Small Cell Lung Cancer
Conditions
Keywords
Small cell lung cancer, SCLC, Tarlatamab, YL201, Anti-PD-L1, Atezolizumab, Durvalumab
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.
Interventions
DRUGYL201
YL201 will be administered as an IV infusion.
DRUGTarlatamab
Tarlatamab will be administered as an IV infusion.
DRUGAtezolizumab
Atezolizumab will be administered as an IV infusion.
DRUGDurvalumab
Durvalumab will be administered as an IV infusion.
Sponsors
Amgen
MediLink
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
* Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent. * Participants with histologically or cytologically confirmed ES-SCLC. * For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy. * For Part 3, participants must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and PD-(L)1 inhibitor in the first-line setting. * At least 1 measurable lesion as defined by RECIST 1.1. * Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver).
Exclusion criteria
* Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy. * Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload. * Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol. * History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Baseline requirement of supplemental oxygen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Dose-limiting toxicities (DLTs) | Up to Day 21 |
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Up to 3.5 Years |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Up to 3.5 Years |
| Duration of Response (DOR) per RECIST 1.1 | Up to 3.5 Years |
| Time to Response (TTR) per RECIST 1.1 | Up to 3.5 Years |
| Disease Control Rate (DCR) per RECIST 1.1 | Up to 3.5 Years |
| Progression-free Survival (PFS) per RECIST 1.1 | Up to 3.5 Years |
| Time to Progression (TTP) per RECIST 1.1 | Up to 3.5 Years |
| Time to Subsequent Therapy | Up to 3.5 Years |
| Overall Survival (OS) | Up to 3.5 Years |
| Maximum Serum Concentration (Cmax) of Tarlatamab | Up to Week 36 |
| Minimum Serum Concentration (Cmin) of Tarlatamab | Up to Week 36 |
| Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for Tarlatamab | Up to Week 36 |
| Half-life (t1/2) of Tarlatamab | Up to Week 36 |
Countries
Canada, China, France, Germany, Greece, Hungary, Italy, South Korea, Spain, United States
Contacts
CONTACTAmgen Call Center
STUDY_DIRECTORMD
Amgen
Outcome results
None listed