Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06064500 |
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Expanded Access Status :
Available
First Posted : October 3, 2023
Last Update Posted : May 1, 2024
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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| Tracking Information | |||||
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| First Submitted Date | September 26, 2023 | ||||
| First Posted Date | October 3, 2023 | ||||
| Last Update Posted Date | May 1, 2024 | ||||
| Descriptive Information | |||||
| Brief Title | Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer | ||||
| Brief Summary | The primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen). | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Expanded Access | ||||
| Expanded Access Type | Treatment IND/Protocol | ||||
| Intervention | Drug: Tarlatamab
Tarlatamab will be administered as a 60-minute intravenous infusion with 1 mg step dose on cycle 1 day 1 followed by a 10 mg target dose on cycle 1 day 8 and cycle 1 day 15 in a 28-day cycle. Subsequent doses (10 mg) will be administered every 2 weeks.
Other Name: AMG 757
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Expanded Access Status | Available | ||||
| Contacts |
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| Listed Location Countries | Brazil, Japan, United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT06064500 | ||||
| Current Responsible Party | Amgen | ||||
| Original Responsible Party | Same as current | ||||
| Current Study Sponsor | Amgen | ||||
| Original Study Sponsor | Same as current | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Amgen | ||||
| Verification Date | April 2024 | ||||