RECRUITING

Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)

Conditions

Small Cell Lung Cancer SCLC Tarlatamab YL201 Anti-PD-L1 Atezolizumab Durvalumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.

Official Title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With YL201 With or Without Anti-PD-L1 in Subjects With Extensive Stage Small Cell Lung Cancer

Quick Facts

Study Start:2025-05-30

Study Completion:2031-04-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06898957

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.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent. * Participants with histologically or cytologically confirmed ES-SCLC. * For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy. * For Part 3, participants must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and PD-(L)1 inhibitor in the first-line setting. * At least 1 measurable lesion as defined by RECIST 1.1. * Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver).	* Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy. * Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload. * Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol. * History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Baseline requirement of supplemental oxygen.

Inclusion Criteria

Exclusion Criteria

* Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent.
* Participants with histologically or cytologically confirmed ES-SCLC.
* For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
* For Part 3, participants must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and PD-(L)1 inhibitor in the first-line setting.
* At least 1 measurable lesion as defined by RECIST 1.1.
* Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver).

* Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy.
* Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
* Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol.
* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* Baseline requirement of supplemental oxygen.

Contacts and Locations

Study Contact

Amgen Call Center

CONTACT

866-572-6436

medinfo@amgen.com

Principal Investigator

STUDY_DIRECTOR

Amgen

Study Locations (Sites)

Washington University

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Amgen

MD, STUDY_DIRECTOR, Amgen

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 Registration Dates

Study Start Date2025-05-30

Study Completion Date2031-04-13

Study Record Updates

Study Start Date2025-05-30

Study Completion Date2031-04-13

Terms related to this study

Keywords Provided by Researchers

Small cell lung cancer
SCLC
Tarlatamab
YL201
Anti-PD-L1
Atezolizumab
Durvalumab

Additional Relevant MeSH Terms

Small Cell Lung Cancer