Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Trial Title: Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

NCT ID: NCT06502977

Condition: Advanced Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
AMG 757

Conditions: Keywords:
Advanced Small Cell Lung Cancer
SCLC
AMG 757
Tarlatamab
IMDELLTRA
Tumor
Programmed Cell Death Protein 1
Programmed Cell Death Ligand 1
PD-1 Protein
PD-L1 Protein
Pharmacokinetics
Malignancy
Cancer
Chinese Participants
China
Platinum
Platinum-based
Neuroendocrine tumor
Bi-specific T-cell engager
BiTE molecule

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Tarlatamab
Description: IV infusion
Arm group label: Tarlatamab

Other name: AMG 757

Other name: IMDELLTRA™

Summary: The primary aim of this study is to evaluate the efficacy of tarlatamab as assessed by objective response rate (ORR) based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Participant has provided informed consent prior to initiation of any study specific activities/procedures. - Participant must be a resident in China, and of Chinese ancestry ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent. - Histologically or cytologically confirmed small cell lung cancer. - Participants who progressed on or recurred following 1 platinum-based regimen as 1L therapy (including a PD-1/PD-[L]1) and at least 1 other prior line of therapy. - Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of study drug. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. - Minimum life expectancy of 12 weeks. - Adequate organ function. Exclusion Criteria: Disease Related - 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. - Symptomatic central nervous system (CNS) metastases. - Diagnosis or evidence of leptomeningeal disease. - Prior history of severe or life-threatening events from any immune-mediated therapy. Other Medical Conditions - Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. - History of solid organ transplantation. - Evidence of interstitial lung disease or active, non-infectious pneumonitis. - History of other malignancy within the past 2 years, with certain exceptions - Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of study drug. - History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of study drug. - Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study drug. - HIV, Hepatitis B, and Hepatitis C, with certain exceptions. - Major surgery within 28 days of first dose study drug. Prior/Concomitant Therapy - Prior therapy with tarlatamab. - Prior therapy with any selective inhibitor of the DLL3 pathway. - Prior anti-cancer therapy within 21 days prior to first dose of study treatment, with certain exceptions. - Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug, with certain exceptions. - Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study drug. Inactive vaccines (eg, non-live or non-replicating agent) and live viral non-replicating vaccines (eg, Jynneos for mpox infection) within 3 days prior to first dose of study drug. Prior/Concurrent Clinical Study Experience • Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded. Other Exclusions - Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional 86 days after the last dose of study drug. - Female participants who are breastfeeding or who plan to breastfeed while on study through 86 days after the last dose of study drug. - Female participants planning to become pregnant or donate eggs while on study through 86 days after the last dose of study drug. - Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test. - Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 146 days after the last dose of study drug. - Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 146 days after the last dose of study drug. - Male participants unwilling to abstain from donating sperm during treatment and for an additional 146 days after the last dose of study drug. - Participants has known sensitivity to any of the products or components to be administered during dosing. - Participants likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures. - History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or medical monitor if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Beijing Cancer Hospital

Address:
City: Beijing
Zip: 100142
Country: China

Status: Recruiting

Facility:
Name: The Second Affiliated Hospital of Army Medical University, PLA

Address:
City: Chongqing
Zip: 400037
Country: China

Status: Recruiting

Facility:
Name: Army Special Medical Center of Peoples Liberation Army

Address:
City: Chongqing
Zip: 400042
Country: China

Status: Recruiting

Facility:
Name: Mengchao Hepatobiliary Hospital of Fujian Medical University

Address:
City: Fuzhou
Zip: 350025
Country: China

Status: Recruiting

Facility:
Name: Sun Yat-Sen University Cancer Center

Address:
City: Guangzhou
Zip: 510060
Country: China

Status: Recruiting

Facility:
Name: Jiangmen Central Hospital

Address:
City: Jiangmen
Zip: 529000
Country: China

Status: Recruiting

Facility:
Name: Harbin Meidical University Cancer Hospital

Address:
City: Harbin
Zip: 150000
Country: China

Status: Recruiting

Facility:
Name: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Address:
City: Wuhan
Zip: 430030
Country: China

Status: Recruiting

Facility:
Name: Tianjin Medical University General Hospital

Address:
City: Tianjin
Zip: 300052
Country: China

Status: Recruiting

Facility:
Name: The Second Affiliated Hospital of Zhejiang University School of Medicine

Address:
City: Hangzhou
Zip: 310009
Country: China

Status: Recruiting

Facility:
Name: Taizhou Hospital of Zhejiang Province

Address:
City: Linhai
Zip: 317000
Country: China

Status: Recruiting

Facility:
Name: Fujian Cancer Hospital

Address:
City: Fuzhou
Zip: 350011
Country: China

Status: Recruiting

Start date: August 27, 2024

Completion date: July 2, 2026

Lead sponsor:
Agency: Amgen
Agency class: Industry

Source: Amgen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06502977
http://www.amgentrials.com