Non-Small Cell Lung Cancer (NSCLC) Clinical Trials

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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: Active_not_recruiting
Location: See all (171) 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
Anchorage
Alaska Oncology and Hematology LLC
Anchorage
Alaska Women's Cancer Care
Anchorage
Anchorage Associates in Radiation Medicine
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
Alabama
University of Alabama at Birmingham Cancer Center
Birmingham
Arkansas
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
California
University of California Davis Comprehensive Cancer Center
Sacramento
Colorado
AdventHealth Porter
Denver
AdventHealth Littleton
Littleton
AdventHealth Parker
Parker
Florida
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura
Mount Sinai Medical Center
Miami Beach
Georgia
Augusta University Medical Center
Augusta
CTCA at Southeastern Regional Medical Center
Newnan
Hawaii
Hawaii Cancer Care - Westridge
‘aiea
Pali Momi Medical Center
‘aiea
Queen's Cancer Center - Pearlridge
‘aiea
The Cancer Center of Hawaii-Pali Momi
‘aiea
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Hawaii Cancer Care Inc-Liliha
Honolulu
Island Urology
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Queen's Cancer Cenrer - POB I
Honolulu
Queen's Cancer Center - Kuakini
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
University of Hawaii Cancer Center
Honolulu
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue
Iowa
Mary Greeley Medical Center
Ames
McFarland Clinic - Ames
Ames
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny
Mercy Cancer Center-West Lakes
Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive
Greater Regional Medical Center
Creston
Broadlawns Medical Center
Des Moines
Iowa Lutheran Hospital
Des Moines
Iowa Methodist Medical Center
Des Moines
Mercy Medical Center - Des Moines
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee
Mercy Medical Center-West Lakes
West Des Moines
Methodist West Hospital
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Nampa
Nampa
Illinois
Illinois CancerCare-Bloomington
Bloomington
Illinois CancerCare-Canton
Canton
Illinois CancerCare-Carthage
Carthage
Centralia Oncology Clinic
Centralia
Saint Mary's Hospital
Centralia
Jesse Brown Veterans Affairs Medical Center
Chicago
University of Illinois
Chicago
Carle at The Riverfront
Danville
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Carle Physician Group-Effingham
Effingham
Crossroads Cancer Center
Effingham
Illinois CancerCare-Eureka
Eureka
Illinois CancerCare-Galesburg
Galesburg
Illinois CancerCare-Kewanee Clinic
Kewanee
Illinois CancerCare-Macomb
Macomb
Carle Physician Group-Mattoon/Charleston
Mattoon
Cancer Care Center of O'Fallon
O'fallon
HSHS Saint Elizabeth's Hospital
O'fallon
Illinois CancerCare-Ottawa Clinic
Ottawa
Illinois CancerCare-Pekin
Pekin
Illinois CancerCare-Peoria
Peoria
Methodist Medical Center of Illinois
Peoria
Illinois CancerCare-Peru
Peru
Illinois CancerCare-Princeton
Princeton
Southern Illinois University School of Medicine
Springfield
Springfield Clinic
Springfield
Springfield Memorial Hospital
Springfield
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Illinois CancerCare - Washington
Washington
Kentucky
Saint Joseph Hospital
Lexington
Saint Joseph Hospital East
Lexington
Saint Joseph Radiation Oncology Resource Center
Lexington
Massachusetts
Beverly Hospital
Beverly
Lahey Hospital and Medical Center
Burlington
Addison Gilbert Hospital
Gloucester
Lahey Medical Center-Peabody
Peabody
Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
Winchester
Michigan
Henry Ford Health Providence Novi Hospital
Novi
Henry Ford Health Providence Southfield Hospital
Southfield
Minnesota
Fairview Southdale Hospital
Edina
Health Partners Inc
Minneapolis
Hennepin County Medical Center
Minneapolis
Regions Hospital
Saint Paul
Lakeview Hospital
Stillwater
Missouri
Saint Francis Medical Center
Cape Girardeau
Parkland Health Center - Farmington
Farmington
Mercy Clinic-Rolla-Cancer and Hematology
Rolla
Phelps Health Delbert Day Cancer Institute
Rolla
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
Mercy Hospital Springfield
Springfield
Missouri Baptist Medical Center
St Louis
Missouri Baptist Sullivan Hospital
Sullivan
BJC Outpatient Center at Sunset Hills
Sunset Hills
Mississippi
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven
Montana
Bozeman Health Deaconess Hospital
Bozeman
Benefis Sletten Cancer Institute
Great Falls
Logan Health Medical Center
Kalispell
New Mexico
University of New Mexico Cancer Center
Albuquerque
New York
Montefiore Medical Center - Moses Campus
The Bronx
Montefiore Medical Center-Einstein Campus
The Bronx
Montefiore Medical Center-Weiler Hospital
The Bronx
Ohio
Dayton Physicians LLC-Miami Valley South
Centerville
Miami Valley Hospital South
Centerville
Dayton Physician LLC - Englewood
Dayton
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Premier Blood and Cancer Center
Dayton
Atrium Medical Center-Middletown Regional Hospital
Franklin
Miami Valley Cancer Care and Infusion
Greenville
Dayton Physicians LLC - Troy
Troy
Upper Valley Medical Center
Troy
Oklahoma
Cancer Centers of Southwest Oklahoma Research
Lawton
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Clackamas Radiation Oncology Center
Clackamas
Oregon Health and Science University
Portland
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Pennsylvania
UPMC Hillman Cancer Center Erie
Erie
UPMC Cancer Center at UPMC Horizon
Farrell
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg
UPMC Hillman Cancer Center in Greenville/UPMC Horizon
Greenville
UPMC Cancer Center - Monroeville
Monroeville
UPMC Hillman Cancer Center - Monroeville
Monroeville
UPMC Hillman Cancer Center - New Castle
New Castle
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh
UPMC-Passavant Hospital
Pittsburgh
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh
UPMC-Saint Margaret
Pittsburgh
UPMC-Shadyside Hospital
Pittsburgh
UPMC Cancer Center at UPMC Northwest
Seneca
UPMC Cancer Center-Washington
Washington
UPMC Washington Hospital Radiation Oncology
Washington
Tennessee
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis
Texas
Parkland Memorial Hospital
Dallas
UT Southwestern Simmons Cancer Center - RedBird
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth
UT Southwestern Clinical Center at Richardson/Plano
Richardson
University of Texas Health Science Center at San Antonio
San Antonio
Washington
Swedish Medical Center-Ballard Campus
Seattle
Swedish Medical Center-Cherry Hill
Seattle
Swedish Medical Center-First Hill
Seattle
Wisconsin
Ascension Saint Elizabeth Hospital
Appleton
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
Brookfield
Ascension Calumet Hospital
Chilton
Marshfield Medical Center-EC Cancer Center
Eau Claire
Ascension Saint Francis - Reiman Cancer Center
Franklin
Ascension Southeast Wisconsin Hospital - Franklin
Franklin
Marshfield Medical Center-Marshfield
Marshfield
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee
Ascension Saint Francis Hospital
Milwaukee
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Milwaukee
Marshfield Medical Center - Minocqua
Minocqua
Cancer Center of Western Wisconsin
New Richmond
Ascension Mercy Hospital
Oshkosh
Ascension All Saints Hospital
Racine
Marshfield Medical Center-Rice Lake
Rice Lake
Marshfield Medical Center-River Region at Stevens Point
Stevens Point
Ascension Medical Group Southeast Wisconsin - Mayfair Road
Wauwatosa
Marshfield Medical Center - Weston
Weston
Time Frame
Start Date: 2021-01-13
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