Lung Cancer Clinical Trial
Study of Radiation Therapy Followed by Atezolizumab in Stage II or III Non-small Cell Lung Cancer Patients
Summary
This trial studies the side effects of radiation therapy followed by atezolizumab in treating patients with stage II or III non-small cell lung cancer. Hyperfractionated radiation therapy delivers smaller doses of radiation therapy over time and may kill more tumor 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.
Full Description
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 for 3 weeks in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 21 days for up to 12 months (maximum of 17 cycles) in the absence of disease progression or unacceptable toxicity.
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.
Eligibility Criteria
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 computed tomography (CT) or magnetic resonance imaging (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 50% 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 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: Absolute neutrophil count (ANC) >= 1500/mcl (obtained within 28 days prior to Registration Step 2)
REGISTRATION STEP 2: Platelet count >= 100,000/mcl (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
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There are 100 Locations for this study
Birmingham Alabama, 35233, United States More Info
Principal Investigator
Jonesboro Arkansas, 72401, United States More Info
Principal Investigator
Sacramento California, 95817, United States
Denver Colorado, 80210, United States More Info
Principal Investigator
Littleton Colorado, 80122, United States More Info
Principal Investigator
Parker Colorado, 80138, United States More Info
Principal Investigator
Aventura Florida, 33180, United States More Info
Principal Investigator
Miami Beach Florida, 33140, United States More Info
Principal Investigator
Augusta Georgia, 30912, United States More Info
Principal Investigator
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96826, United States
Lihue Hawaii, 96766, United States
Nampa Idaho, 83686, United States More Info
Principal Investigator
Bloomington Illinois, 61704, United States More Info
Principal Investigator
Canton Illinois, 61520, United States More Info
Principal Investigator
Carthage Illinois, 62321, United States More Info
Principal Investigator
Centralia Illinois, 62801, United States More Info
Principal Investigator
Chicago Illinois, 60612, United States More Info
Principal Investigator
Danville Illinois, 61832, United States More Info
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Decatur Illinois, 62526, United States More Info
Principal Investigator
Decatur Illinois, 62526, United States More Info
Principal Investigator
Effingham Illinois, 62401, United States More Info
Principal Investigator
Effingham Illinois, 62401, United States More Info
Principal Investigator
Eureka Illinois, 61530, United States More Info
Principal Investigator
Galesburg Illinois, 61401, United States More Info
Principal Investigator
Kewanee Illinois, 61443, United States More Info
Principal Investigator
Macomb Illinois, 61455, United States More Info
Principal Investigator
Mattoon Illinois, 61938, United States More Info
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O'Fallon Illinois, 62269, United States More Info
Principal Investigator
Ottawa Illinois, 61350, United States More Info
Principal Investigator
Pekin Illinois, 61554, United States More Info
Principal Investigator
Peoria Illinois, 61615, United States More Info
Principal Investigator
Peoria Illinois, 61636, United States More Info
Principal Investigator
Peru Illinois, 61354, United States More Info
Principal Investigator
Princeton Illinois, 61356, United States More Info
Principal Investigator
Springfield Illinois, 62702, United States More Info
Principal Investigator
Springfield Illinois, 62702, United States More Info
Principal Investigator
Springfield Illinois, 62781, United States More Info
Principal Investigator
Urbana Illinois, 61801, United States More Info
Principal Investigator
Urbana Illinois, 61801, United States More Info
Principal Investigator
Washington Illinois, 61571, United States More Info
Principal Investigator
Ames Iowa, 50010, United States More Info
Principal Investigator
Ames Iowa, 50010, United States More Info
Principal Investigator
Clive Iowa, 50325, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
West Des Moines Iowa, 50266, United States
Beverly Massachusetts, 01915, United States More Info
Principal Investigator
Burlington Massachusetts, 01805, United States More Info
Principal Investigator
Gloucester Massachusetts, 01930, United States More Info
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Peabody Massachusetts, 01960, United States More Info
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Winchester Massachusetts, 01890, United States More Info
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Southhaven Mississippi, 38671, United States More Info
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Cape Girardeau Missouri, 63703, United States More Info
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Farmington Missouri, 63640, United States More Info
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Rolla Missouri, 65401, United States More Info
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Rolla Missouri, 65401, United States More Info
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Saint Louis Missouri, 63131, United States More Info
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Sainte Genevieve Missouri, 63670, United States More Info
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Springfield Missouri, 65804, United States More Info
Principal Investigator
Sullivan Missouri, 63080, United States More Info
Principal Investigator
Sunset Hills Missouri, 63127, United States More Info
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Bozeman Montana, 59715, United States More Info
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Great Falls Montana, 59405, United States More Info
Principal Investigator
Kalispell Montana, 59901, United States More Info
Principal Investigator
Albuquerque New Mexico, 87102, United States More Info
Principal Investigator
Bronx New York, 10461, United States More Info
Principal Investigator
Bronx New York, 10461, United States More Info
Principal Investigator
Bronx New York, 10467, United States More Info
Principal Investigator
Centerville Ohio, 45459, United States More Info
Principal Investigator
Centerville Ohio, 45459, United States
Lawton Oklahoma, 73505, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Clackamas Oregon, 97015, United States More Info
Principal Investigator
Portland Oregon, 97213, United States More Info
Principal Investigator
Portland Oregon, 97239, United States
Erie Pennsylvania, 16505, United States More Info
Principal Investigator
Farrell Pennsylvania, 16121, United States More Info
Principal Investigator
Greensburg Pennsylvania, 15601, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15232, United States More Info
Principal Investigator
Pittsburgh Pennsylvania, 15232, United States More Info
Principal Investigator
Collierville Tennessee, 38017, United States More Info
Principal Investigator
Memphis Tennessee, 38120, United States More Info
Principal Investigator
Dallas Texas, 75235, United States More Info
Principal Investigator
Dallas Texas, 75390, United States More Info
Principal Investigator
Fort Worth Texas, 76104, United States More Info
Principal Investigator
Richardson Texas, 75080, United States More Info
Principal Investigator
San Antonio Texas, 78229, United States More Info
Principal Investigator
Appleton Wisconsin, 54915, United States More Info
Principal Investigator
Brookfield Wisconsin, 53045, United States More Info
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Chilton Wisconsin, 53014, United States More Info
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Eau Claire Wisconsin, 54701, United States More Info
Principal Investigator
Franklin Wisconsin, 53132, United States More Info
Principal Investigator
Franklin Wisconsin, 53132, United States More Info
Principal Investigator
Marshfield Wisconsin, 54449, United States More Info
Principal Investigator
Mequon Wisconsin, 53097, United States More Info
Principal Investigator
Milwaukee Wisconsin, 53210, United States More Info
Principal Investigator
Milwaukee Wisconsin, 53211, United States More Info
Principal Investigator
Milwaukee Wisconsin, 53215, United States More Info
Principal Investigator
Minocqua Wisconsin, 54548, United States More Info
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Oshkosh Wisconsin, 54904, United States More Info
Principal Investigator
Racine Wisconsin, 53405, United States More Info
Principal Investigator
Rice Lake Wisconsin, 54868, United States More Info
Principal Investigator
Stevens Point Wisconsin, 54482, United States More Info
Principal Investigator
Wauwatosa Wisconsin, 53226, United States More Info
Principal Investigator
Weston Wisconsin, 54476, United States More Info
Principal Investigator
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