Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) (DeLLphi-313)

May 20, 2026 updated by: Amgen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe Universitesi Tip Fakultesi Hastanesi
      • Izmir, Turkey (Türkiye), 35575
        • Recruiting
        • Izmir Ekonomi Universitesi Medical Point Hastanesi
  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • New York University Cancer Institute
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Exploration (Part 1)
Multiple dose levels of ZL-1310 will be explored in combination with tarlatamab administered intravenously (IV).
Drug: Tarlatamab
Tarlatamab will be administered as an IV infusion.
Other Names:
  • IMDELLTRA
Drug: ZL-1310
ZL-1310 will be administered as an IV infusion.
Experimental: Dose Expansion (Part 2)
ZL-1310 will be administered IV at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV.
Drug: Tarlatamab
Tarlatamab will be administered as an IV infusion.
Other Names:
  • IMDELLTRA
Drug: ZL-1310
ZL-1310 will be administered as an IV infusion.
Experimental: Triplet Combination (Part 3)
ZL-1310 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) each administered IV.
Drug: Tarlatamab
Tarlatamab will be administered as an IV infusion.
Other Names:
  • IMDELLTRA
Drug: Durvalumab
Durvalumab will be administered as an IV infusion.
Drug: ZL-1310
ZL-1310 will be administered as an IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 3.5 years
Up to 3.5 years
Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Time Frame: Up to Day 21
Up to Day 21

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time Frame: Up to 3.5 years
Up to 3.5 years
Duration of Response (DOR) per RECIST v1.1
Time Frame: Up to 3.5 years
Up to 3.5 years
Time to Response (TTR) per RECIST v1.1
Time Frame: Up to 3.5 years
Up to 3.5 years
Disease Control Rate (DCR) per RECIST v1.1
Time Frame: Up to 3.5 years
Up to 3.5 years
Progression-free Survival (PFS) per RECIST v1.1
Time Frame: Up to 3.5 years
Up to 3.5 years
Time to Progression (TTP) per RECIST v1.1
Time Frame: Up to 3.5 years
Up to 3.5 years
Time to Subsequent Therapy
Time Frame: Up to 3.5 years
Up to 3.5 years
Overall survival (OS)
Time Frame: Up to 3.5 years
Up to 3.5 years
Serum Tarlatamab Concentrations
Time Frame: Up to Week 36
Up to Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2026

Primary Completion (Estimated)

May 21, 2028

Study Completion (Estimated)

May 21, 2031

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20250114
  • 2025-522888-15-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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