Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-01-04 @ 3:17 PM
Study NCT ID:
NCT03877250
Status:
WITHDRAWN
Last Update Posted:
2025-05-15
First Post:
2019-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Biopsy Specimens to Study Responses to PD-1 or PD-L1 Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The primary objectives have not been met due to no patient enrollment therefore, the PI is requesting to close the study at this time.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2019-03-12', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants biopsied on-treatment and with newly diagnosed or recurrent PD-L1 advanced Non Small Cell Lung Cancer/NSCLC', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PD-L1 High', '19-030', 'Memorial Sloan Kettering Cancer Center'], 'conditions': ['Non Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to attempt to obtain an on-treatment biopsy in participants with non-small cell lung cancer who are receiving standard treatment with a drug that targets the PD-1 or PD-L1 protein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with newly diagnosed or recurrent, PD-L1 high (\\>50%) metastatic non-small cell lung cancer without prior PD-(L)1 therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed newly diagnosed or recurrent advanced Non Small Cell Lung Cancer/NSCLC that is PI-L1 high by immunohistochemistry (PD-L1 \\>/= 50%)\n* Intended treatment with a PD-(L)1 inhibitor\n* Age \\>/= 18 years\n* Karnofsky Performance Status \\>/= 70% and medically fit to undergo a biopsy procedure\n\nExclusion Criteria:\n\n* Any medical condition or any sites of disease that would preclude a biopsy\n* Pregnant or breastfeeding women\n* Cognitively impairment affecting ability to understand and provide informed consent\n* Prior PD-(L)1 blockade treatment\n* Chemotherapy within 6 months prior to enrollment'}, 'identificationModule': {'nctId': 'NCT03877250', 'briefTitle': 'Analysis of Biopsy Specimens to Study Responses to PD-1 or PD-L1 Therapies', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Characterization of Mechanism of Response to PD-1 Blockade in NSCLC: A Pilot Study', 'orgStudyIdInfo': {'id': '19-030'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non Small Cell Lung Cancer (NSCLC)', 'description': 'Participants with pathologically confirmed newly diagnosed or recurrent advanced NSCLC that is PD-L1 high by immunohistochemistry', 'interventionNames': ['Diagnostic Test: Pre-Treatment Biopsy', 'Diagnostic Test: On-Treatment Biopsy', 'Diagnostic Test: Biopsy at Disease Progression', 'Diagnostic Test: Peripheral Blood-Based Studies']}], 'interventions': [{'name': 'Pre-Treatment Biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants screened for participation will include those with a diagnosis of advanced NSCLC who have undergone a pre-treatment biopsy prior to start of therapy with a PD-(L)1 inhibitor or who are medically able to undergo a biopsy if (1) no pre-treatment biopsy has been obtained and (2) no PD-(L)1 inhibitor has been started.', 'armGroupLabels': ['Non Small Cell Lung Cancer (NSCLC)']}, {'name': 'On-Treatment Biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'All participants who receive at least 1 dose of PD-(L)1 inhibitor will be referred for a biopsy. The biopsy should be obtained within 4 weeks of first on-treatment imaging (usually performed \\~6-9 weeks after beginning therapy) and will be performed in participants regardless of radiologic response.', 'armGroupLabels': ['Non Small Cell Lung Cancer (NSCLC)']}, {'name': 'Biopsy at Disease Progression', 'type': 'DIAGNOSTIC_TEST', 'description': 'All participants who develop disease progression after initial response to PD-(L)1 blockade will be considered for an additional, optional biopsy. Biopsies at disease progression are often obtained per standard of care within 4 weeks of documented progression on imaging and prior to the initiation of further systemic therapy.', 'armGroupLabels': ['Non Small Cell Lung Cancer (NSCLC)']}, {'name': 'Peripheral Blood-Based Studies', 'type': 'DIAGNOSTIC_TEST', 'description': 'All participants will have peripheral blood obtained on Day 1 of cycles 1-4 (0, 3, 6, and 9 weeks). At each time point, peripheral blood sample will be collected pre-treatment and used for analysis of T cell subsets and TCR sequencing.', 'armGroupLabels': ['Non Small Cell Lung Cancer (NSCLC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memoral Sloan Kettering Basking Ridge (Consent and Follow up)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memoral Sloan Kettering Monmouth (Consent and Follow up)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Bergen (Consent and Follow up)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center @ Suffolk (Consent Only)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Memoral Sloan Kettering Westchester (Consent & Follow Up)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan - Kettering Cancer Center (Consent and follow-up)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Matthew Hellmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wang Initiative in Lung Cancer Clinical Trials', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}