Extensive Stage Small Cell Lung Cancer
Conditions
Keywords
Small Cell Lung Cancer
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
Interventions
DRUGTarlatamab
Administered by SC injection.
Sponsors
Amgen
BeOne Medicines
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent. * Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC. Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. * Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver). * Participants must be able to have SC injections administered in the abdomen. * Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.
Exclusion criteria
* Participants that have received prior DLL3 targeted therapy. * Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids. * Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment). * Participants with leptomeningeal disease. * Participants with baseline oxygen requirement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Dose-limiting toxicities (DLTs) | Up to day 21 |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to approximately 24 months |
| Number of Participants with Changes in Vital Signs | Up to approximately 24 months |
| Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests | Up to approximately 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Serum Concentration (Cmax) of Tarlatamab | Up to approximately 12 months |
| Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab | Up to approximately 12 months |
| Time to Cmax (Tmax) of Tarlatamab | Up to approximately 12 months |
| Area Under the Concentration-time Curve (AUC) of Tarlatamab | Up to approximately 12 months |
| Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Up to approximately 24 months |
| Duration of Response (DOR) per RECIST 1.1 | Up to approximately 24 months |
| Time to Response (TTR) per RECIST 1.1 | Up to approximately 24 months |
| Progression-free Survival (PFS) per RECIST 1.1 | Up to approximately 24 months |
| Time to Progression per RECIST 1.1 | Up to approximately 24 months |
| Time to Subsequent Therapy | Up to approximately 24 months |
| Overall Survival (OS) | Up to approximately 24 months |
| Number of Participants with Anti-tarlatamab Antibody Formation | Up to approximately 24 months |
Countries
Australia, Belgium, China, Germany, Japan, Poland, Spain, Switzerland, Turkey (Türkiye), United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed