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

JRCT ID: jRCT2061240005

Registered date:27/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Small Cell Lung Cancer
• Date of first enrollment: 02/04/2024
• Target sample size: 158
• Countries of recruitment: Brazil,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Tarlatamab
Tarlatamab will be administered as a 60-minute intravenous infusion with 1 mg step dose on cycle 1 day 1 followed by a 10mg 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 2weeks.
Other Name: AMG 757

Outcome(s)

• Primary Outcome: Incidence of treatment-emergent adverse events (TEAEs) including grade >= 3 TEAEs, serious TEAEs, TEAEs leading to treatment discontinuation, fatal TEAEs, and treatment-related adverse events, and events of interest

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

1. 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
2. Untreated or symptomatic central nervous system (CNS) metastases
Active hepatitis B or hepatitis C virus infection
3. Eligible for participation in any Amgen-sponsored ongoing clinical study of the investigational product
4. Currently or previously enrolled in a prior tarlatamab study
5. Female participants and/or male participants with female partners who are pregnant, breastfeeding, planning to become pregnant or donate eggs while on study through 72 days after the last dose of tarlatamab
6. Male and female participants unwilling to practice abstinence and/or use protocol specified method of contraception

Related Information

• Primary Sponsor: Tagashira Shuzo
• Secondary ID(s): NCT06064500