(DeLLphi-310)Tarlatamab and YL201 in Extensive Stage Small Cell Lung Cancer
YL201
+ Tarlatamab
+ Atezolizumab
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Lung Diseases
Treatment Study
Summary
Study start date: May 16, 2025
Actual date on which the first participant was enrolled.This study focuses on testing the safety and how well people can handle a combination of drugs, specifically tarlatamab and YL201, sometimes adding another drug called anti-PD-L1. It targets individuals with extensive stage small cell lung cancer, a form of cancer that requires more effective treatments. This research is important because it explores new combinations of medications that might better control the disease and improve patient outcomes, addressing the need for more treatment options. Participants in this study will receive these medications possibly through injections or other methods as determined by the researchers. The study is designed to carefully observe any side effects or reactions to these drugs, making sure they are safe for use. Although the potential benefits include finding a more effective treatment for this type of lung cancer, risks involve typical drug-related side effects, which the study aims to monitor closely.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 99 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 36 locations
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, United StatesOpen City of Hope Orange County Lennar Foundation Cancer Center in Google MapsYale New Haven Hospital
New Haven, United StatesMoffitt Cancer Center
Tampa, United StatesDana Farber Cancer Institute
Boston, United States