NCT07531095PHASE1Recruiting
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
Amgen
Start Date
4/21/2026
Completion Date
5/21/2031
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.
Eligibility Criteria
Age Range: 18 years to 99 years
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.
Interventions
DRUG
ZL-1310
DRUG
Tarlatamab
DRUG
Durvalumab
Conditions
Small Cell Lung Cancer
Locations
New York University Cancer Institute
New York, New York 10016
United States
Baptist Cancer Center
Memphis, Tennessee 38120
United States
Next Virginia
Fairfax, Virginia 22031
United States
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, 01370
Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06230
Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, 35575
Turkey (Türkiye)