRUITING
Washington
Kentucky
Saint Joseph Hospital
ACTIVE_NOT_RECRUITING
Lexington
Saint Joseph Hospital East
ACTIVE_NOT_RECRUITING
Lexington
Saint Joseph Radiation Oncology Resource Center
ACTIVE_NOT_RECRUITING
Lexington
Massachusetts
Beverly Hospital
RECRUITING
Beverly
Lahey Hospital and Medical Center
RECRUITING
Burlington
Addison Gilbert Hospital
RECRUITING
Gloucester
Lahey Medical Center-Peabody
RECRUITING
Peabody
Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
ACTIVE_NOT_RECRUITING
Winchester
Michigan
Henry Ford Health Providence Novi Hospital
RECRUITING
Novi
Henry Ford Health Providence Southfield Hospital
RECRUITING
Southfield
Minnesota
Fairview Southdale Hospital
RECRUITING
Edina
Health Partners Inc
RECRUITING
Minneapolis
Hennepin County Medical Center
RECRUITING
Minneapolis
Regions Hospital
RECRUITING
Saint Paul
Lakeview Hospital
RECRUITING
Stillwater
Missouri
Saint Francis Medical Center
RECRUITING
Cape Girardeau
Parkland Health Center - Farmington
RECRUITING
Farmington
Mercy Clinic-Rolla-Cancer and Hematology
RECRUITING
Rolla
Phelps Health Delbert Day Cancer Institute
RECRUITING
Rolla
Sainte Genevieve County Memorial Hospital
RECRUITING
Sainte Genevieve
Mercy Hospital Springfield
RECRUITING
Springfield
Missouri Baptist Medical Center
RECRUITING
St Louis
Missouri Baptist Sullivan Hospital
RECRUITING
Sullivan
BJC Outpatient Center at Sunset Hills
RECRUITING
Sunset Hills
Mississippi
Baptist Memorial Hospital and Cancer Center-Desoto
RECRUITING
Southhaven
Montana
Bozeman Health Deaconess Hospital
RECRUITING
Bozeman
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
Logan Health Medical Center
RECRUITING
Kalispell
New Mexico
University of New Mexico Cancer Center
ACTIVE_NOT_RECRUITING
Albuquerque
New York
Montefiore Medical Center - Moses Campus
ACTIVE_NOT_RECRUITING
The Bronx
Montefiore Medical Center-Einstein Campus
ACTIVE_NOT_RECRUITING
The Bronx
Montefiore Medical Center-Weiler Hospital
ACTIVE_NOT_RECRUITING
The Bronx
Ohio
Dayton Physicians LLC-Miami Valley South
ACTIVE_NOT_RECRUITING
Centerville
Miami Valley Hospital South
RECRUITING
Centerville
Dayton Physician LLC - Englewood
ACTIVE_NOT_RECRUITING
Dayton
Miami Valley Hospital
RECRUITING
Dayton
Miami Valley Hospital North
RECRUITING
Dayton
Premier Blood and Cancer Center
RECRUITING
Dayton
Atrium Medical Center-Middletown Regional Hospital
RECRUITING
Franklin
Miami Valley Cancer Care and Infusion
RECRUITING
Greenville
Dayton Physicians LLC - Troy
ACTIVE_NOT_RECRUITING
Troy
Upper Valley Medical Center
RECRUITING
Troy
Oklahoma
Cancer Centers of Southwest Oklahoma Research
RECRUITING
Lawton
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Clackamas Radiation Oncology Center
RECRUITING
Clackamas
Oregon Health and Science University
ACTIVE_NOT_RECRUITING
Portland
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Pennsylvania
UPMC Hillman Cancer Center Erie
RECRUITING
Erie
UPMC Cancer Center at UPMC Horizon
RECRUITING
Farrell
UPMC Cancer Centers - Arnold Palmer Pavilion
RECRUITING
Greensburg
UPMC Hillman Cancer Center in Greenville/UPMC Horizon
RECRUITING
Greenville
UPMC Cancer Center - Monroeville
RECRUITING
Monroeville
UPMC Hillman Cancer Center - Monroeville
RECRUITING
Monroeville
UPMC Hillman Cancer Center - New Castle
RECRUITING
New Castle
Thomas Jefferson University Hospital
WITHDRAWN
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
RECRUITING
Pittsburgh
UPMC-Passavant Hospital
RECRUITING
Pittsburgh
UPMC-Saint Clair Hospital Cancer Center
RECRUITING
Pittsburgh
UPMC-Saint Margaret
RECRUITING
Pittsburgh
UPMC-Shadyside Hospital
RECRUITING
Pittsburgh
UPMC Cancer Center at UPMC Northwest
RECRUITING
Seneca
UPMC Cancer Center-Washington
RECRUITING
Washington
UPMC Washington Hospital Radiation Oncology
RECRUITING
Washington
Tennessee
Baptist Memorial Hospital and Cancer Center-Collierville
RECRUITING
Collierville
Baptist Memorial Hospital and Cancer Center-Memphis
RECRUITING
Memphis
Texas
Parkland Memorial Hospital
ACTIVE_NOT_RECRUITING
Dallas
UT Southwestern Simmons Cancer Center - RedBird
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
ACTIVE_NOT_RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
ACTIVE_NOT_RECRUITING
Fort Worth
UT Southwestern Clinical Center at Richardson/Plano
ACTIVE_NOT_RECRUITING
Richardson
University of Texas Health Science Center at San Antonio
ACTIVE_NOT_RECRUITING
San Antonio
Washington
Swedish Medical Center-Ballard Campus
RECRUITING
Seattle
Swedish Medical Center-Cherry Hill
RECRUITING
Seattle
Swedish Medical Center-First Hill
RECRUITING
Seattle
Wisconsin
Ascension Saint Elizabeth Hospital
RECRUITING
Appleton
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
RECRUITING
Brookfield
Ascension Calumet Hospital
RECRUITING
Chilton
Marshfield Medical Center-EC Cancer Center
RECRUITING
Eau Claire
Ascension Saint Francis - Reiman Cancer Center
RECRUITING
Franklin
Ascension Southeast Wisconsin Hospital - Franklin
RECRUITING
Franklin
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
Ascension Columbia Saint Mary's Hospital Ozaukee
RECRUITING
Mequon
Ascension Columbia Saint Mary's Hospital - Milwaukee
RECRUITING
Milwaukee
Ascension Saint Francis Hospital
RECRUITING
Milwaukee
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
RECRUITING
Milwaukee
Marshfield Medical Center - Minocqua
RECRUITING
Minocqua
Cancer Center of Western Wisconsin
RECRUITING
New Richmond
Ascension Mercy Hospital
RECRUITING
Oshkosh
Ascension All Saints Hospital
RECRUITING
Racine
Marshfield Medical Center-Rice Lake
RECRUITING
Rice Lake
Marshfield Medical Center-River Region at Stevens Point
RECRUITING
Stevens Point
Ascension Medical Group Southeast Wisconsin - Mayfair Road
RECRUITING
Wauwatosa
Marshfield Medical Center - Weston
RECRUITING
Weston
Time Frame
Start Date: 2021-01-13
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 47
Treatments
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.
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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