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

NCT07531095 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 202501142025-522888-15-00
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Small Cell Lung Cancer

Keywords

Tarlatamab; ZL-1310; Durvalumab; SCLC; Anti-PD-L1; Extensive Stage Small Cell Lung Cancer; Programmed death protein-1 (PD-1); Programmed death ligand 1 (PD-L1)

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  Up to 3.5 years

• Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

  Up to Day 21

Secondary Outcomes (9)

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

  Up to 3.5 years

• Duration of Response (DOR) per RECIST v1.1

  Up to 3.5 years

• Time to Response (TTR) per RECIST v1.1

  Up to 3.5 years

• Disease Control Rate (DCR) per RECIST v1.1

  Up to 3.5 years

• Progression-free Survival (PFS) per RECIST v1.1

  Up to 3.5 years

Study Arms (3)

Dose Exploration (Part 1)

EXPERIMENTAL

Multiple dose levels of ZL-1310 will be explored in combination with tarlatamab administered intravenously (IV).

Drug: ZL-1310; Drug: Tarlatamab

Dose Expansion (Part 2)

EXPERIMENTAL

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: ZL-1310; Drug: Tarlatamab

Triplet Combination (Part 3)

EXPERIMENTAL

ZL-1310 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) each administered IV.

Drug: ZL-1310; Drug: Tarlatamab; Drug: Durvalumab

Interventions

ZL-1310 DRUG

ZL-1310 will be administered as an IV infusion.

Dose Expansion (Part 2); Dose Exploration (Part 1); Triplet Combination (Part 3)

Tarlatamab DRUG

Tarlatamab will be administered as an IV infusion.

Also known as: IMDELLTRA

Dose Expansion (Part 2); Dose Exploration (Part 1); Triplet Combination (Part 3)

Durvalumab DRUG

Durvalumab will be administered as an IV infusion.

Triplet Combination (Part 3)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (6)

New York University Cancer Institute

New York, New York, 10016, United States

RECRUITING

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

RECRUITING

Next Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, 01370, Turkey (Türkiye)

RECRUITING

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, 35575, Turkey (Türkiye)

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): May 21, 2028
• Study Completion (Estimated): May 21, 2031
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (3); TU (3)