Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:40 PM
Study NCT ID:
NCT07468656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCLC Tarlatamab Blood Collection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of blood samples collected to better characterize tarlatamab in real-world setting', 'timeFrame': 'Days 1, 8, and 15 of tarlatamab and after each interval scan for disease assessment', 'description': 'Studies to better understand tarlatamab may include, but are not limited to, the following: 1) predictors of response to treatment with tarlatamab, 2) identification of predictive biomarkers for the development of cytokine release syndrome (CRS) and/or immune effector cell-associated neurotoxicity syndrome (ICANS), 3) characterization of the immune cell environment induced by tarlatamab, 4) identification of resistance mechanisms to tarlatamab treatment, and 5) development of potential translational correlates.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small-cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The overall objective of this project is to prospectively collect blood samples throughout treatment with tarlatamab in patients with small cell lung cancer (SCLC). These samples will then be analyzed through a variety of assays to better characterize tarlatamab in the real-world setting.\n\nThe investigators will prospectively collect blood samples from 25 patients on days 1, 8, and 15 of tarlatamab treatment, as well as after each interval scan for disease monitoring. The investigators will also collect patient data including demographics and baseline characteristics, primary diagnosis, treatment history, and disease monitoring and progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with small cell lung cancer (SCLC) who are eligible for treatment with tarlatamab', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically documented small cell lung cancer (SCLC) or neuroendocrine tumor\n* Appropriate candidate for treatment with tarlatamab based on investigator discretion\n* Age \\> 18 years\n* Signed written informed consent including HIPAA according to institutional guidelines\n\nExclusion Criteria:\n\n* Does not meet all inclusion criteria'}, 'identificationModule': {'nctId': 'NCT07468656', 'briefTitle': 'SCLC Tarlatamab Blood Collection', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Analysis of Blood Samples in Small Cell Lung Cancer Patients Treated With Tarlatamab', 'orgStudyIdInfo': {'id': 'Pro00119597'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Laura Alder, MD', 'role': 'CONTACT', 'email': 'laura.alder@duke.edu', 'phone': '+1 919 862 5400'}, {'name': 'Daniel Hess, MD, PhD', 'role': 'CONTACT', 'email': 'daniel.hess@duke.edu', 'phone': '+1 919 684 8111'}], 'overallOfficials': [{'name': 'Laura Alder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}