Recruiting NCT07531095
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZL-1310, Tarlatamab, Durvalumab.
- Who it may be relevant to
- Registry conditions: Small Cell Lung Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, France, Germany, Poland +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer
Overview
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.
Interventions
- Drug ZL-1310
ZL-1310 will be administered as an IV infusion. - Drug Tarlatamab
Tarlatamab will be administered as an IV infusion. - Drug Durvalumab
Durvalumab will be administered as an IV infusion.
Primary outcome measures
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to 3.5 years]
- Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) [Time frame: Up to Day 21]
Secondary outcome measures (9)
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [Time frame: Up to 3.5 years]
- Duration of Response (DOR) per RECIST v1.1 [Time frame: Up to 3.5 years]
- Time to Response (TTR) per RECIST v1.1 [Time frame: Up to 3.5 years]
- Disease Control Rate (DCR) per RECIST v1.1 [Time frame: Up to 3.5 years]
- Progression-free Survival (PFS) per RECIST v1.1 [Time frame: Up to 3.5 years]
- Time to Progression (TTP) per RECIST v1.1 [Time frame: Up to 3.5 years]
- Time to Subsequent Therapy [Time frame: Up to 3.5 years]
- Overall survival (OS) [Time frame: Up to 3.5 years]
- Serum Tarlatamab Concentrations [Time frame: Up to Week 36]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 7 centers
- City of Hope Cancer Center Phoenix — Goodyear
- Moffitt Cancer Center — Tampa
- City of Hope Chicago — Zion
- Health Partners Cancer Center at Regions Hospital — Saint Paul
- New York University Cancer Institute — New York
- Baptist Cancer Center — Memphis
- Next Virginia — Fairfax
Spain · 5 centers
- Hospital Clinico Universitario Virgen de la Victoria — Málaga
- Hospital Universitari Vall d Hebron — Barcelona
- Hospital Clinico Universitario de Valencia — Valencia
- Hospital Universitario Ramon y Cajal — Madrid
- Hospital Universitario 12 de Octubre — Madrid
Turkey (Türkiye) · 3 centers
- Adana Sehir Egitim ve Arastirma Hastanesi — Adana
- Hacettepe Universitesi Tip Fakultesi Hastanesi — Ankara
- Izmir Ekonomi Universitesi Medical Point Hastanesi — Izmir
Belgium · 2 centers
- Universitair Ziekenhuis Gent — Ghent
- Ziekenhuis aan de Stroom Augustinus — Wilrijk
France · 2 centers
- Hopital de la Timone — Marseille
- Gustave Roussy — Villejuif
Germany · 2 centers
- Universitaetsklinikum Dresden — Dresden
- Universitaetsklinikum Wuerzburg — Würzburg
Poland · 2 centers
- Uniwersyteckie Centrum Kliniczne — Gdansk
- Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy — Gliwice
Switzerland · 1 center
- Kantonsspital Sankt Gallen — Sankt Gallen
Identifiers
NCT: NCT07531095 · 20250114 · 2025-522888-15-00