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Hastanesi","Ankara","06230",{"type":61,"coordinates":307},[308,309],32.85427,39.91987,{"lat":309,"lon":308},{"facility":312,"status":54,"city":313,"state":30,"zip":314,"country":296,"countryCode":30,"cosmosGeoPoint":315,"geoPoint":319,"contacts":30},"Izmir Ekonomi Universitesi Medical Point Hastanesi","Izmir","35575",{"type":61,"coordinates":316},[317,318],27.13838,38.41273,{"lat":318,"lon":317},{"type":321,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100633777","phase-1-study-of-tarlatamab--zl-1310---anti-programmed-death-ligand-1-anti-pd-l1-in-small-cell-lung-cancer-sclc-100633777",false,"NCT07531095","Study of Tarlatamab + ZL-1310 +\u002F- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)","A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer","DeLLphi-313","Inclusion Criteria:\n\n* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.\n* Participants with Histologically or cytologically confirmed SCLC:\n* For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.\n* For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1.\n* For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy.\n\nNote: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated.\n* Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function).\n\nExclusion Criteria:\n\n* Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.\n* History of interstitial lung disease (ILD)\u002Fpneumonitis.\n* Received thoracic radiation therapy within 90 days prior to first dose of trial intervention.\n* Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy.\n* Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.\n* Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment.\n* Enrollment in any tarlatamab clinical trial.","ALL","18 Years","99 Years",{"count":334,"type":335},160,"ESTIMATED","INTERVENTIONAL",[338],"PHASE1","The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and\u002For recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.",[341],"Small Cell Lung Cancer",[32,27,38,343,344,345,346,347],"SCLC","Anti-PD-L1","Extensive Stage Small Cell Lung Cancer","Programmed death protein-1 (PD-1)","Programmed death ligand 1 (PD-L1)","2026-08-20",{"date":350,"type":351},"2026-08-21","ACTUAL",{"date":353,"type":351},"2026-04-21",{"date":355,"type":335},"2031-05-21",{"name":5,"class":6},27]