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NCT07531095Recruiting

Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)

Official recordSimplified version

Summary

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/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.

Inclusion criteria

• Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. • Participants with Histologically or cytologically confirmed SCLC: • For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy. • 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. • For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy. Note: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted. • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. • At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated. • Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function).

Exclusion criteria

• Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol. • History of interstitial lung disease (ILD)/pneumonitis. • Received thoracic radiation therapy within 90 days prior to first dose of trial intervention. • Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy. • Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload. • Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment. • Enrollment in any tarlatamab clinical trial.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 1
Study type
Interventional
Countries
Switzerland, France, Germany, United States, Australia, Belgium, Poland, Spain, Turkey (Türkiye)
Sponsor
Amgen(Industry)
Protocol no.
20250114
Conditions
Small Cell Lung Cancer
Interventions
Drug

Treatments studied

  • ZL-1310
  • Tarlatamab
  • Durvalumab

Locations · 27

  • Sankt Gallen, SwitzerlandKantonsspital Sankt GallenRecruiting at this site
  • Bron, FranceCentre Hospitalier Universitaire de Lyon Hopital Louis PradelRecruiting at this site
  • Marseille, FranceHopital de la TimoneRecruiting at this site
  • Villejuif, FranceGustave RoussyRecruiting at this site
  • Dresden, GermanyUniversitaetsklinikum DresdenRecruiting at this site
  • Würzburg, GermanyUniversitaetsklinikum WuerzburgRecruiting at this site
  • Goodyear, United StatesCity of Hope Cancer Center PhoenixRecruiting at this site
  • Tampa, United StatesMoffitt Cancer CenterRecruiting at this site
  • Zion, United StatesCity of Hope ChicagoRecruiting at this site
  • Saint Paul, United StatesHealth Partners Cancer Center at Regions HospitalRecruiting at this site
  • New York, United StatesNew York University Cancer InstituteRecruiting at this site
  • Memphis, United StatesBaptist Cancer CenterRecruiting at this site
  • Fairfax, United StatesNext VirginiaRecruiting at this site
  • Clayton, AustraliaMonash Medical CentreRecruiting at this site
  • Brussels, BelgiumInstitut Jules BordetRecruiting at this site
  • Ghent, BelgiumUniversitair Ziekenhuis GentRecruiting at this site
  • Wilrijk, BelgiumZiekenhuis aan de Stroom AugustinusRecruiting at this site
  • Gdansk, PolandUniwersyteckie Centrum KliniczneRecruiting at this site
  • Gliwice, PolandNarodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyRecruiting at this site
  • Málaga, SpainHospital Clinico Universitario Virgen de la VictoriaRecruiting at this site
  • Barcelona, SpainHospital Universitari Vall d HebronRecruiting at this site
  • Valencia, SpainHospital Clinico Universitario de ValenciaRecruiting at this site
  • Madrid, SpainHospital Universitario Ramon y CajalRecruiting at this site
  • Madrid, SpainHospital Universitario 12 de OctubreRecruiting at this site
  • Adana, Turkey (Türkiye)Adana Sehir Egitim ve Arastirma HastanesiRecruiting at this site
  • Ankara, Turkey (Türkiye)Hacettepe Universitesi Tip Fakultesi HastanesiRecruiting at this site
  • Izmir, Turkey (Türkiye)Izmir Ekonomi Universitesi Medical Point HastanesiRecruiting at this site

In total, worldwide, all 27 sites listed in the registry are recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: August 21, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other identifiers

  • 2025-522888-15-00 · CTIS number
  • 2025 · NIH grant

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.