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)

Last updated: May 11, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

1

Condition

Small Cell Lung Cancer

Treatment

Durvalumab

YL201

Atezolizumab

Clinical Study ID

NCT06898957
20240124
  • Ages 18-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants ≥ 18 years of age (or legal adult age within country) at time ofsigning informed consent.

  • Participants with histologically or cytologically confirmed ES-SCLC.

  • For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurredfollowing at least 1 line of platinum-based anti-cancer therapy.

  • For Part 3, participants must have ES-SCLC and no prior systemic treatment for ESSCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and PD-(L)1inhibitor 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, bonemarrow, and liver).

Exclusion

Exclusion Criteria:

  • 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) withtopoisomerase I inhibitor payload.

  • Symptomatic central nervous system (CNS) metastases. Note: Participants withasymptomatic brain metastases are eligible as defined in the protocol.

  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis thatrequired corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis thatcannot be ruled out by imaging at screening.

  • Baseline requirement of supplemental oxygen.

Study Design

Total Participants: 200
Treatment Group(s): 4
Primary Treatment: Durvalumab
Phase: 1
Study Start date:
May 30, 2025
Estimated Completion Date:
April 13, 2031

Connect with a study center

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Active - Recruiting

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.