RecruitingPhase 1NCT07531095

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

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

Sponsor

Amgen

Enrollment

160 participants

Start Date

Apr 21, 2026

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer

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

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria9

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 Criteria7

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.