Small Cell Lung Cancer
Conditions
Keywords
Tarlatamab, ZL-1310, Durvalumab, SCLC, Anti-PD-L1, Extensive Stage Small Cell Lung Cancer, Programmed death protein-1 (PD-1), Programmed death ligand 1 (PD-L1)
Brief 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.
Interventions
DRUGZL-1310
ZL-1310 will be administered as an IV infusion.
DRUGTarlatamab
Tarlatamab will be administered as an IV infusion.
DRUGDurvalumab
Durvalumab will be administered as an IV infusion.
Sponsors
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Up to 3.5 years |
| Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) | Up to Day 21 |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | Up to 3.5 years |
| Duration of Response (DOR) per RECIST v1.1 | Up to 3.5 years |
| Time to Response (TTR) per RECIST v1.1 | Up to 3.5 years |
| Disease Control Rate (DCR) per RECIST v1.1 | Up to 3.5 years |
| Progression-free Survival (PFS) per RECIST v1.1 | Up to 3.5 years |
| Time to Progression (TTP) per RECIST v1.1 | Up to 3.5 years |
| Time to Subsequent Therapy | Up to 3.5 years |
| Overall survival (OS) | Up to 3.5 years |
| Serum Tarlatamab Concentrations | Up to Week 36 |
Countries
Australia, Belgium, France, Germany, Poland, Spain, Switzerland, Turkey (Türkiye), United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed