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

NCT06502977 | Active Not Recruiting Phase 2 Results FDA Drug

• 1 other identifier: 20230273
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 12

Brief 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).

Conditions

Extensive Stage Small Cell Lung Cancer

Keywords

Extensive Stage Small Cell Lung Cancer; 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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  ORR based on BICR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) plus partial response (PR). CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to \<10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 is presented.

  From first dose of trial drug up to a minimum of last dose + 65 days or data cutoff date; median (min, max) time on trial was 3.4 (2.2, 6.5) months at data cut off

Secondary Outcomes (13)

• Duration of Response (DOR) Based on BICR Per RECIST 1.1

  Approximately 24 months

• Disease Control (DC) Based on BICR Per RECIST 1.1

  Approximately 24 months

• Duration of DC Based on BICR Per RECIST 1.1

  Approximately 24 months

• Progression-free Survival (PFS) Based on BICR Per RECIST 1.1

  Approximately 24 months

• ORR Based on Investigator Assessment Per RECIST 1.1

  Approximately 24 months

Study Arms (1)

Tarlatamab

EXPERIMENTAL

Participants will receive tarlatamab as an intravenous (IV) infusions in 28-day cycles.

Drug: Tarlatamab

Interventions

Tarlatamab DRUG

IV infusion

Also known as: AMG 757, IMDELLTRA™

Tarlatamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Extensive-stage SCLC 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (12)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

The Second Affiliated Hospital of Army Medical University, People's Liberation Army

Chongqing, Chongqing Municipality, 400037, China

Location

Army Special Medical Center of Peoples Liberation Army

Chongqing, Chongqing Municipality, 400042, China

Location

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 350025, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Jiangmen Central Hospital

Jiangmen, Guangdong, 529000, China

Location

Harbin Meidical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, 317000, China

Location

Fujian Cancer Hospital

Fuzhou, 350011, China

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Neoplasms; Neuroendocrine Tumors

Interventions

AMG 757

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: August 27, 2024
• Primary Completion: March 28, 2025
• Study Completion (Estimated): January 8, 2027
• Last Updated: April 15, 2026
• Results First Posted: April 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

CN (12)