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NCT07037758From ClinicalTrials.govRecruiting

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

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

  • Extensive Stage Small Cell Lung Cancer

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Amgen
Enrolment target
380
Started
16 September 2025
Main results due
18 March 2028
Study sites
19
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 90 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.

The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.

Study sites(19)

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, United States

    Terminated

  • University of Southern California, Norris Comprehensive Cancer Center

    Los Angeles, California, United States

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, United States

    Recruiting

  • Emory University

    Atlanta, Georgia, United States

    Recruiting

  • Norton Cancer Institute - Downtown

    Louisville, Kentucky, United States

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, United States

    Recruiting

  • Siteman Cancer Center

    St Louis, Missouri, United States

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

    Recruiting

  • Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, United States

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, United States

    Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, United States

    Recruiting

  • Baptist Cancer Center

    Memphis, Tennessee, United States

    Recruiting

  • Swedish Cancer Institute Medical Oncology

    Seattle, Washington, United States

    Recruiting

  • Chungbuk National University Hospital

    Cheongju Chungbuk, South Korea

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, South Korea

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, South Korea

    Recruiting

  • Adana Sehir Egitim ve Arastirma Hastanesi

    Adana, Turkey (Türkiye)

    Recruiting

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, Turkey (Türkiye)

    Recruiting

  • Ankara Bilkent Sehir Hastanesi

    Ankara, Turkey (Türkiye)

    Recruiting

Showing 19 of 19 sites. 18 of the 19 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07037758. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (D | Trialion