Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)

Phase
Recruitment status
Participants
Lead sponsor
Start date
Number of sites

Summary
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.
Acronym
Short title
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
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

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design

  1. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Up to 3.5 years

  2. Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

    Timeframe: Up to Day 21

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Timeframe: Up to 3.5 years

  2. Duration of Response (DOR) per RECIST v1.1

    Timeframe: Up to 3.5 years

  3. Time to Response (TTR) per RECIST v1.1

    Timeframe: Up to 3.5 years

  4. Disease Control Rate (DCR) per RECIST v1.1

    Timeframe: Up to 3.5 years

  5. Progression-free Survival (PFS) per RECIST v1.1

    Timeframe: Up to 3.5 years

  6. Time to Progression (TTP) per RECIST v1.1

    Timeframe: Up to 3.5 years

  7. Time to Subsequent Therapy

    Timeframe: Up to 3.5 years

  8. Overall survival (OS)

    Timeframe: Up to 3.5 years

  9. Serum Tarlatamab Concentrations

    Timeframe: Up to Week 36

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No

  • 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).

  • 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.
Sources for eligibility

  • City of Hope Cancer Center PhoenixGoodyear, United StatesRecruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • City of Hope ChicagoZion, United StatesRecruiting
  • Health Partners Cancer Center at Regions HospitalSaint Paul, United StatesRecruiting
  • New York University Cancer InstituteNew York, United StatesRecruiting
  • Baptist Cancer CenterMemphis, United StatesRecruiting
  • Next VirginiaFairfax, United StatesRecruiting
  • Monash Medical CentreClayton, AustraliaRecruiting
  • Institut Jules BordetBrussels, BelgiumRecruiting
  • Universitair Ziekenhuis GentGhent, BelgiumRecruiting
  • Ziekenhuis aan de Stroom AugustinusWilrijk, BelgiumRecruiting
  • Centre Hospitalier Universitaire de Lyon Hopital Louis PradelBron, FranceRecruiting
  • Hopital de la TimoneMarseille, FranceRecruiting
  • Gustave RoussyVillejuif, FranceRecruiting
  • Universitaetsklinikum DresdenDresden, GermanyRecruiting
  • Universitaetsklinikum WuerzburgWürzburg, GermanyRecruiting
  • Uniwersyteckie Centrum KliniczneGdansk, PolandRecruiting
  • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyGliwice, PolandRecruiting
  • Hospital Clinico Universitario Virgen de la VictoriaMálaga, SpainRecruiting
  • Hospital Universitari Vall d HebronBarcelona, SpainRecruiting
  • Hospital Clinico Universitario de ValenciaValencia, SpainRecruiting
  • Hospital Universitario Ramon y CajalMadrid, SpainRecruiting
  • Hospital Universitario 12 de OctubreMadrid, SpainRecruiting
  • Kantonsspital Sankt GallenSankt Gallen, SwitzerlandRecruiting
  • Adana Sehir Egitim ve Arastirma HastanesiAdana, Turkey (Türkiye)Recruiting

And 2 more, listed on the interactive page.

Sources for sites

  • 2025
  • 2025-522888-15-00
Sources for references

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (5)