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NCT06898957 | RECRUITING | Small Cell Lung Cancer

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)
Sponsor:

Amgen

Brief 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.

Condition or disease

Small Cell Lung Cancer

Intervention/treatment

YL201

Tarlatamab

Atezolizumab

Durvalumab

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-05-16
Estimated Primary Completion Date : 2031-04-13
Estimated Study Completion Date : 2031-04-13

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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).
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) 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.
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)

Location Details

NCT06898957

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Connecticut

Yale New Haven Hospital

New Haven, Connecticut, United States, 06510

RECRUITING

United States, Missouri

Siteman Cancer Center

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, Texas

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Washington

Swedish Medical Center

Seattle, Washington, United States, 98104

RECRUITING

China, Shandong

Shandong Cancer Hospital

Women, Shandong, China, 250117

RECRUITING

China, Sichuan

West China Hospital of Sichuan University

Chengdu, Sichuan, China, 611135

RECRUITING

China,

Fujian Cancer Hospital

F U-axis, China, 350011