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NCT07531095RecruitingPhase 1

Study of Tarlatamab + ZL-1310 +/- 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

Source: ClinicalTrials.gov · Last updated 21 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
160 (estimated)
First submitted
9 Apr 2026
Start date
21 Apr 2026
Primary completion date
21 May 2028
Lead sponsor
Amgen
Diseases
Lung cancer
NCT number
NCT07531095
EU CT number
2025-522888-15-00

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 160
  • From 21 Apr 2026 to the primary completion date, 21 May 2028
  • 29 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • History of interstitial lung disease (ILD)/pneumonitis.

Other

  • Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.
  • Enrollment in any tarlatamab clinical trial.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Medical Centre
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ClaytonAustraliaRecruiting
Institut Jules Bordet
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AnderlechtBelgiumRecruiting
Ziekenhuis Aan De Stroom
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AntwerpBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
Kantonsspital Sankt Gallen
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Sankt GallenSwitzerlandRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Technische Universitaet Dresden
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DresdenGermanyRecruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Hospices Civils de Lyon
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BronFranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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GliwicePolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
NEXT Virginia
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FairfaxUnited StatesRecruiting
City of Hope Cancer Center Phoenix
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GoodyearUnited StatesRecruiting
Baptist Cancer Center
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MemphisUnited StatesRecruiting
New York University Cancer Institute
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New YorkUnited StatesRecruiting
Health Partners Cancer Center at Regions Hospital
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Saint PaulUnited StatesRecruiting
Moffitt Cancer Center
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TampaUnited StatesRecruiting
City of Hope - Chicago
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ZionUnited StatesRecruiting
Adana Sehir Egitim ve Arastirma Hastanesi
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AdanaTurkey (Türkiye)Recruiting
Hacettepe Universitesi Tip Fakultesi Hastanesi
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AnkaraTurkey (Türkiye)Recruiting
Izmir Ekonomi Universitesi Medical Point Hastanesi
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IzmirTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.