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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004781-94 | EudraCT Number | ||
| JapicCTI-183916 | Registry Identifier | JAPIC |
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Last participant transitioned to alternative study.
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| Name | Class |
|---|---|
| Daiichi Sankyo Co., Ltd. | INDUSTRY |
| AstraZeneca | INDUSTRY |
Not provided
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The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: HER2 Overexpressing | Experimental | Participants with HER2-overexpressing(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). |
|
| Cohort 1a: HER2 Overexpressing | Experimental | Participants with HER2-overexpressing (immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). |
|
| Cohort 2: HER2 Mutated | Experimental | Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab deruxtecan | Drug | Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) | The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported. | From screening, up to 36 months (data cut-off) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) | The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on investigator assessment is reported. |
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Inclusion Criteria:
Exclusion Criteria:
Had been previously treated with HER2-targeted therapies, except for pan-HER class tyrosine kinase inhibitors
For Cohort 1 and Cohort 1a: Has known HER2 mutation
Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out due to imaging at screening
Has a QT interval corrected by Fridericia's formula (QTcF) prolongation to > 450 millisecond (ms) in males and > 470 ms in females
Has a medical history of clinically significant lung disease
Is suspected to have certain other protocol-defined diseases based on imaging at screening period
Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
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| Name | Affiliation | Role |
|---|---|---|
| Global Team Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego (UCSD) | La Jolla | California | 92093 | United States | ||
| University of Colorado Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39012221 | Derived | Smit EF. Trastuzumab deruxtecan in HER2-mutant non-small-cell lung cancer: a plain language summary of the DESTINY-Lung01 study. Future Oncol. 2024;20(27):1961-1971. doi: 10.1080/14796694.2024.2355724. Epub 2024 Jul 16. | |
| 38547891 | Derived | Smit EF, Felip E, Uprety D, Nagasaka M, Nakagawa K, Paz-Ares Rodriguez L, Pacheco JM, Li BT, Planchard D, Baik C, Goto Y, Murakami H, Saltos A, Pereira K, Taguchi A, Cheng Y, Yan Q, Feng W, Tsuchihashi Z, Janne PA. Trastuzumab deruxtecan in patients with metastatic non-small-cell lung cancer (DESTINY-Lung01): primary results of the HER2-overexpressing cohorts from a single-arm, phase 2 trial. Lancet Oncol. 2024 Apr;25(4):439-454. doi: 10.1016/S1470-2045(24)00064-0. |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Duration of follow-up (months) was defined as ((last visit date - enrollment date + 1)/365.25) × 12. Last visit date was the date of last clinical visit for ongoing participants, date of death for participants who died, or the last known contact date in survival follow-up for other participants who discontinued study drug.
A total of 181 participants were enrolled and treated at clinic centers in Japan, United States, France, Netherlands, and Spain.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: HER2 Overexpressing | Participants with HER2-overexpressing(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Jul 14, 2020 |
Not provided
Not provided
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|
| From screening, up to 36 months (data cut-off) |
| Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) | Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on independent central review and investigator assessment is reported. | From screening to documented tumor progression or death from any cause, up to 36 months (data cut-off) |
| Progression-Free Survival (PFS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) | Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. PFS based on independent central review and investigator assessment is reported. | From date of enrollment to first objective radiographic tumor progression or death from any cause,, up to 36 months (data cut-off) |
| Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) | Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause. | From date of enrollment to death from any cause, up to 36 months (data cut-off) |
| Percentage of Participants With Disease Control Rate (DCR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) | Disease Control Rate (DCR) was defined as the percentage of participants who achieved a best overall response of CR, PR, or stable disease (SD) during study treatment. Confirmation of CR/PR was required. DCR based on independent central review and investigator assessment is reported. | From first dose, up to 36 months (data cut-off) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Washington University School of Medicine at St. Louis | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Washington | Seattle | Washington | 98109 | United States |
| Centre Leon Berard | Lyon | Rhne | 69008 | France |
| Hôpital Nord - CHU Marseille | Marseille | 12915 | France |
| CHU Larrey | Toulouse | 31059 | France |
| Hôpital Larrey, CHU-Toulouse | Toulouse | 31059 | France |
| Institut Gustave Roussy | Villejuif | ÃŽle-de-France Region | 94805 | France |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| Kindai University Hospital | ÅŒsaka-sayama | Osaka | 589-8511 | Japan |
| Shizuoka Cancer Center | Nakatogari | Sunto-gun | 411-8777 | Japan |
| National Cancer Center Hospital | Chuo Ku | Tokyo | 104-0045 | Japan |
| Netherlands Cancer Institute | Amsterdam | 1066CX | Netherlands |
| Hospital Universitari Vall d'Hebron | Barcelona | 8035 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| 34534430 | Derived | Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazieres J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Perol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Janne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022 Jan 20;386(3):241-251. doi: 10.1056/NEJMoa2112431. Epub 2021 Sep 18. |
| FG001 | Cohort 1a: HER2 Overexpressing | Participants with HER2-overexpressing (immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. |
| FG002 | Cohort 2: HER2 Mutated | Participants with HER2-mutated, unresectable and/or metastatic NSCLC to who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. |
| COMPLETED | Study was Completed as last participant transitioned to alternative study |
|
| NOT COMPLETED |
|
|
Baseline characteristics were assessed using the Safety Analysis Set.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: HER2 Overexpressing | Participants with HER2-overexpressing(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. |
| BG001 | Cohort 1a: HER2 Overexpressing | Participants with HER2-overexpressing (immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. |
| BG002 | Cohort 2: HER2 Mutated | Participants with HER2-mutated, unresectable and/or metastatic NSCLC to who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Percentage of Participants With Objective Response Rate (ORR) Based on Independent Central Review Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) | The Objective Response Rate (ORR) was the defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by independent central review (ICR) committee based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on ICR is reported. | Objective response rate was assessed in the Full Analysis Set at data cut-off date of 03 December 2021. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From screening, up to 36 months (data cut-off) |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response Rate (ORR) Based on Investigator Assessment Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) | The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on investigator assessment is reported. | Objective response rate was assessed in the Full Analysis Set at data cut-off date of 03 May 2021. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From screening, up to 36 months (data cut-off) |
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) | Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on independent central review and investigator assessment is reported. | Duration of Response (DoR) was assessed in the Full Analysis Set of participants with confirmed CR/PR at data cut-off date of 03 May 2021. | Posted | Median | 95% Confidence Interval | months | From screening to documented tumor progression or death from any cause, up to 36 months (data cut-off) |
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) | Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. PFS based on independent central review and investigator assessment is reported. | Progression-free survival (PFS) was assessed in the Full Analysis Set at data cut-off date of 03 May 2021. | Posted | Median | 95% Confidence Interval | months | From date of enrollment to first objective radiographic tumor progression or death from any cause,, up to 36 months (data cut-off) |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) | Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause. | Overall survival (OS) was assessed in the Full Analysis Set at data cut-off date of 03 May 2021. | Posted | Median | 95% Confidence Interval | months | From date of enrollment to death from any cause, up to 36 months (data cut-off) |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Disease Control Rate (DCR) Following Treatment With DS8201a in Participants With HER2-Over-Expressing or -Mutated Non-Small-Cell Lung Cancer (NSCLC) | Disease Control Rate (DCR) was defined as the percentage of participants who achieved a best overall response of CR, PR, or stable disease (SD) during study treatment. Confirmation of CR/PR was required. DCR based on independent central review and investigator assessment is reported. | Disease control rate was assessed in the Full Analysis Set at data cut-off date of 03 May 2021. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose, up to 36 months (data cut-off) |
|
Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, up 36 months.
A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: HER2 Overexpressing | Participants with HER2-overexpressing(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. | 42 | 49 | 28 | 49 | 46 | 49 |
| EG001 | Cohort 1a: HER2 Overexpressing | Participants with HER2-overexpressing (immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. | 32 | 41 | 18 | 41 | 41 | 41 |
| EG002 | Cohort 2: HER2 Mutated | Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. | 72 | 91 | 40 | 91 | 91 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease Progression | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Central Nervous System Necrosis | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal Sepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Acute Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Covid-19 Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Duodenal Stenosis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Duodenal Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Electrocardiogram T Wave Abnormal | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Enterocolitis Infectious | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastrointestinal Motility Disorder | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hepatic Encephalopathy | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intestinal Perforation | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intra-Abdominal Haematoma | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.0) | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oesophageal Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Oesophageal Obstruction | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Partial Seizures | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumocystis Jirovecii Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia Staphylococcal | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Radiation Necrosis | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Small Intestinal Haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Staphylococcal Bacteraemia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Transfusion Reaction | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
| |
| Troponin I Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Troponin Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Upper Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Disease Complication | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA (23.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Haemorrhoidal Haemorrhage | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| White Blood Cell Count Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Lymphocyte Count Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Electrocardiogram Qt Prolonged | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Rash Maculo-Papular | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Muscluar Weakness | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (23.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (23.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo_us@daiichisankyo.com |
| Apr 25, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009362 | Neoplasm Metastasis |
| 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 |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000614160 | trastuzumab deruxtecan |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Japan |
|
| France |
|
| Spain |
|
| OG002 | Cohort 2: HER2 Mutated | Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. |
|
|
| OG002 | Cohort 2: HER2 Mutated | Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. |
|
|
| OG002 | Cohort 2: HER2 Mutated | Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. |
|
|
| Cohort 2: HER2 Mutated |
Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. |
|
|
| OG002 | Cohort 2: HER2 Mutated | Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a). Trastuzumab deruxtecan: Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion. |
|
|