Tarlatamab plus ZL-1310, with or without durvalumab, for small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, dose-escalation trial that gives tarlatamab together with ZL-1310, and in some cohorts adds the anti–PD-L1 antibody durvalumab, to find the maximum tolerated combination dose and a recommended Phase 2 dose. Participants are enrolled in defined parts/cohorts based on prior therapies, with some cohorts limited to patients who have progressed after at least one line of platinum-based therapy and a part enrolling extensive-stage patients with minimal prior systemic treatment. Key eligibility includes histologically confirmed small cell lung cancer, ECOG 0–1, at least one measurable lesion per RECIST v1.1, and adequate organ function. Safety, tolerability, and dose-limiting toxicities are the primary focus, with imaging and clinical follow-up to monitor responses and adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

• City of Hope Cancer Center Phoenix
  Goodyear, Arizona, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• City of Hope Chicago
  Zion, Illinois, United States Recruiting
• Health Partners Cancer Center at Regions Hospital
  Saint Paul, Minnesota, United States Recruiting
• New York University Cancer Institute
  New York, New York, United States Recruiting
• Baptist Cancer Center
  Memphis, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.