Clinical Trials List
Protocol Number20210004
NCT Number(ClinicalTrials.gov Identfier)NCT05740566
Active
2023-03-01 - 2029-05-01
Phase III
Recruiting5
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A Randomized, Open-label, Phase 3 Study of Tarlatamab Compared With Standard of Care in Subjects With Relapsed Small Cell Lung Cancer After Platinum-based First-line Chemotherapy
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chih-Jen Yang Division of Thoracic Medicine
- KUAN-LI WU Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- 郭家佑 Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
- 李玫萱 Division of Thoracic Medicine
- 莊政皓 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- JENG-SEN TSENG Division of Thoracic Medicine
- KUO-HSUAN HSU Division of Thoracic Medicine
- 李柏昕 Division of Thoracic Medicine
- YEN-HSIANG HUANG Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chong-Jen Yu Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
- Chia-Chi Lin Division of Hematology & Oncology
- 陳冠宇 Division of General Internal Medicine
- 吳尚俊 Division of General Internal Medicine
- James Chih-Hsin Yang Division of Hematology & Oncology
- 徐偉勛 Division of Hematology & Oncology
- 廖唯昱 Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- 錢穎群 Division of General Internal Medicine
- 廖斌志 Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 蔡子修 Division of General Internal Medicine
- 黃俊凱 Division of General Internal Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hsu-ching Huang Division of Thoracic Medicine
- 趙恒勝 Division of Thoracic Medicine
- 蕭慈慧 Division of Thoracic Medicine
- Chia-I Shen Division of Thoracic Medicine
- Yuh-Min Chen Division of Thoracic Medicine
- Yung-Hung Luo Division of Thoracic Medicine
- YEN-HAN TSENG Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chian-Wei Chen Division of General Internal Medicine
- 蔡政軒 Division of General Internal Medicine
- Shang-Yin Wu Division of Hematology & Oncology
- Seu-Chun Yang Division of General Internal Medicine
- Wu-Chou Su Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
- Chin-Wei Kuo Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Small Cell Lung Cancer (SCLC)
Objectives
This trial was conducted to learn more about tarlatamab compared with standard of care (SOC) chemotherapy in patients with the same condition. The purpose of this trial is to study the efficacy of the experimental treatment (tarlatamab/standard chemotherapy) and whether it causes any side effects.
Test Drug
tarlatamab (AMG 757)
Active Ingredient
tarlatamab (AMG 757)
Dosage Form
Powder for solution for infusion
Dosage
1 mg
10 mg
10 mg
Endpoints
‧ OS is defined as the time from random assignment until death from any cause.
‧ Subjects with small cell lung cancer who relapsed after first-line chemotherapy with platinum-based drugs
‧ OS
‧ Hazard Ratio (HR)
‧ Start a new anti-cancer therapy
OS will be estimated regardless of initiation of subsequent anticancer therapy (Treatment Policy Strategy).
‧ HR for OS between tarlatamab and SOC in subjects with small cell lung cancer who relapsed after first-line platinum-based chemotherapy, regardless of initiation of subsequent anticancer therapy (Therapeutic Policy Strategy).
‧ Subjects with small cell lung cancer who relapsed after first-line chemotherapy with platinum-based drugs
‧ OS
‧ Hazard Ratio (HR)
‧ Start a new anti-cancer therapy
OS will be estimated regardless of initiation of subsequent anticancer therapy (Treatment Policy Strategy).
‧ HR for OS between tarlatamab and SOC in subjects with small cell lung cancer who relapsed after first-line platinum-based chemotherapy, regardless of initiation of subsequent anticancer therapy (Therapeutic Policy Strategy).
Inclution Criteria
Inclusion Criteria:
Participant has provided informed consent prior to initiation of any study specific activities/procedures.
Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
Participants who progressed or recurred following 1 platinum-based regimen.
Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
Minimum life expectancy of 12 weeks.
Adequate organ function.
Participant has provided informed consent prior to initiation of any study specific activities/procedures.
Age ≥ 18 years (or legal adult age within country, whichever is older) at the time of signing the informed consent.
Histologically or cytologically confirmed SCLC with demonstrated progression or relapse.
Participants who progressed or recurred following 1 platinum-based regimen.
Measurable disease as defined per RECIST 1.1 within the 21-day screening period.
Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1.
Minimum life expectancy of 12 weeks.
Adequate organ function.
Exclusion Criteria
Exclusion Criteria:
Disease Related
Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
Diagnosis or evidence of leptomeningeal disease.
Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.
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.
History of solid organ transplantation.
History of other malignancy within the past 2 years, with exceptions defined in the protocol.
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to first dose of study treatment.
History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.
Presence or history of viral infection based on criteria per protocol.
Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.
Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
Evidence of interstitial lung disease or active, non-infectious pneumonitis.
Prior/Concomitant Therapy
Prior therapy with tarlatamab or any of the standard of care chemotherapy included as part of this trial or participation in any tarlatamab or any other DLL3 targeted agent clinical trial.
Prior therapy with any selective inhibitor of the DLL3 pathway.
Participant received more than one prior systemic therapy regimen for SCLC.
Prior anti-cancer therapy within 21 days prior to first dose of study treatment with exceptions defined in protocol.
Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
Use of herbal or prescription/non-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.
Use of herbal or prescription/non-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior to the first dose of study treatment.
Use of herbal or prescription/non-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.
Participants who have reached the limit dose of prior treatment with cardiotoxic drugs.
Major surgical procedures within 28 days prior to first dose of study treatment.
Live and live-attenuated vaccines within 14 days prior to the start of study treatment.
Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.
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.
Diagnostic Assessments
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, with exceptions defined in the protocol.
Other Exclusions
Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 72 days after the last dose of tarlatamab.
Female participants who are breastfeeding or who plan to breastfeed while on study through 72 days after the last dose of tarlatamab.
Female participants planning to become pregnant or donate eggs while on study through 72 days after the last dose of tarlatamab.
Female participants of childbearing potential with a positive pregnancy test assessed at screening by a 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 132 days after the last dose of tarlatamab.
Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 132 days after the last dose of tarlatamab.
Male participants unwilling to abstain from donating sperm during treatment and for an additional 132 days after the last dose of tarlatamab.
Contraception requirements for male and female participants receiving SOC therapies are based on regional prescribing information.
Breastfeeding restrictions for female participants receiving SOC therapies are based on regional prescribing information.
Participant has known sensitivity or is contraindicated to any of the products or components to be administered during dosing.
Participant 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 determined by the investigator or Amgen physician that would pose a risk to the subject safety or interfere with the study evaluation.
Disease Related
Symptomatic central nervous system (CNS) metastases with exceptions defined in the protocol.
Diagnosis or evidence of leptomeningeal disease.
Prior history of immune checkpoint inhibitors resulting in events defined in the protocol.
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.
History of solid organ transplantation.
History of other malignancy within the past 2 years, with exceptions defined in the protocol.
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months prior to first dose of study treatment.
History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months prior to first dose of study treatment.
Presence or history of viral infection based on criteria per protocol.
Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.
Symptoms and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection requiring antibiotics within 7 days prior to the first dose study treatment.
Evidence of interstitial lung disease or active, non-infectious pneumonitis.
Prior/Concomitant Therapy
Prior therapy with tarlatamab or any of the standard of care chemotherapy included as part of this trial or participation in any tarlatamab or any other DLL3 targeted agent clinical trial.
Prior therapy with any selective inhibitor of the DLL3 pathway.
Participant received more than one prior systemic therapy regimen for SCLC.
Prior anti-cancer therapy within 21 days prior to first dose of study treatment with exceptions defined in protocol.
Current anti-cancer therapy such as chemotherapy, immunotherapy, or targeted therapy with exceptions.
Use of herbal or prescription/non-prescription medications known to inhibit membrane transporters P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) within 7 days prior to the first dose of study treatment.
Use of herbal or prescription/non-prescription medications known to be moderate or strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 days prior to the first dose of study treatment.
Use of herbal or prescription/non-prescription medications known to be moderate or strong inducers of CYP3A enzymes within 28 days prior to first dose of study treatment.
Participants who have reached the limit dose of prior treatment with cardiotoxic drugs.
Major surgical procedures within 28 days prior to first dose of study treatment.
Live and live-attenuated vaccines within 14 days prior to the start of study treatment.
Inactive vaccines and live viral non-replicating vaccines within 3 days prior to the first dose of study treatment.
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.
Diagnostic Assessments
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, with exceptions defined in the protocol.
Other Exclusions
Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 72 days after the last dose of tarlatamab.
Female participants who are breastfeeding or who plan to breastfeed while on study through 72 days after the last dose of tarlatamab.
Female participants planning to become pregnant or donate eggs while on study through 72 days after the last dose of tarlatamab.
Female participants of childbearing potential with a positive pregnancy test assessed at screening by a 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 132 days after the last dose of tarlatamab.
Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 132 days after the last dose of tarlatamab.
Male participants unwilling to abstain from donating sperm during treatment and for an additional 132 days after the last dose of tarlatamab.
Contraception requirements for male and female participants receiving SOC therapies are based on regional prescribing information.
Breastfeeding restrictions for female participants receiving SOC therapies are based on regional prescribing information.
Participant has known sensitivity or is contraindicated to any of the products or components to be administered during dosing.
Participant 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 determined by the investigator or Amgen physician that would pose a risk to the subject safety or interfere with the study evaluation.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
490 participants
