Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT06192004
Status:
TERMINATED
Last Update Posted:
2025-06-03
First Post:
2023-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Non-Small Cell Lung Cancer Patients in the US Receiving Standard-of-Care and Initiating an Approved Therapy With Risk of Pneumonitis/ILD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung 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'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Observed event rate was below the rate required to meet study objectives.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-12-20', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity, Specificity, positive predictive value (PPV), negative predictive value (NPV) and odds ratio (OR) of the algorithm', 'timeFrame': 'Approximately 6 months', 'description': 'To complement the development of the algorithm to identify a patient at risk of pneumonitis/ILD.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity, specificity, PPV, NPV and OR of the algorithm', 'timeFrame': 'Approximately 6 months', 'description': 'To assess algorithm performance in identifying Pneumonitis/ILD and other lung/respiratory/thoracic-related events including but not limited to: tumor progression, pneumonia, COVID-19.'}, {'measure': 'Incidence of pneumonitis/ILD per grade', 'timeFrame': 'Approximately 6 months', 'description': 'To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.'}, {'measure': 'Time from anti-tumor treatment initiation to suspicion of pneumonitis/ILD', 'timeFrame': 'Approximately 6 months', 'description': 'To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.'}, {'measure': 'Time from anti-tumor treatment initiation to pneumonitis-related anti-tumor treatment dose delay, dose reduction, and/or discontinuation', 'timeFrame': 'Approximately 6 months', 'description': 'To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.'}, {'measure': 'Time from pneumonitis-related treatment or diagnosis to anti-tumor treatment dose delay, dose reduction, and/or discontinuation', 'timeFrame': 'Approximately 6 months', 'description': 'To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.'}, {'measure': 'Time from pneumonitis-related anti-tumor treatment discontinuation to rechallenge', 'timeFrame': 'Approximately 6 months', 'description': 'To characterize the onset and evolution over time of pneumonitis/ILD in patient receiving SoC for NSCLC.'}, {'measure': 'Resources used for the monitoring, diagnosis, or management of pneumonitis/ILD', 'timeFrame': 'Approximately 6 months', 'description': 'The use of corticosteroids, test(s) requirements for diagnosis, hospitalization will be evaluated to characterize the onset and evolution over time of pneumonitis/ILD in patient.'}, {'measure': "Change from baseline in St George's Respiratory Questionnaire (SGRQ-I) health status score", 'timeFrame': 'Approximately 6 months', 'description': "St George's Respiratory Questionnaire for Idiopathic Pulmonary Fibrosis"}, {'measure': 'Change from baseline in 5 Level EuroQoL 5 Dimension Questionnaire (EQ-5D-5L) health status score', 'timeFrame': 'Approximately 6 months', 'description': '5 Level EuroQoL 5 Dimension Questionnaire'}, {'measure': 'Change from baseline in symptom severity score', 'timeFrame': 'Approximately 6 months', 'description': 'Daily symptom severity rating'}, {'measure': 'Compliance rate of patient-reported symptoms', 'timeFrame': 'Approximately 6 months', 'description': 'Daily symptom severity rating'}, {'measure': 'Compliance rate of patient collected pulse oximetry assessment', 'timeFrame': 'Approximately 6 months', 'description': 'Daily pulse oximetry reading'}, {'measure': 'Incidence of pneumonitis/ILD and other lung/respiratory/thoracic-related events', 'timeFrame': 'Approximately 6 months', 'description': 'The incidence of pneumonitis/ILD and other lung/respiratory/thoracic-related events including but not limited to tumor progression, pneumonia, COVID-19, and associations and correlations with patient-generated data on eCOA will be assessed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Standard-of-Care', 'pneumonitis', 'Interstitial lung disease (ILD)'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is an observational, prospective, multicenter study conducted in the US to gather evidence in the context of lung cancer to complement the development of a digital solution.\n\nPatients initiating treatment for non-small cell lung cancer (NSCLC) will be prospectively followed to characterize risk factors, signs, and symptoms leading to onset, diagnosis, and treatment of pneumonitis/ILD should it occur.', 'detailedDescription': 'This is an observational, prospective, multicenter study conducted in the US to gather evidence in the context of lung cancer to complement the development of a digital solution.\n\nData will be collected prospectively from study sites using eCRFs and remotely from patients using a digital health tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD; receiving SoC and initiating treatment with an FDA-approved immune checkpoint inhibitor (alone or in combination with other agents), antibody drug conjugate, or small molecule EGFR inhibitor.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient must be 18 years of age or older, at the time of signing the ICF (Informed consent).\n2. Have histologically or cytologically documented unresectable Stage III or Stage IV NSCLC.\n3. Are initiating treatment with an FDA (Food and Drug Administration)-approved immune checkpoint inhibitor (alone or in combination with other agents), antibody drug conjugate, or small molecule EGFR inhibitor.\n4. Minimum life expectancy of 12 weeks at the time of signing the ICF.\n5. Able and willing to provide written signed informed consent.\n6. Able and willing to use the digital health tool throughout the duration of the study.\n\nExclusion Criteria:\n\n1. Concurrent participation in a research study or a clinical trial.\n2. Unable to receive SoC for the treatment and management of NSCLC including clinical or imaging assessments for up to 6 months.\n3. Judgment by the Investigator that the patient is unsuitable to participate in the study and/or the patient is unlikely to comply with study procedures and requirements.\n4. Confirmed or suspected diagnosis of pneumonitis/ILD at the time of signing ICF. This does not apply to historical pneumonitis/ILD events that have resolved prior to signing ICF.\n5. More than 2 weeks have passed from the administration of the first dose of qualifying FDA-approved treatment.'}, 'identificationModule': {'nctId': 'NCT06192004', 'acronym': 'LOOP', 'briefTitle': 'Study of Non-Small Cell Lung Cancer Patients in the US Receiving Standard-of-Care and Initiating an Approved Therapy With Risk of Pneumonitis/ILD', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Observational, Prospective, Multicenter Study of Non-Small Cell Lung Cancer Patients in the US Receiving Standard-of-Care and Initiating an Approved Therapy With Risk of Pneumonitis/ILD', 'orgStudyIdInfo': {'id': 'D7680C00001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective Cohort', 'description': 'NSCLC patients initiating an approved treatment with risk of pneumonitis/ILD.', 'interventionNames': ['Other: None (Observational Study)']}], 'interventions': [{'name': 'None (Observational Study)', 'type': 'OTHER', 'otherNames': ['Observational Study'], 'description': 'Not applicable since Observational Study', 'armGroupLabels': ['Prospective Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80222', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '50010-3014', 'city': 'Ames', 'state': 'Iowa', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.03471, 'lon': -93.61994}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '07932', 'city': 'Florham Park', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.78788, 'lon': -74.38821}}, {'zip': '08056', 'city': 'Mickleton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.79011, 'lon': -75.23768}}, {'zip': '11967', 'city': 'Shirley', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.80149, 'lon': -72.8676}}, {'zip': '11590', 'city': 'Westbury', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.75566, 'lon': -73.58763}}, {'zip': '44708', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44710', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44646', 'city': 'Massillon', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.79672, 'lon': -81.52151}}, {'zip': '17403', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}, {'zip': '78745', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77024', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75601', 'city': 'Longview', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.5007, 'lon': -94.74049}}, {'zip': '79902', 'city': 'Odessa', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.84568, 'lon': -102.36764}}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.\n\n"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}