RecruitingPhase 1NCT07531095

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

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.

Checked against the public recordLast updated Aug 21, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 1
U.S. locations27
SponsorAmgen
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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Amgen
Interventions being studied
Drug: ZL-1310; Drug: Tarlatamab; Drug: Durvalumab
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
Treatment approach
03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • City of Hope Cancer Center PhoenixGoodyear, Arizona
  • Moffitt Cancer CenterTampa, Florida
  • City of Hope ChicagoZion, Illinois
  • Health Partners Cancer Center at Regions HospitalSaint Paul, Minnesota
  • New York University Cancer InstituteNew York, New York
  • Baptist Cancer CenterMemphis, Tennessee
  • Next VirginiaFairfax, Virginia
  • Monash Medical CentreClayton, Victoria
  • Institut Jules BordetBrussels
  • Universitair Ziekenhuis GentGhent
  • Ziekenhuis aan de Stroom AugustinusWilrijk
  • Centre Hospitalier Universitaire de Lyon Hopital Louis PradelBron

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 21, 2026. Always confirm current availability with the study team.

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