Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
Recruiting now · Phase 1
Conditions studied: Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT07531095
- Run by
- Amgen
- People needed
- 160
- Starts
- 2026-04-21
- Expected to finish
- 2031-05-21
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- City of Hope Cancer Center Phoenix — Goodyear, Arizona, United States (enrolling)
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- City of Hope Chicago — Zion, Illinois, United States (enrolling)
- Health Partners Cancer Center at Regions Hospital — Saint Paul, Minnesota, United States (enrolling)
- New York University Cancer Institute — New York, New York, United States (enrolling)
- Baptist Cancer Center — Memphis, Tennessee, United States (enrolling)
- Next Virginia — Fairfax, Virginia, United States (enrolling)
- Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
- Ziekenhuis aan de Stroom Augustinus — Wilrijk, Belgium (enrolling)
- Hopital de la Timone — Marseille, France (enrolling)
- Gustave Roussy — Villejuif, France (enrolling)
- Universitaetsklinikum Dresden — Dresden, Germany (enrolling)
- Universitaetsklinikum Wuerzburg — Würzburg, Germany (enrolling)
- Uniwersyteckie Centrum Kliniczne — Gdansk, Poland (enrolling)
- Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy — Gliwice, Poland (enrolling)
- Hospital Clinico Universitario Virgen de la Victoria — Málaga, Andalusia, Spain (enrolling)
- Hospital Universitari Vall d Hebron — Barcelona, Catalonia, Spain (enrolling)
- Hospital Clinico Universitario de Valencia — Valencia, Valencia, Spain (enrolling)
- Hospital Universitario Ramon y Cajal — Madrid, Spain (enrolling)
- Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
- Kantonsspital Sankt Gallen — Sankt Gallen, Switzerland (enrolling)
- Adana Sehir Egitim ve Arastirma Hastanesi — Adana, Turkey (Türkiye) (enrolling)
- Hacettepe Universitesi Tip Fakultesi Hastanesi — Ankara, Turkey (Türkiye) (enrolling)
- Izmir Ekonomi Universitesi Medical Point Hastanesi — Izmir, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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