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
- Gdansk, Gliwice, and Warsaw, PolandSee the 3 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with small cell lung cancer, either after at least 1 line of platinum-based treatment or newly diagnosed extensive-stage disease with at most 1 cycle of platinum chemotherapy. It tests tarlatamab with ZL-1310, with or without durvalumab.
- Age
- 18 years or older (or the legal age in the country if it is higher). Up to 99 years.
- Sex
- All sexes can join.
- Disease stage
- Small cell lung cancer confirmed by tissue or cell tests. Parts 1 and 2: the cancer grew or came back after at least 1 line of platinum-based treatment. Part 3: extensive-stage disease. At least 1 measurable tumour that has not had radiation. Good daily function (ECOG 0-1).
- Earlier treatment
- Parts 1 and 2: at least 1 line of platinum-based treatment before. Part 3: no earlier treatment except 1 cycle of platinum-based chemotherapy. Earlier treatment for limited-stage disease is allowed. No earlier DLL3-directed therapy. No earlier topoisomerase I inhibitor or antibody-drug conjugate with that kind of payload. No earlier tarlatamab in Cohort 2-1.
Main reasons for not taking part
- Brain metastases that cause symptoms
- History of interstitial lung disease or pneumonitis
- Chest radiation within 90 days before the first dose
- Strong CYP3A4 or CYP2D6 inhibitor medicines within 14 days or 5 half-lives before the first dose
- Already taking part in any tarlatamab trial
Read by machine on 9 November 2026.
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 Poland
- Uniwersyteckie Centrum KliniczneGdansk, PolandTaking people
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyGliwice, PolandTaking people
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, PolandTaking 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.