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

Last updated: April 14, 2025
Sponsor: Amgen
Overall Status: Active - Not Recruiting

Phase

2

Condition

Small Cell Lung Cancer

Treatment

Tarlatamab

Clinical Study ID

NCT06502977
20230273
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant has provided informed consent prior to initiation of any study specificactivities/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 1platinum-based regimen as 1L therapy (including a PD-1/PD-[L]1) and at least 1 otherprior line of therapy.

  • Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first doseof study drug.

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

  • Minimum life expectancy of 12 weeks.

  • Adequate organ function.

Exclusion

Exclusion Criteria:

Disease Related

  • Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermalgrowth factor receptor (EGFR) activating mutation positive NSCLC that hastransformed 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 replacementtherapy) within the past 2 years or any other diseases requiring immunosuppressivetherapy 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 HeartAssociation > class II) within 12 months of first dose of study drug.

  • History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12months of first dose of study drug.

  • Participants with symptoms and/or clinical signs and/or radiographic signs thatindicate an acute and/or uncontrolled active systemic infection within 7 days priorto 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

  • Currently or previously enrolled in a tarlatamab study.

  • 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 therapywithin 7 days prior to the first dose of study drug, with certain exceptions.

  • Treatment with live virus, including live-attenuated vaccination, within 14 daysprior to the first dose of study drug. Inactive vaccines (eg, non-live ornon-replicating agent) and live viral non-replicating vaccines (eg, Jynneos for mpoxinfection) 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-specifiedmethod of contraception during treatment and for an additional period of time afterthe last dose of study drug as specified in the study protocol.

  • Female participants who are breastfeeding or who plan to breastfeed while on studyand for an additional period of time after the last dose of study drug as specifiedin the study protocol.

  • Female participants planning to become pregnant or donate eggs while on study andfor an additional period of time after the last dose of study drug as specified inthe study protocol.

  • Female participants of childbearing potential with a positive pregnancy testassessed at screening by a highly sensitive serum pregnancy test.

  • Male participants with a female partner of childbearing potential who are unwillingto practice sexual abstinence (refrain from heterosexual intercourse) or usecontraception during treatment and for an additional period of time after the lastdose of study drug as specified in the study protocol.

  • Male participants with a pregnant partner who are unwilling to practice abstinenceor use a condom during treatment and for an additional period of time after the lastdose of study drug as specified in the study protocol.

  • Male participants unwilling to abstain from donating sperm during treatment and foran additional period of time after the last dose of study drug as specified in thestudy protocol.

  • Participants has known sensitivity to any of the products or components to beadministered during dosing.

  • Participants likely to not be available to complete all protocol-required studyvisits or procedures, and/or to comply with all required study procedures.

  • History or evidence of any other clinically significant disorder, condition, ordisease 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.

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: Tarlatamab
Phase: 2
Study Start date:
August 27, 2024
Estimated Completion Date:
May 11, 2026

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Army Special Medical Center of Peoples Liberation Army

    Chongqing, Chongqing 400042
    China

    Site Not Available

  • The Second Affiliated Hospital of Army Medical University, PLA

    Chongqing, Chongqing 400037
    China

    Active - Recruiting

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

    Chongqing, Chongqing 400037
    China

    Site Not Available

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian 350025
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fujian, Fuzhou 350011
    China

    Active - Recruiting

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fujian, Fuzhou 350025
    China

    Site Not Available

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Jiangmen Central Hospital

    Jiangmen, Guangdong 529000
    China

    Site Not Available

  • Harbin Meidical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Jiangmen Central Hospital

    Guangdong, Jiangmen 529030
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Zhejiang, Taizhou 317000
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Hubei, Wuhan 430032
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Linhai, Zhejiang 317000
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, 350011
    China

    Site Not Available

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