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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tarlatamab | Experimental | Participants will receive tarlatamab as an intravenous (IV) infusions in 28-day cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tarlatamab | Drug | IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | ORR based on BICR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) plus partial response (PR). CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 is presented. | From first dose of trial drug up to a minimum of last dose + 65 days or data cutoff date; median (min, max) time on trial was 3.4 (2.2, 6.5) months at data cut off |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) Based on BICR Per RECIST 1.1 | DOR was defined as time from the first documentation of OR until the first documentation of disease progression (PD) or death due to any cause, whichever occured first. Only participants who had achieved OR were evaluated for DOR. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have reduction in short axis to <10 mm, NOT total disappearance. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that is the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD. |
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Inclusion Criteria:
Exclusion Criteria:
Disease Related
Other Medical Conditions
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
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| The Second Affiliated Hospital of Army Medical University, People's Liberation Army |
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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.
Chinese participants with advanced small cell lung cancer (SCLC) who had progressed on or recurred following 1 platinum-based regimen as 1L therapy (including a programmed cell death 1 [PD-1]/programmed death ligand 1 [PD-L1]) and at least 1 other prior line of therapy received tarlatamab.
Participants were enrolled at 12 trial centers in China from 27 August 2024. The trial is ongoing, he primary analysis data is presented based on the database snapshot date of 30 April 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tarlatamab | Participants received tarlatamab as an intravenous (IV) infusion with 1-step dosing: 1 mg on Cycle 1 Day 1 followed by the target dose of 10 mg on Cycle 1 Days 8 and 15, and every 2 weeks (Q2W) thereafter. Each cycle was 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 6, 2024 | Mar 27, 2026 |
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| Approximately 24 months |
| Disease Control (DC) Based on BICR Per RECIST 1.1 | DC was defined as CR + PR + stable disease (SD). CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that is the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrate an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD. | Approximately 24 months |
| Duration of DC Based on BICR Per RECIST 1.1 | Duration of DC was defined as time from first documentation of CR,PR, or SD until first documentation of disease progression or death due to any cause, whichever occurred first. Only participants who had achieved CR,PR, or SD would be evaluated for Duration of DC. CR:Disappearance of all target non-nodal lesions.Any target lymph node must have reduction in short axis to <10 mm,NOT total disappearance.PR:At least a 30% decrease in sum of diameters of target lesions, taken as reference baseline sum of diameters. SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD:At least 20% increase in sum of diameters of target lesions, taken as reference smallest sum on trial.In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm.If participant was missing lesion data at disease assessment and yet progressive disease criteria was met despite missing data, participant would be classified as having PD. | Approximately 24 months |
| Progression-free Survival (PFS) Based on BICR Per RECIST 1.1 | PFS was defined as the time from first dose of tarlatamab until PD or death from any cause, whichever occurred first. At least a 20% increase in the sum of the diameters of target lesions, taken as reference the smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD. | Approximately 24 months |
| ORR Based on Investigator Assessment Per RECIST 1.1 | ORR based on investigator assessment was defined as the percentage of participants with BOR of CR plus PR. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. | Approximately 24 months |
| DOR Based on Investigator Assessment Per RECIST 1.1 | DOR was defined as time from the first documentation of OR until the first documentation of PD or death due to any cause, whichever occurred first. Only participants who had achieved OR would be evaluated for DOR. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD. | Approximately 24 months |
| DC Based on Investigator Assessment Per RECIST 1.1 | DC was defined as CR + PR + SD. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD. | Approximately 24 months |
| Duration of DC Based on Investigator Assessment Per RECIST 1.1 | Duration of DC was defined as time from first documentation of CR,PR, or SD until first documentation of disease progression or death due to any cause, whichever occurred first. Only participants who had achieved CR,PR, or SD would be evaluated for Duration of DC. CR:Disappearance of all target non-nodal lesions.Any target lymph node must have reduction in short axis to <10 mm,NOT total disappearance.PR:At least a 30% decrease in sum of diameters of target lesions, taken as reference baseline sum of diameters. SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD:At least 20% increase in sum of diameters of target lesions, taken as reference smallest sum on trial.In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm.If participant was missing lesion data at disease assessment and yet progressive disease criteria was met despite missing data, participant would be classified as having PD. | Approximately24 months |
| PFS Based on Investigator Assessment Per RECIST 1.1 | PFS was defined as time from enrollment until PD or death from any cause, whichever occurred first. At least a 20% increase in the sum of the diameters of target lesions, taken as reference the smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD. | Approximately 24 months |
| Overall Survival (OS) | OS was defined as time from the first dose of tarlatamab until death from any cause. | Approximately 24 months |
| Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment. TEAEs were defined as AEs starting on or after the first dose of tarlatamab up to the safety follow-up (SFU) visit or 60 days after the last dose of tarlatamab, whichever was later. | Approximately 24 months |
| Trough Concentration (Ctrough) of Tarlatamab | Ctrough of tarlatamab was calculated using standard noncompartmental methods. | Approximately 24 months |
| Number of Participants With Anti-tarlatamab Antibodies Formation | Number of participants with anti-tarlatamab (binding and neutralizing) antibodies was presented. | Approximately 24 months |
| Chongqing |
| Chongqing Municipality |
| 400037 |
| China |
| Army Special Medical Center of Peoples Liberation Army | Chongqing | Chongqing Municipality | 400042 | China |
| Mengchao Hepatobiliary Hospital of Fujian Medical University | Fuzhou | Fujian | 350025 | China |
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| Jiangmen Central Hospital | Jiangmen | Guangdong | 529000 | China |
| Harbin Meidical University Cancer Hospital | Harbin | Heilongjiang | 150000 | China |
| Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| Taizhou Hospital of Zhejiang Province | Linhai | Zhejiang | 317000 | China |
| Fujian Cancer Hospital | Fuzhou | 350011 | China |
| Participants Who Received Tarlatamab |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety analysis set consisted of all participants who received at least 1 dose of tarlatamab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tarlatamab | Participants received tarlatamab as an intravenous infusion with 1-step dosing: 1 mg on Cycle 1 Day 1 followed by the target dose of 10 mg on Cycle 1 Days 8 and 15, and Q2W thereafter. Each cycle was 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | ORR based on BICR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) plus partial response (PR). CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 is presented. | The safety analysis set consisted of all participants who received at least 1 dose of tarlatamab. | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose of trial drug up to a minimum of last dose + 65 days or data cutoff date; median (min, max) time on trial was 3.4 (2.2, 6.5) months at data cut off |
|
|
| |||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Based on BICR Per RECIST 1.1 | DOR was defined as time from the first documentation of OR until the first documentation of disease progression (PD) or death due to any cause, whichever occured first. Only participants who had achieved OR were evaluated for DOR. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have reduction in short axis to <10 mm, NOT total disappearance. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that is the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD. | Not Posted | Jan 2028 | Approximately 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Disease Control (DC) Based on BICR Per RECIST 1.1 | DC was defined as CR + PR + stable disease (SD). CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that is the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrate an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD. | Not Posted | Jan 2028 | Approximately 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Duration of DC Based on BICR Per RECIST 1.1 | Duration of DC was defined as time from first documentation of CR,PR, or SD until first documentation of disease progression or death due to any cause, whichever occurred first. Only participants who had achieved CR,PR, or SD would be evaluated for Duration of DC. CR:Disappearance of all target non-nodal lesions.Any target lymph node must have reduction in short axis to <10 mm,NOT total disappearance.PR:At least a 30% decrease in sum of diameters of target lesions, taken as reference baseline sum of diameters. SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD:At least 20% increase in sum of diameters of target lesions, taken as reference smallest sum on trial.In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm.If participant was missing lesion data at disease assessment and yet progressive disease criteria was met despite missing data, participant would be classified as having PD. | Not Posted | Jan 2028 | Approximately 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Based on BICR Per RECIST 1.1 | PFS was defined as the time from first dose of tarlatamab until PD or death from any cause, whichever occurred first. At least a 20% increase in the sum of the diameters of target lesions, taken as reference the smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD. | Not Posted | Jan 2028 | Approximately 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | ORR Based on Investigator Assessment Per RECIST 1.1 | ORR based on investigator assessment was defined as the percentage of participants with BOR of CR plus PR. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. | Not Posted | Jan 2028 | Approximately 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | DOR Based on Investigator Assessment Per RECIST 1.1 | DOR was defined as time from the first documentation of OR until the first documentation of PD or death due to any cause, whichever occurred first. Only participants who had achieved OR would be evaluated for DOR. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD. | Not Posted | Jan 2028 | Approximately 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | DC Based on Investigator Assessment Per RECIST 1.1 | DC was defined as CR + PR + SD. CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to <10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: At least 20% increase in the sum of the diameters of target lesions, taken as reference smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD. | Not Posted | Jan 2028 | Approximately 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Duration of DC Based on Investigator Assessment Per RECIST 1.1 | Duration of DC was defined as time from first documentation of CR,PR, or SD until first documentation of disease progression or death due to any cause, whichever occurred first. Only participants who had achieved CR,PR, or SD would be evaluated for Duration of DC. CR:Disappearance of all target non-nodal lesions.Any target lymph node must have reduction in short axis to <10 mm,NOT total disappearance.PR:At least a 30% decrease in sum of diameters of target lesions, taken as reference baseline sum of diameters. SD:Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD:At least 20% increase in sum of diameters of target lesions, taken as reference smallest sum on trial.In addition to relative increase of 20%, sum must have also demonstrated an absolute increase of at least 5 mm.If participant was missing lesion data at disease assessment and yet progressive disease criteria was met despite missing data, participant would be classified as having PD. | Not Posted | Jan 2028 | Approximately24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | PFS Based on Investigator Assessment Per RECIST 1.1 | PFS was defined as time from enrollment until PD or death from any cause, whichever occurred first. At least a 20% increase in the sum of the diameters of target lesions, taken as reference the smallest sum on trial (this included the baseline sum if that was the smallest on trial). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. If a participant was missing lesion data at a disease assessment and yet progressive disease criteria was met despite the missing data, the participant would be classified as having PD. | Not Posted | Jan 2028 | Approximately 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as time from the first dose of tarlatamab until death from any cause. | Not Posted | Jan 2028 | Approximately 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) | An AE was any untoward medical occurrence in a clinical trial participant irrespective of a causal relationship with the trial treatment. TEAEs were defined as AEs starting on or after the first dose of tarlatamab up to the safety follow-up (SFU) visit or 60 days after the last dose of tarlatamab, whichever was later. | Not Posted | Jan 2028 | Approximately 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Trough Concentration (Ctrough) of Tarlatamab | Ctrough of tarlatamab was calculated using standard noncompartmental methods. | Not Posted | Jan 2028 | Approximately 24 months | Participants | ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-tarlatamab Antibodies Formation | Number of participants with anti-tarlatamab (binding and neutralizing) antibodies was presented. | Not Posted | Jan 2028 | Approximately 24 months | Participants |
For all-cause mortality, from enrollment until death or data cut-off: Median (min, max) was 3.8 (0.7, 7.0) months; AEs were collected from first dose of tarlatamab until last dose + 65 days or data cut-off: Median (min, max) duration was 3.4 (2.2, 6.5) months
All-cause mortality was reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tarlatamab | Participants received tarlatamab as an intravenous infusion with 1-step dosing: 1 mg on Cycle 1 Day 1 followed by the target dose of 10 mg on Cycle 1 Days 8 and 15, and Q2W thereafter. Each cycle was 28 days. | 3 | 32 | 7 | 31 | 31 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated hypothyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Alpha hydroxybutyrate dehydrogenase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Bile acids increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Blood fibrinogen increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Blood urea increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary occult blood positive | Investigations | MedDRA 27.1 | Systematic Assessment |
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| Urobilinogen urine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypergeusia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Intercostal neuralgia | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Prostatic calcification | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2025 | Mar 27, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722655 | AMG 757 |
Not provided
Not provided
Not provided