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Clinical Trial Finder

Search Results

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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.
  • - 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.

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.
  • - 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 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 period of time after the last dose of study drug as specified in the study protocol.
  • - Female participants who are breastfeeding or who plan to breastfeed while on study and for an additional period of time after the last dose of study drug as specified in the study protocol.
  • - Female participants planning to become pregnant or donate eggs while on study and for an additional period of time after the last dose of study drug as specified in the study protocol.
  • - 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 period of time after the last dose of study drug as specified in the study protocol.
  • - Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional period of time after the last dose of study drug as specified in the study protocol.
  • - Male participants unwilling to abstain from donating sperm during treatment and for an additional period of time after the last dose of study drug as specified in the study protocol.
  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06502977
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Extensive Stage Small Cell Lung Cancer
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Tarlatamab

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

Interventions

Drug: - Tarlatamab

IV infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing Cancer Hospital, Beijing 1816670, Beijing Municipality 2038349, China

Status

Address

Beijing Cancer Hospital

Beijing 1816670, Beijing Municipality 2038349, 100142

Chongqing 1814906, Chongqing Municipality 1814905, China

Status

Address

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

Chongqing 1814906, Chongqing Municipality 1814905, 400037

Chongqing 1814906, Chongqing Municipality 1814905, China

Status

Address

Army Special Medical Center of Peoples Liberation Army

Chongqing 1814906, Chongqing Municipality 1814905, 400042

Fuzhou 1810821, Fujian 1811017, China

Status

Address

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou 1810821, Fujian 1811017, 350025

Sun Yat-Sen University Cancer Center, Guangzhou 1809858, Guangdong 1809935, China

Status

Address

Sun Yat-Sen University Cancer Center

Guangzhou 1809858, Guangdong 1809935, 510060

Jiangmen Central Hospital, Jiangmen 1806299, Guangdong 1809935, China

Status

Address

Jiangmen Central Hospital

Jiangmen 1806299, Guangdong 1809935, 529000

Harbin 2037013, Heilongjiang 2036965, China

Status

Address

Harbin Meidical University Cancer Hospital

Harbin 2037013, Heilongjiang 2036965, 150000

Wuhan 1791247, Hubei 1806949, China

Status

Address

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan 1791247, Hubei 1806949, 430030

Tianjin 1792947, Tianjin Municipality 1792943, China

Status

Address

Tianjin Medical University General Hospital

Tianjin 1792947, Tianjin Municipality 1792943, 300052

Hangzhou 1808926, Zhejiang 1784764, China

Status

Address

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou 1808926, Zhejiang 1784764, 310009

Taizhou Hospital of Zhejiang Province, Linhai 1803422, Zhejiang 1784764, China

Status

Address

Taizhou Hospital of Zhejiang Province

Linhai 1803422, Zhejiang 1784764, 317000

Fujian Cancer Hospital, Fuzhou 1810821, China

Status

Address

Fujian Cancer Hospital

Fuzhou 1810821, , 350011

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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