Tests tarlatamab with ZL-1310 in small cell lung cancer
Tests tarlatamab and ZL-1310, with or without durvalumab, in adults with small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
Key facts
- Where
- Barcelona, Madrid, Málaga, and Valencia, SpainSee the 5 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT07531095, who can take part
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario 12 de OctubreMadrid, SpainTaking people
- Hospital Universitario Ramón y CajalMadrid, SpainTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amgen
- Trial code
- NCT07531095EU 2025-522888-15-00
- Record updated
- 21 August 2026
- Original description
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.Read full original descriptionShow less
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
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: 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: 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; History of interstitial lung disease (ILD)/pneumonitis; 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.