Recruiting
Phase 1

Tarlatamab

Sponsor:

Amgen

Code:

NCT06598306

Conditions

Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tarlatamab

Study Details

Brief summary:

The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.

Conditions

Extensive Stage Small Cell Lung Cancer

Study ID

NCT06598306

Start date

Oct 7, 2024

Status verified date

Jun, 2026

Completion date

Apr 24, 2030

Anticipated

Primary completion date

Apr 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.
  • Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC.

Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
  • Participants must be able to have SC injections administered in the abdomen.
  • Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.

Exclusion Criteria:

  • Participants that have received prior DLL3 targeted therapy.
  • Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.
  • Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).
  • Participants with leptomeningeal disease.
  • Participants with baseline oxygen requirement.

Study Design

Enrollment

220 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Part 1 Dose Exploration

Tarlatamab will be administered as a SC injection in Part 1.

experimental: Part 2 Dose Expansion

Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1.

experimental: Part 3 Alternative Dosing

Following the selection of a SC dosing regimen from Part 1 that will be used in Part 2 dose expansion, Part 3 may open to test alternative dosing of SC tarlatamab.

Interventions

Tarlatamab

Administered by SC injection.

Primary outcome measure

  • Number of Participants with Dose-limiting toxicities (DLTs) [ Time Frame: Up to day 21 ]
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 24 months ]
  • Number of Participants with Changes in Vital Signs [ Time Frame: Up to approximately 24 months ]
  • Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [ Time Frame: Up to approximately 24 months ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

University of Southern California, Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Trinity Health Saint Joseph Mercy Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

Amgen

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Small Cell Lung Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-06-26.