Study of Tarlatamab + ZL-1310 +/- Durvalumab for Small Cell Lung Cancer

This study is testing new combinations of medicines for people with Small Cell Lung Cancer (SCLC) that has progressed after at least one platinum-based chemotherapy. Researchers want to see how safe and tolerable tarlatamab and ZL-1310 are when given together, sometimes with an additional medicine called durvalumab. They also want to find the best dose of ZL-1310 to use with tarlatamab. You may be able to join if you are 18 years or older and have SCLC that has progressed. The main goal is to track any side effects you might experience. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 160 participants. It will evaluate different combinations of tarlatamab, ZL-1310, and durvalumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events (side effects) for up to 3.5 years.

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NCT07531095

Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)

Recruiting
PHASE1Ages 18–99InterventionalTreatment
Amgen
~160 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:ZL-1310TarlatamabDurvalumab

At a glance

Recruiting sites
27 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Measured over Up to 3.5 years
+1 more outcome measured
Small Cell Lung Cancer
27 sites across 18 states
Belgium3
France3
Turkey (Türkiye)3
Germany2
Poland2
Spain2
Arizona1
Florida1
  • MD · STUDY_DIRECTOR · Amgen

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Eligibility criteria

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.
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

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.
  • Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)Up to 3.5 years
  • Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)Up to Day 21