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Tarlatamab plus AB248 for 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)

Phase 1 Interventional Amgen · NCT07037758

This trial tests whether combining tarlatamab with AB248 is safe and tolerable for adults whose extensive-stage small cell lung cancer has progressed after prior therapy.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment380 (estimated)
Ages18 Years to 90 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionstarlatamab
Locations19 sites (Gilbert, Arizona and 18 other locations)
Trial IDNCT07037758 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label dose-exploration and expansion trial combines the bispecific T-cell engager tarlatamab with AB248 in adults with extensive-stage small cell lung cancer that progressed after at least one prior systemic therapy. During dose exploration the study will escalate AB248 to determine the recommended dose for expansion and the maximum tolerated combination dose when given with tarlatamab, followed by dose expansion cohorts to further characterize safety and preliminary activity. Key requirements include measurable disease per RECIST 1.1, adequate organ function, and submission of a fresh tumor biopsy when feasible. The trial is sponsored by Amgen with collaborating sites at major US cancer centers.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed extensive-stage SCLC that progressed after at least one prior anti-cancer therapy, who have measurable disease, adequate organ function, and can provide a tumor biopsy are the intended participants.

Not a fit: Patients with symptomatic central nervous system metastases, significant organ dysfunction, or who cannot undergo the required biopsy or travel to trial sites are unlikely to benefit and may be ineligible.

Why it matters

Potential benefit: If successful, this combination could provide a new treatment option that improves disease control for patients with recurrent extensive-stage small cell lung cancer.

How similar studies have performed: Tarlatamab (AMG 757) has shown promising single-agent activity in prior trials of extensive-stage SCLC, but combining it with AB248 is a novel approach that has not been established.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Gilbert, Arizona and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Extensive Stage Small Cell Lung CancerES-SCLCTarlatamabAMG 757AB248Imdelltra
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.