Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-01 @ 7:22 PM
Study NCT ID:
NCT06898957
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'C000613593', 'term': 'durvalumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-04-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-03-21', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-04-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Dose-limiting toxicities (DLTs)', 'timeFrame': 'Up to Day 21'}, {'measure': 'Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 3.5 Years'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1', 'timeFrame': 'Up to 3.5 Years'}, {'measure': 'Duration of Response (DOR) per RECIST 1.1', 'timeFrame': 'Up to 3.5 Years'}, {'measure': 'Time to Response (TTR) per RECIST 1.1', 'timeFrame': 'Up to 3.5 Years'}, {'measure': 'Disease Control Rate (DCR) per RECIST 1.1', 'timeFrame': 'Up to 3.5 Years'}, {'measure': 'Progression-free Survival (PFS) per RECIST 1.1', 'timeFrame': 'Up to 3.5 Years'}, {'measure': 'Time to Progression (TTP) per RECIST 1.1', 'timeFrame': 'Up to 3.5 Years'}, {'measure': 'Time to Subsequent Therapy', 'timeFrame': 'Up to 3.5 Years'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 3.5 Years'}, {'measure': 'Maximum Serum Concentration (Cmax) of Tarlatamab', 'timeFrame': 'Up to Week 36'}, {'measure': 'Minimum Serum Concentration (Cmin) of Tarlatamab', 'timeFrame': 'Up to Week 36'}, {'measure': 'Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for Tarlatamab', 'timeFrame': 'Up to Week 36'}, {'measure': 'Half-life (t1/2) of Tarlatamab', 'timeFrame': 'Up to Week 36'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Small cell lung cancer', 'SCLC', 'Tarlatamab', 'YL201', 'Anti-PD-L1', 'Atezolizumab', 'Durvalumab'], 'conditions': ['Small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent.\n* Participants with histologically or cytologically confirmed ES-SCLC.\n* For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.\n* For Part 3, participants must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and PD-(L)1 inhibitor in the first-line setting.\n* At least 1 measurable lesion as defined by RECIST 1.1.\n* Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver).\n\nExclusion Criteria:\n\n* Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy.\n* Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.\n* Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol.\n* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.\n* Baseline requirement of supplemental oxygen.'}, 'identificationModule': {'nctId': 'NCT06898957', 'acronym': '(DeLLphi-310)', 'briefTitle': 'Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With YL201 With or Without Anti-PD-L1 in Subjects With Extensive Stage Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '20240124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Exploration (Part 1)', 'description': 'Multiple dose levels of YL201 will be explored in combination with tarlatamab administered intravenously (IV) at a fixed dose using one-step dosing.', 'interventionNames': ['Drug: YL201', 'Drug: Tarlatamab']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion (Part 2)', 'description': 'YL201 will be administered at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV at a fixed dose.', 'interventionNames': ['Drug: YL201', 'Drug: Tarlatamab']}, {'type': 'EXPERIMENTAL', 'label': 'Triplet Combination (Part 3)', 'description': 'YL201 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (atezolizumab or durvalumab) administered IV at a fixed dose.', 'interventionNames': ['Drug: YL201', 'Drug: Tarlatamab', 'Drug: Atezolizumab', 'Drug: Durvalumab']}], 'interventions': [{'name': 'YL201', 'type': 'DRUG', 'description': 'YL201 will be administered as an IV infusion.', 'armGroupLabels': ['Dose Expansion (Part 2)', 'Dose Exploration (Part 1)', 'Triplet Combination (Part 3)']}, {'name': 'Tarlatamab', 'type': 'DRUG', 'description': 'Tarlatamab will be administered as an IV infusion.', 'armGroupLabels': ['Dose Expansion (Part 2)', 'Dose Exploration (Part 1)', 'Triplet Combination (Part 3)']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'description': 'Atezolizumab will be administered as an IV infusion.', 'armGroupLabels': ['Triplet Combination (Part 3)']}, {'name': 'Durvalumab', 'type': 'DRUG', 'description': 'Durvalumab will be administered as an IV infusion.', 'armGroupLabels': ['Triplet Combination (Part 3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92618', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City of Hope Orange County Lennar Foundation Cancer Center', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Siteman Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sanford Roger Maris Cancer Center', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '54104', 'city': 'Sioux Falls', 'state': 'South Dakota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sanford Oncology Clinic and Pharmacy', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'G1J 1Z4', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'CHU de Quebec Hopital de l Enfant Jesus', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shandong Cancer Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '611135', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '350011', 'city': 'Fuzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Fujian Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '94805', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '57001', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'European Interbalkan Medical Center', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '57001', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'Iatriko Diavalkaniko Thessalonikis', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '3200', 'city': 'Gyöngyös', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'Clinexpert Kft Bugat Pal Korhaz', 'geoPoint': {'lat': 47.78257, 'lon': 19.928}}, {'zip': '10060', 'city': 'Candiolo to', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS'}, {'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Severance Hospital Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitari Vall d Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08041', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Amgen Call Center', 'role': 'CONTACT', 'email': 'medinfo@amgen.com', 'phone': '866-572-6436'}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request .De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MediLink', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}