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)
(DeLLphi-310)
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
1 other identifier
interventional
200
10 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2025
Longer than P75 for phase_1
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2025
CompletedFirst Posted
Study publicly available on registry
March 27, 2025
CompletedStudy Start
First participant enrolled
May 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 23, 2031
April 22, 2026
April 1, 2026
6.1 years
March 21, 2025
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants Experiencing Dose-limiting toxicities (DLTs)
Up to Day 21
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Up to 3.5 Years
Secondary Outcomes (12)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Up to 3.5 Years
Duration of Response (DOR) per RECIST 1.1
Up to 3.5 Years
Time to Response (TTR) per RECIST 1.1
Up to 3.5 Years
Disease Control Rate (DCR) per RECIST 1.1
Up to 3.5 Years
Progression-free Survival (PFS) per RECIST 1.1
Up to 3.5 Years
- +7 more secondary outcomes
Study Arms (3)
Dose Exploration (Part 1)
EXPERIMENTALMultiple dose levels of YL201 will be explored in combination with tarlatamab administered intravenously (IV) at a fixed dose using one-step dosing.
Dose Expansion (Part 2)
EXPERIMENTALYL201 will be administered at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV at a fixed dose.
Triplet Combination (Part 3)
EXPERIMENTALYL201 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (atezolizumab or durvalumab) administered IV at a fixed dose.
Interventions
YL201 will be administered as an IV infusion.
Tarlatamab will be administered as an IV infusion.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Siteman Cancer Center
St Louis, Missouri, 63110, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Sanford Oncology Clinic and Pharmacy
Sioux Falls, South Dakota, 54104, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
CHU de Quebec Hopital de l Enfant Jesus
Québec, Quebec, G1J 1Z4, Canada
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 611135, China
Fujian Cancer Hospital
Fuzhou, 350011, China
Institut Bergonie
Bordeaux, 33000, France
Centre Leon Berard
Lyon, 69373, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059, France
Gustave Roussy
Villejuif, 94805, France
Universitaetsklinikum Essen
Essen, 45147, Germany
Henry Dunant Hospital Center
Athens, 11526, Greece
Alexandra Hospital
Athens, 11528, Greece
European Interbalkan Medical Center
Thessaloniki, 57001, Greece
Iatriko Diavalkaniko Thessalonikis
Thessaloniki, 57001, Greece
Semmelweis Egyetem
Budapest, 1083, Hungary
Clinexpert Kft Bugat Pal Korhaz
Gyöngyös, 3200, Hungary
Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS
Candiolo to, 10060, Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola (FC), 47014, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2025
First Posted
March 27, 2025
Study Start
May 16, 2025
Primary Completion (Estimated)
June 23, 2031
Study Completion (Estimated)
June 23, 2031
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request .De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.