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| Name | Class |
|---|---|
| BeOne Medicines | INDUSTRY |
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The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Dose Exploration | Experimental | Tarlatamab will be administered as a SC injection in Part 1. |
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| Part 2 Dose Expansion | Experimental | Following the selection of a SC dosing regimen in Part 1, tarlatamab will be administered in Part 2 at the dose deemed safe and tolerable in Part 1. |
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| Part 3 Alternative Dosing | Experimental | Following the selection of a SC dosing regimen from Part 1 that will be used in Part 2 dose expansion, Part 3 may open to test alternative dosing of SC tarlatamab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tarlatamab | Drug | Administered by SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Dose-limiting toxicities (DLTs) | Up to day 21 | |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Up to approximately 24 months | |
| Number of Participants with Changes in Vital Signs | Up to approximately 24 months | |
| Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration (Cmax) of Tarlatamab | Up to approximately 12 months | |
| Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab | Up to approximately 12 months | |
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Inclusion Criteria:
Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amgen Call Center | Contact | 866-572-6436 | medinfo@amgen.com |
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California, Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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.
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.
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| Time to Cmax (Tmax) of Tarlatamab |
| Up to approximately 12 months |
| Area Under the Concentration-time Curve (AUC) of Tarlatamab | Up to approximately 12 months |
| Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Up to approximately 24 months |
| Duration of Response (DOR) per RECIST 1.1 | Up to approximately 24 months |
| Time to Response (TTR) per RECIST 1.1 | Up to approximately 24 months |
| Progression-free Survival (PFS) per RECIST 1.1 | Up to approximately 24 months |
| Time to Progression per RECIST 1.1 | Up to approximately 24 months |
| Time to Subsequent Therapy | Up to approximately 24 months |
| Overall Survival (OS) | Up to approximately 24 months |
| Number of Participants with Anti-tarlatamab Antibody Formation | Up to approximately 24 months |
| University of Illinois Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
| Trinity Health Saint Joseph Mercy Ann Arbor | Recruiting | Ann Arbor | Michigan | 48106 | United States |
| Avera Cancer Institute | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Swedish Cancer Institute | Recruiting | Seattle | Washington | 98104 | United States |
| Chris OBrien Lifehouse | Recruiting | Camperdown | New South Wales | 2050 | Australia |
| Calvary Mater Newcastle Hospital | Recruiting | Waratah | New South Wales | 2298 | Australia |
| The Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
| Universitair Ziekenhuis Gent | Recruiting | Ghent | 9000 | Belgium |
| Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Recruiting | Leuven | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liege - Sart Tilman | Recruiting | Liège | 4000 | Belgium |
| Jilin Cancer Hospital | Recruiting | Changchun | Jilin | 130012 | China |
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| Universitaetsklinikum Regensburg | Recruiting | Regensburg | 93053 | Germany |
| Universitaetsklinikum Wuerzburg | Recruiting | Würzburg | 97078 | Germany |
| Okayama University Hospital | Recruiting | Okayama | Okayama-ken | 700-8558 | Japan |
| Wakayama Medical University Hospital | Recruiting | Wakayama | Wakayama | 641-8510 | Japan |
| Uniwersyteckie Centrum Kliniczne | Recruiting | Gdansk | 80-214 | Poland |
| Instytut Centrum Zdrowia Matki Polki | Recruiting | Lodz | 93-338 | Poland |
| Wojewodzki Szpital im Sw Ojca Pio w Przemyslu | Recruiting | Przemyśl | 37-700 | Poland |
| Hospital Regional Universitario de Malaga | Recruiting | Málaga | Andalusia | 29011 | Spain |
| Hospital Universitari Vall d Hebron | Recruiting | Barcelona | Catalonia | 08035 | Spain |
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | Valencia | 46026 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Kantonsspital Graubuenden | Recruiting | Chur | 7000 | Switzerland |
| Freiburg Spital | Recruiting | Fribourg | 1708 | Switzerland |
| Kantonsspital Winterthur | Recruiting | Winterthur | 8401 | Switzerland |
| Adana Sehir Egitim ve Arastirma Hastanesi | Recruiting | Adana | 01370 | Turkey (Türkiye) |
| Ankara Bilkent Sehir Hastanesi | Recruiting | Ankara | 06800 | Turkey (Türkiye) |
| Koc Universitesi Hastanesi | Recruiting | Istanbul | 34010 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000722655 | AMG 757 |
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