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RECRUITINGPhase 1INTERVENTIONAL

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)

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants ≥ 18 years of age (or legal adult age within country) at time of signing willing to sign a consent form. - Participants with diagnosed by tissue sample (biopsy-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 your organs (liver, kidneys, etc.) are working well enough based on blood tests (cardiac, pulmonary, kidney, bone marrow, and liver). Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

YL201

YL201 will be administered as an IV infusion.

DRUG

Tarlatamab

Tarlatamab will be administered as an IV infusion.

DRUG

Atezolizumab

Atezolizumab will be administered as an IV infusion.

DRUG

Durvalumab

Durvalumab will be administered as an IV infusion.

Locations (20)

City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Moffitt Cancer Center
Tampa, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Siteman Cancer Center
St Louis, Missouri, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Sanford Oncology Clinic and Pharmacy
Sioux Falls, South Dakota, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
CHU de Quebec Hopital de l Enfant Jesus
Québec, Quebec, Canada
Shandong Cancer Hospital
Jinan, Shandong, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Fujian Cancer Hospital
Fuzhou, China
Institut Bergonie
Bordeaux, France
Centre Leon Berard
Lyon, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France
Gustave Roussy
Villejuif, France
Universitaetsklinikum Essen
Essen, Germany