Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT04310020
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2020-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Radiation Therapy Followed by Atezolizumab in Stage II or III Non-small Cell Lung Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D000069473', 'term': 'Radiation Dose Hypofractionation'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D019583', 'term': 'Dose Fractionation, Radiation'}, {'id': 'D011879', 'term': 'Radiotherapy Dosage'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 47}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-03-16', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of grade 3-5 adverse events', 'timeFrame': 'From baseline, until 180 days from Step 2 registration', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 3 years', 'description': '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.'}, {'measure': '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)', 'timeFrame': 'After atezolizumab treatment', 'description': 'Binary endpoints will be summarized as proportions with 95% Clopper-Pearson confidence intervals.'}, {'measure': 'Response rate (confirmed and unconfirmed, complete and partial by RECIST 1.1) in the subset of patients with measurable disease (Registration Step 1)', 'timeFrame': 'During radiation therapy', 'description': 'Binary endpoints will be summarized as proportions with 95% Clopper-Pearson confidence intervals.'}, {'measure': 'Progression-free survival', 'timeFrame': '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', 'description': 'Estimated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley.'}, {'measure': 'Overall survival', 'timeFrame': 'From date of Step 2 registration to date of death due to any cause, assessed up to 3 years', 'description': 'Estimated using the method of Kaplan-Meier. 95% confidence for the medians will be constructed using the method of Brookmeyer-Crowley.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Non-Small Cell Carcinoma', 'Stage II Lung Cancer AJCC v8', 'Stage III Lung Cancer AJCC v8']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. 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.\n\nSECONDARY OBJECTIVES:\n\nI. 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.\n\nII. 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.\n\nIII. To evaluate progression free survival (PFS) from Registration Step 2 by RECIST 1.1.\n\nIV. To evaluate overall survival (OS) from Registration Step 2. V. To evaluate the frequency and severity of toxicities.\n\nADDITIONAL OBJECTIVE:\n\nI. To bank blood and archival tissue for future research.\n\nOUTLINE:\n\nRADIATION 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.\n\nCONSOLIDATION: 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.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* REGISTRATION STEP 1: Participants must have pathologic (cytological or histological) proof of non-small cell lung cancer (NSCLC)\n* 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\n* 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\n* REGISTRATION STEP 1: Participants must not be candidates for concurrent chemoradiation in the opinion of the treating investigator\n* 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)\n* REGISTRATION STEP 1: Participants must have an MRI or CT scan of the brain with contrast within 28 days prior to Registration Step 1\n* REGISTRATION STEP 1: Participants\' disease must fit within the radiation constraints in the opinion of a local radiation oncologist\n* 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\n* 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\n* 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\n* REGISTRATION STEP 1: Absolute neutrophil count (ANC) \\>= 1500/mcl (obtained within 28 days prior to Registration Step 1)\n* REGISTRATION STEP 1: Platelet count \\>= 100,000/mcl (obtained within 28 days prior to Registration Step 1)\n* REGISTRATION STEP 1: Hemoglobin \\>= 9 grams/dL (obtained within 28 days prior to Registration Step 1)\n* REGISTRATION STEP 1: Total bilirubin =\\< 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to Registration Step 1)\n* REGISTRATION STEP 1: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\< 2.5 x IULN (obtained within 28 days prior to Registration Step 1)\n* 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)\n* 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\n* 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\n* REGISTRATION STEP 1: Participants must not have active autoimmune disease requiring therapy within the past 6 months\n* REGISTRATION STEP 1: Participants must not have an active infection requiring therapy\n* REGISTRATION STEP 1: Participants must be ≥ 18 years old\n* 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\n* 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\n* 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\n* 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\n* 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\n* REGISTRATION STEP 1: Participants must be offered optional participation in banking of specimens for future research\n* 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\n* 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\n* 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\n* 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\n* REGISTRATION STEP 2: Any toxicities from radiation therapy must have resolved to \\< grade 2\n* REGISTRATION STEP 2: ANC \\>= 1.5 x 10\\^3/uL (obtained within 28 days prior to Registration Step 2)\n* REGISTRATION STEP 2: Platelet count \\>= 100 x 10\\^3/uL (obtained within 28 days prior to Registration Step 2)\n* REGISTRATION STEP 2: Hemoglobin \\>= 9 grams/dL (obtained within 28 days prior to Registration Step 2)\n* REGISTRATION STEP 2: Total bilirubin =\\< 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to Registration Step 2)\n* REGISTRATION STEP 2: AST and ALT =\\< 2.5 x IULN (obtained within 28 days prior to Registration Step 2)\n* 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)\n* 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\n* REGISTRATION STEP 2: Participants must not have received a live vaccine within 28 days prior to Registration Step 2'}, 'identificationModule': {'nctId': 'NCT04310020', 'briefTitle': 'Study of Radiation Therapy Followed by Atezolizumab in Stage II or III Non-small Cell Lung Cancer Patients', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients With Borderline Performance Status', 'orgStudyIdInfo': {'id': 'NCI-2020-01543'}, 'secondaryIdInfos': [{'id': 'NCI-2020-01543', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'S1933', 'type': 'OTHER', 'domain': 'SWOG'}, {'id': 'S1933', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180888', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180888', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (hypofractionated radiation therapy, atezolizumab)', 'description': '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.\n\nCONSOLIDATION: 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.', 'interventionNames': ['Drug: Atezolizumab', 'Procedure: Biospecimen Collection', 'Procedure: Computed Tomography', 'Radiation: Hypofractionated Radiation Therapy', 'Procedure: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['MPDL 3280A', 'MPDL 328OA', 'MPDL-3280A', 'MPDL3280A', 'MPDL328OA', 'RG 7446', 'RG-7446', 'RG7446', 'RO 5541267', 'RO-5541267', 'RO5541267', 'Tecentriq'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (hypofractionated radiation therapy, atezolizumab)']}, {'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Treatment (hypofractionated radiation therapy, atezolizumab)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'Diagnostic CAT Scan', 'Diagnostic CAT Scan Service Type', 'tomography'], 'description': 'Undergo CT scan', 'armGroupLabels': ['Treatment (hypofractionated radiation therapy, atezolizumab)']}, {'name': 'Hypofractionated Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Hypofractionated', 'Hypofractionated Radiotherapy', 'hypofractionation', 'Radiation, Hypofractionated'], 'description': 'Undergo hypofractionated radiation therapy', 'armGroupLabels': ['Treatment (hypofractionated radiation therapy, atezolizumab)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging (MRI)', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'MRIs', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging', 'sMRI', 'Structural MRI'], 'description': 'Undergo MRI', 'armGroupLabels': ['Treatment (hypofractionated radiation therapy, atezolizumab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '98508', 'city': 'Anchorage', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'AKPAMC.OncologyResearchSupport@providence.org', 'phone': '907-212-6871'}, {'name': 'Charles W. Drescher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Anchorage Associates in Radiation Medicine', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'AKPAMC.OncologyResearchSupport@providence.org', 'phone': '907-212-6871'}, {'name': 'Charles W. Drescher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alaska Breast Care and Surgery LLC', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'AKPAMC.OncologyResearchSupport@providence.org', 'phone': '907-212-6871'}, {'name': 'Charles W. Drescher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alaska Oncology and Hematology LLC', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'AKPAMC.OncologyResearchSupport@providence.org', 'phone': '907-212-6871'}, {'name': 'Charles W. Drescher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Alaska Women's Cancer Care", 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'AKPAMC.OncologyResearchSupport@providence.org', 'phone': '907-212-6871'}, {'name': 'Charles W. Drescher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Katmai Oncology Group', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'AKPAMC.OncologyResearchSupport@providence.org', 'phone': '907-212-6871'}, {'name': 'Charles W. Drescher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Providence Alaska Medical Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'Emily.Carvell@bmhcc.org', 'phone': '870-936-7066'}, {'name': 'Sohail A. 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