Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
Recruiting · NCT07531095 · Interventional (participants receive a specific treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
- Participants with Histologically or cytologically confirmed SCLC:
- For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
- For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1.
- For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy.
- Note: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated.
- Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function).
Exclusion criteria
- Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.
- History of interstitial lung disease (ILD)/pneumonitis.
- Received thoracic radiation therapy within 90 days prior to first dose of trial intervention.
- Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy.
- Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
- Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment.
- Enrollment in any tarlatamab clinical trial.
Where it is running
27 locations listed across 7 US states.
- City of Hope Cancer Center Phoenix - Goodyear, Arizona, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- City of Hope Chicago - Zion, Illinois, United States
- Health Partners Cancer Center at Regions Hospital - Saint Paul, Minnesota, United States
- New York University Cancer Institute - New York, New York, United States
- Baptist Cancer Center - Memphis, Tennessee, United States
- Next Virginia - Fairfax, Virginia, United States
- Adana Sehir Egitim ve Arastirma Hastanesi - Adana, Turkey (Türkiye)
- Hacettepe Universitesi Tip Fakultesi Hastanesi - Ankara, Turkey (Türkiye)
- Centre Hospitalier Universitaire de Lyon Hopital Louis Pradel - Bron, France
- Institut Jules Bordet - Brussels, Belgium
- Universitaetsklinikum Dresden - Dresden, Germany
- Uniwersyteckie Centrum Kliniczne - Gdansk, Poland
- Universitair Ziekenhuis Gent - Ghent, Belgium
- Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy - Gliwice, Poland
- Izmir Ekonomi Universitesi Medical Point Hastanesi - Izmir, Turkey (Türkiye)
- Hospital Universitario Ramon y Cajal - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Hopital de la Timone - Marseille, France
- Kantonsspital Sankt Gallen - Sankt Gallen, Switzerland
- Gustave Roussy - Villejuif, France
- Ziekenhuis aan de Stroom Augustinus - Wilrijk, Belgium
- Universitaetsklinikum Wuerzburg - Würzburg, Germany
- Hospital Clinico Universitario Virgen de la Victoria - Málaga, Andalusia, Spain
- Hospital Universitari Vall d Hebron - Barcelona, Catalonia, Spain
- Hospital Clinico Universitario de Valencia - Valencia, Valencia, Spain
- Monash Medical Centre - Clayton, Victoria, Australia