A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 757 in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Amgen Inc.0 sites160 target enrollmentOctober 18, 2021

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 18, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Amgen Inc.

Eligibility Criteria

Inclusion Criteria

•101 Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
•102 Male and female subjects \>\= 18 years of age (or legal adult age within country) at the time of signing the informed consent.
•103 Histologically or cytologically confirmed relapsed/refractory SCLC
•104 Subjects 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 containing chemotherapy in combination with PD\-L1 inhibitor, it is required that patients to have failed PD\-L1 inhibitor as part of their first line systemic treatment or not have access to.
•105 Subjects willing to provide archived tumor tissue samples (formalin fixed, paraffin embedded \[FFPE] sample) or willing to undergo pretreatment tumor biopsy. Subjects who do not have archived tumor tissue available and are unable to undergo a pretreatment tumor biopsy due to extenuating circumstances (eg, cannot be performed safely or inaccessible, as determined by the investigator) may be allowed to enroll without a tumor biopsy upon agreement between the investigator and Amgen medical monitor.
•106 Eastern Cooperative Oncology Group (ECOG) performance status of 0\-1\.
•107 Minimum life expectancy of 12 weeks.
•108 Measurable lesions as defined per RECIST 1\.1 within 21 days prior to the first
•dose of AMG 757\.

Exclusion Criteria

•Disease Related
•201 Untreated or symptomatic brain metastases and leptomeningeal disease.
•202 Has evidence of interstitial lung disease or active, non\-infectious pneumonitis.
•203 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.
•204 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 of alopecia or toxicities from prior anti\-tumor therapy that are considered irreversible(defined as having been present and stable for \> 21 day) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and Amgen.
•Other Medical Conditions
•205 History of other malignancy within the past 2 years, with the following exceptions:
•\- malignancy treated with curative intent and with no known active disease
•present for \>\= 2 years before enrollment and felt to be at low risk for recurrence by the treating physician.
•\- adequately treated non\-melanoma skin cancer or lentigo maligna without evidence of disease.