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Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer

A Phase 3b, Multicenter, Single-arm, Expanded Access Protocol of Tarlatamab (AMG 757) for the Treatment of Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Status
APPROVED_FOR_MARKETING
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT06064500
Enrollment
Unknown
Registered
2023-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Cancer

Keywords

Lung cancer, Extensive-stage small cell lung cancer, Tarlatamab, AMG 757, Bispecific T-Cell Engager, BiTE, Immunotherapy, Immuno-oncology, Delta-like ligand 3

Brief summary

The primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen). EA may still be available in countries outside of the United States.

Interventions

DRUGTarlatamab

Tarlatamab will be administered as a 60-minute intravenous infusion with 1 mg step dose on cycle 1 day 1 followed by a 10 mg target dose on cycle 1 day 8 and cycle 1 day 15 in a 28-day cycle. Subsequent doses (10 mg) will be administered every 2 weeks.

Sponsors

Amgen
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Age ≥ 18 years * Histologically or cytologically confirmed SCLC * Extensive-stage, unable to be encompassed in a tolerable radiation plan * Progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy * Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1 * Minimum life expectancy of 12 weeks

Exclusion criteria

* Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology * Symptomatic central nervous system (CNS) metastases * Active hepatitis B or hepatitis C virus infection * Eligible for participation in any Amgen-sponsored ongoing clinical study of the investigational product * Currently or previously enrolled in a prior tarlatamab study * Female participants and/or male participants with female partners who are pregnant, breastfeeding, planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab * Male and female participants unwilling to practice abstinence and/or use protocol specified method of contraception

Countries

Brazil, Israel, Japan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026