A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301) - 20200491 - DeLLphi-301

Amgen0 sites3 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•o Male and female subjects (\>\= 18 years of age) at the time of signing the
•inform consent
•o Histologically or cytologically confirmed relapsed/refractory SCLC
•o Subject who progressed or recurred following 1 platinum\-based regimen and at
•least 1 other prior line of therapy
•(Note: \[1] re\-treatment with a platinum\-based regimen is considered a second
•line of therapy; \[2] platinum\-based regimen followed by checkpoint
•inhibitor/anti\-programmed death ligand 1 \[PD\-L1] as maintenance therapy is
•considered 1 line of therapy; \[3] in countries where standard of care first
•line systemic treatment includes platinum

•\- Untreated or symptomatic brain metastases and leptomeningeal disease.
•\- Has evidence of interstitial lung disease or active, non\-infectious
•pneumonitis.
•\- Subjects who experienced recurrent pneumonitis (grade 2 or higher) or severe,
•life\-threatening immune\-mediated adverse events or infusion\-related reactions
•including those that lead to permanent discontinuation while on treatment with
•immuno\-oncology agents.
•\- Unresolved toxicity from prior anti\-tumor therapy, defined as not having
•resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5\.0
•grade 1, or to levels dictated in the eligibility criteria with the exception

Not specified