Clinical Trials in Spain / NCT06898957
Active, not recruiting
Phase 1
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)
NCT06898957 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Small Cell Lung Cancer
Investigational drug(s) / intervention(s)
YL201: YL201 will be administered as an IV infusion.
Tarlatamab: Tarlatamab will be administered as an IV infusion.
Durvalumab: Durvalumab will be administered as an IV infusion.
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
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, subjects must have ES-SCLC that has progressed or recurred following at least 1 prior line of platinum-based anti-cancer therapy received either for LS-SCLC or ES-SCLC.
* For Part 3, subjects must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, and etoposide, and with or without 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.
Primary outcome measure(s)
- 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
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope Orange County Lennar Foundation Cancer Center | Irvine | California | |
| Yale New Haven Hospital | New Haven | Connecticut | |
| Moffitt Cancer Center | Tampa | Florida | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Siteman Cancer Center | St Louis | Missouri | |
| Sanford Roger Maris Cancer Center | Fargo | North Dakota | |
| Cleveland Clinic Foundation | Cleveland | Ohio | |
| Sanford Oncology Clinic and Pharmacy | Sioux Falls | South Dakota | |
| University of Texas MD Anderson Cancer Center | Houston | Texas | |
| Swedish Medical Center | Seattle | Washington | |
| Fred Hutchinson Cancer Center | Seattle | Washington | |
| CHU de Quebec Hopital de l Enfant Jesus | Québec | Quebec | |
| Shandong Cancer Hospital | Jinan | Shandong | |
| West China Hospital of Sichuan University | Chengdu | Sichuan | |
| 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 | |
| Henry Dunant Hospital Center | Athens | Greece | |
| Alexandra Hospital | Athens | Greece | |
| European Interbalkan Medical Center | Thessaloniki | Greece | |
| Iatriko Diavalkaniko Thessalonikis | Thessaloniki | Greece | |
| Semmelweis Egyetem | Budapest | Hungary | |
| Clinexpert Kft Bugat Pal Korhaz | Gyöngyös | Hungary | |
| Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS | Candiolo to | Italy | |
| Istituto Romagnolo per lo Studio dei Tumori Dino Amadori | Meldola (FC) | Italy | |
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | Milan | Italy | |
| Seoul National University Hospital | Seoul | South Korea | |
| Severance Hospital Yonsei University Health System | Seoul | South Korea | |
| Asan Medical Center | Seoul | South Korea | |
| Hospital Universitari Vall d Hebron | Barcelona | Catalonia | |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Catalonia | |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
On this site
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06898957 on ClinicalTrials.gov ↗ ← All trials in Spain