A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Launched by AMGEN · Jun 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination of two medicines, tarlatamab and AB248, to see if they are safe and well-tolerated in people with extensive stage small cell lung cancer (ES-SCLC) that has come back or gotten worse after previous treatment. The main goal is to find the right dose of these medicines to use together and to understand how the body handles this combination.

People who might be eligible for this study are adults with ES-SCLC who have already tried at least one treatment for their cancer but still have measurable tumors. They need to be in generally good health with working organs like the heart, lungs, liver, and kidneys. Participants will be asked to provide a recent tumor sample unless it's unsafe or impossible, in which case older samples might be used. This trial is not yet recruiting, and it is open to all genders. Important to note, people with certain brain problems or previous treatments similar to tarlatamab cannot join. Participants can expect close monitoring for side effects and careful dose adjustments to find a safe and effective treatment level.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant has provided informed consent before initiation of any study-specific activities/procedures.
• • 2. Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
• • 3. Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC.
• • 4. Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
• • 5. Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).
• • 6. Participants must submit a fresh tumor biopsy at screening unless a new biopsy cannot be performed safely or is infeasible. Participants who cannot provide fresh tissue may provide archival tissue that was collected after last anticancer therapy.
• Exclusion Criteria:
• • 1. Symptomatic central nervous system (CNS) metastases.
• • 2. Participants with brain metastases may be eligible if criteria defined in the protocol are met.
• • 3. Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).
• • 4. Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.
• • 5. Baseline (at rest) requirement of supplemental oxygen.