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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000131-23 | EudraCT Number | ||
| MORAb-202-G000-203 | Other Identifier | Eisai Protocol Number |
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Business objectives have changed
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| Name | Class |
|---|---|
| Eisai Inc. | INDUSTRY |
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The aim of this study is to characterize the safety and tolerability of MORAb-202, and to assess the objective response rate in participants with previously treated, metastatic NSCLC AC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MORAb-202 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MORAb-202 | Drug | Specified dose on specified days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate as Per Investigator | ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months) |
| Number of Participants With Drug -Related Adverse Events Leading to Discontinuation | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. | From first dose and 30 days after last dose of study therapy (up to approximately 12 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Serious adverse events (SAE) are defined as any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Death). |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0007 | Orange | California | 92868-3201 | United States | ||
| Local Institution - 0035 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
See Plan Description
See Plan Description
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| ID | Title | Description |
|---|---|---|
| FG000 | MORAb-202 25mg/m^2 | Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m^2 intravenous infusion once every 3 weeks (Q3W). |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2023 |
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| From first dose and 30 days after last dose of study therapy (up to approximately 12 months). |
| Disease Control Rate as Per Investigator | Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD) divided by the number of all randomized participants. per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months) |
| Duration of Response as Per Investigator | DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months) |
| Progression Free-Survival as Per Investigator | PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. | From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months) |
| Lone Tree |
| Colorado |
| 80124 |
| United States |
| Local Institution - 0043 | Clermont | Florida | 34711-6699 | United States |
| Local Institution - 0010 | Orange City | Florida | 32763-8316 | United States |
| Local Institution - 0001 | Marietta | Georgia | 30060 | United States |
| Local Institution - 0005 | Louisville | Kentucky | 40241-2832 | United States |
| Local Institution - 0044 | Silver Spring | Maryland | 20904-7917 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202-2608 | United States |
| Local Institution - 0002 | Kansas City | Missouri | 64132 | United States |
| Local Institution - 0011 | Charlotte | North Carolina | 28207 | United States |
| Local Institution - 0034 | Arlington | Texas | 76012-2510 | United States |
| Local Institution - 0045 | Flower Mound | Texas | 75028-1713 | United States |
| Local Institution - 0033 | Fairfax | Virginia | 22031-4629 | United States |
| Local Institution - 0040 | Wollongong | NS | 2500 | Australia |
| Local Institution - 0012 | Ballarat Central | Victoria | 3350 | Australia |
| Local Institution - 0022 | Murdoch | Western Australia | 6150 | Australia |
| Local Institution - 0039 | Mons | WHT | 7000 | Belgium |
| Local Institution - 0036 | Roeselare | 8800 | Belgium |
| Local Institution - 0028 | Providencia | SA | 7500653 | Chile |
| Local Institution - 0030 | Independencia | 8380456 | Chile |
| Local Institution - 0027 | Recoleta | 8420383 | Chile |
| Local Institution - 0023 | Santiago | 7500921 | Chile |
| Local Institution - 0017 | Rouen | 76000 | France |
| Local Institution - 0015 | Suresnes | 92151 | France |
| Local Institution - 0014 | Toulon | 83056 | France |
| Local Institution - 0038 | Villejuif | 94805 | France |
| Local Institution - 0020 | Málaga | MA | 29010 | Spain |
| Local Institution - 0019 | Majadahonda (Madrid) | M | 28222 | Spain |
| Local Institution - 0025 | Barcelona | 08035 | Spain |
| Local Institution - 0021 | Barcelona | 08036 | Spain |
| Local Institution - 0018 | Madrid | 28041 | Spain |
| Local Institution - 0026 | Santiago de Compostela | 15706 | Spain |
| Local Institution - 0031 | Seville | 41013 | Spain |
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MORAb-202 25mg/m^2 | Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m^2 intravenous infusion once every 3 weeks (Q3W). |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 as Per Investigator | ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | All Randomized Participants | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months) |
|
|
| |||||||||||||||||||||||||
| Primary | Number of Participants With Drug -Related Adverse Events Leading to Discontinuation | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. | All Treated Participants | Posted | Count of Participants | Participants | From first dose and 30 days after last dose of study therapy (up to approximately 12 months). |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Serious adverse events (SAE) are defined as any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Death). | All Treated Participants | Posted | Count of Participants | Participants | From first dose and 30 days after last dose of study therapy (up to approximately 12 months). |
| ||||||||||||||||||||||||||||
| Secondary | Disease Control Rate as Per Investigator | Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD) divided by the number of all randomized participants. per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | All Randomized Participants | Posted | Number | 95% Confidence Interval | percentage of participants | From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response as Per Investigator | DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | All Randomized Participants. Only responders (CR or PR) were analyzed. | Posted | Median | Full Range | months | From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months) |
|
| ||||||||||||||||||||||||||
| Secondary | Progression Free-Survival as Per Investigator | PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. | All Randomized Participants | Posted | Median | 95% Confidence Interval | months | From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months) |
|
|
All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months).
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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 | MORAb-202 25mg/m^2 | Participants with metastatic non-small cell lung cancer (NSCLC) adenocarcinoma after progression on prior therapies received 25mg/m^2 intravenous infusion once every 3 weeks (Q3W). | 7 | 31 | 7 | 31 | 29 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 27.0 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 27.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Eosinophilic pneumonia | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 27.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | 27.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | 27.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 27.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Aug 12, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000230 | Adenocarcinoma |
| 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 |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000718069 | MORAb-202 |
Not provided
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Units | Counts |
|---|---|
| Participants |
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| Counts |
|---|
| Participants |
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| Participants |
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