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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001237-83 | EudraCT Number |
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This is a Phase 2, multicenter study designed to evaluate the efficacy and safety of trastuzumab emtansine administered as a single-agent in participants with HER2-positive (HER2 IHC 2+ or HER2 IHC 3+) advanced or metastatic NSCLC. Participants will be treated with trastuzumab emtansine administered intravenously at a dose of 3.6 milligrams per kilogram (mg/kg) on Day 1 of 21-day cycles until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort IHC2+ | Experimental | Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine. |
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| Cohort IHC3+ | Experimental | Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trastuzumab Emtansine | Drug | Trastuzumab emtansine will be administered intravenously (IV) at a dose of 3.6 mg/kg on Day 1 of every 21-day cycle until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the sponsor, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response as Per Investigator Assessment According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v. 1.1) | Objective response is defined as a complete response (CR) or partial response (PR) determined on two consecutive assessments ≥ 4 weeks apart, based on investigator assessment according to RECIST, Version 1.1. CR: disappearance of all target lesions; and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeters (mm). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | From Day 1 to disease progression (PD) or death from any cause, up to the clinical cutoff date (approximately 22 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Died | From Day 1 to death from any cause, up to the study completion date (approximately 43 months) | |
| Overall Survival (OS) | OS is defined as the time from first study drug administration to death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
Cancer-Related Criteria:
Cardiopulmonary Function Criteria:
General Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) | Jacksonville | Florida | 32256 | United States | ||
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Subjects were screened centrally for HER2 status, using archived tumor specimens from previously collected tissue, if available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort IHC2+ | Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine. |
| FG001 | Cohort IHC3+ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| From Day 1 to death from any cause, up to the study completion date (approximately 43 months) |
| Percentage of Participants With PFS Event of Disease Progression, as Per Investigator Assessment According to RECIST v. 1.1, or Death | PFS is defined as the time from first study drug administration to first documented disease progression, based on investigator assessment using RECIST, v1.1, or death from any cause during the study, whichever occurs first. Disease progression is defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. | From Day 1 to PD or death from any cause, up to the study completion date (approximately 43 months) |
| Progression-Free Survival (PFS) as Per Investigator Assessment According to RECIST v. 1.1 | PFS is defined as the time from first study drug administration to first documented disease progression, based on investigator assessment using RECIST, v1.1, or death from any cause during the study, whichever occurs first. Disease progression is defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. | From Day 1 to PD or death from any cause, up to the study completion date (approximately 43 months) |
| Percentage of Participants With DOR Event of Disease Progression, Assessed According to RECIST v1.1 | DOR is defined as the time from the initial documentation of response (CR or PR using RECIST, v1.1) to documented disease progression using RECIST v1.1 or death from any cause during the study. CR: disappearance of all target lesions; and 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 of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. | From first documented objective response to PD or death from any cause, up to the study completion date (approximately 43 months) |
| Duration of Objective Response (DOR) Assessed According to RECIST v1.1 | DoR is defined as the time from the initial documentation of response (CR or PR using RECIST, v1.1) to documented disease progression using RECIST v1.1 or death from any cause during the study. CR: disappearance of all target lesions; and 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 of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. | From first documented objective response to PD or death from any cause, up to the study completion date (approximately 43 months) |
| Percentage of Participants With Clinical Benefit as Per Investigator Assessment According to RECIST, v1.1 | Clinical benefit is defined as having a CR or PR or stable disease (using RECIST, v1.1) at 6 months. Participants with no post-baseline response assessment are considered as experiencing no clinical benefit. CR: disappearance of all target lesions; and 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 of diameters. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum while in the study. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. | From Day 1 to PD or death from any cause, up to the study completion date (approximately 43 months) |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, whether or not considered related to the study drug. A SAE is any experience that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant. | From Day 1 to 30 days after last dose of study drug, up to the study completion date (approximately 43 months) |
| Maximum Observed Concentration (Cmax) for Trastuzumab Emtansine and Total Trastuzumab | Cmax is the 0-21 day maximum observed concentration of a drug and was measured in blood serum. | Pre-dose (within 2 days) and 30 minutes (min) after end of infusion (infusion length= 100 min or less) on Day 1 of Cycles 1 and 3 (one cycle=21 days); at treatment discontinuation/early termination, up to primary analysis, approx. 22 months |
| AUCinf for Trastuzumab Emtansine and Total Trastuzumab | AUC (from zero to infinity) represents the total drug exposure over time in blood serum. | Pre-dose & 30 minutes (min) post-infusion (inf.) on Day (D) 1 of Cycles (C) 1 & 3; post- inf. on D 2, 3, 4 or 5, 8, & 15 of C 1, & pre- inf. on D1 of C2 & D1 of C 4 (C=21 D); at discontin./termination, up to primary analysis, approx. 22 months |
| Elimination Half-Life (t1/2) for Trastuzumab Emtansine and Total Trastuzumab | t1/2 is the time required for the drug serum concentration to be reduced to half. | Pre-dose & 30 minutes (min) post-infusion (inf.) on D 1 of C 1 & 3; post- inf. on D 2, 3, 4 or 5, 8, & 15 of C 1, & pre- inf. on D 1 of C 2 & D 1 of C 4 (C=21 days); at treatment discontin./early termination, up to primary analysis, approx. 22 months |
| Volume of Distribution (Vss) for Trastuzumab Emtansine and Total Trastuzumab | Vss is the volume of distribution of study drug at steady state. | Pre-dose & 30 minutes (min) post-infusion (inf.) on D1 of C1 & 3; post- inf. on D2, 3, 4 or 5, 8, & 15 of C 1, & pre- inf. on D 1 of C 2 & D1 of C 4 (C=21 days); at treatment discontin/early termination, up to primary analysis, approx. 22 months |
| Clearance (CL) for Trastuzumab Emtansine and Total Trastuzumab | CL is a measure of the body's elimination of a drug from blood serum over time. | Pre-dose & 30 minutes (min) post-infusion (inf.) on D 1 of C 1 & 3; post- inf. on D 2, 3, 4 or 5, 8, & 15 of C 1, & pre- inf. on D 1 of C 2 & D 1 of C 4 (C=21 days); at treatment discontin/early termination, up to primary analysis, approx. 22 months |
| Maximum Observed Concentration (Cmax) for N2'- Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) | Cmax is the maximum observed concentration of a drug and was measured in blood plasma. | Pre-dose (within 2 days) and 30 minutes (min) after end of infusion (infusion length= 100 min or less) on Day 1 of Cycle 1 (one cycle=21 days); at treatment discontinuation/early termination,up to primary analysis, approx. 22 months |
| Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs) | The presence of ADAs in blood serum is an indication of the body's immune response to a drug. | Pre-dose (within 2 days) on Day 1 of Cycles 1 and 3; at treatment discontinuation/early termination,up to primary analysis, approx. 22 months |
| Rush University Medical Center |
| Chicago |
| Illinois |
| 60612 |
| United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| HELIOS Klinikum Emil von Behring Klinik f.Pneumologie Onkologie u.Infektiologie | Berlin | 14165 | Germany |
| Kaiserswerther Diakonie Florence Nightingale-Krankenh. Tagesklinik f.Onkologie | Düsseldorf | 40489 | Germany |
| Asklepios-Fachkliniken Muenchen-Gauting; Onkologie | Gauting | 82131 | Germany |
| Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II | Halle | 06120 | Germany |
| Fachklinik für Lungenerkrankungen | Immenhausen | 34376 | Germany |
| Azienda Ospedaliera Univ Parma; Dept Oncologia Medica | Parma | Emilia-Romagna | 43100 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| Medical University of Gdansk | Gdansk | 80-211 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii | Otwock | 05-400 | Poland |
| Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii | Warsaw | 02-781 | Poland |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center - Oncology | Seoul | 05505 | South Korea |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Hospital Universitario La Paz; Servicio de Oncologia | Madrid | 28046 | Spain |
| Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia | Zaragoza | 50009 | Spain |
| CHUV; Departement d'Oncologie | Lausanne | 1011 | Switzerland |
| UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie | Zurich | 8091 | Switzerland |
Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort IHC2+ | Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine. |
| BG001 | Cohort IHC3+ | Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||
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| Primary | Percentage of Participants With Objective Response as Per Investigator Assessment According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v. 1.1) | Objective response is defined as a complete response (CR) or partial response (PR) determined on two consecutive assessments ≥ 4 weeks apart, based on investigator assessment according to RECIST, Version 1.1. CR: disappearance of all target lesions; and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 millimeters (mm). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | The efficacy-evaluable population included participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 to disease progression (PD) or death from any cause, up to the clinical cutoff date (approximately 22 months) |
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| Secondary | Percentage of Participants Who Died | The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with events. | Posted | Number | percentage of participants | From Day 1 to death from any cause, up to the study completion date (approximately 43 months) |
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| Secondary | Overall Survival (OS) | OS is defined as the time from first study drug administration to death from any cause. | The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with events. | Posted | Median | 95% Confidence Interval | months | From Day 1 to death from any cause, up to the study completion date (approximately 43 months) |
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| Secondary | Percentage of Participants With PFS Event of Disease Progression, as Per Investigator Assessment According to RECIST v. 1.1, or Death | PFS is defined as the time from first study drug administration to first documented disease progression, based on investigator assessment using RECIST, v1.1, or death from any cause during the study, whichever occurs first. Disease progression is defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. | The efficacy-evaluable population included participants who received at least one dose of study drug. | Posted | Number | percentage of participants | From Day 1 to PD or death from any cause, up to the study completion date (approximately 43 months) |
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| Secondary | Progression-Free Survival (PFS) as Per Investigator Assessment According to RECIST v. 1.1 | PFS is defined as the time from first study drug administration to first documented disease progression, based on investigator assessment using RECIST, v1.1, or death from any cause during the study, whichever occurs first. Disease progression is defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. | The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with events. | Posted | Median | 95% Confidence Interval | months | From Day 1 to PD or death from any cause, up to the study completion date (approximately 43 months) |
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| Secondary | Percentage of Participants With DOR Event of Disease Progression, Assessed According to RECIST v1.1 | DOR is defined as the time from the initial documentation of response (CR or PR using RECIST, v1.1) to documented disease progression using RECIST v1.1 or death from any cause during the study. CR: disappearance of all target lesions; and 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 of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. | The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with response. | Posted | Number | percentage of participants | From first documented objective response to PD or death from any cause, up to the study completion date (approximately 43 months) |
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| Secondary | Duration of Objective Response (DOR) Assessed According to RECIST v1.1 | DoR is defined as the time from the initial documentation of response (CR or PR using RECIST, v1.1) to documented disease progression using RECIST v1.1 or death from any cause during the study. CR: disappearance of all target lesions; and 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 of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. | The efficacy-evaluable population included participants who received at least one dose of study drug. Data are reported for participants with response. | Posted | Median | 95% Confidence Interval | months | From first documented objective response to PD or death from any cause, up to the study completion date (approximately 43 months) |
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| Secondary | Percentage of Participants With Clinical Benefit as Per Investigator Assessment According to RECIST, v1.1 | Clinical benefit is defined as having a CR or PR or stable disease (using RECIST, v1.1) at 6 months. Participants with no post-baseline response assessment are considered as experiencing no clinical benefit. CR: disappearance of all target lesions; and 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 of diameters. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum while in the study. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. | The efficacy-evaluable population included participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 to PD or death from any cause, up to the study completion date (approximately 43 months) |
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| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, whether or not considered related to the study drug. A SAE is any experience that: results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant. | The safety-evaluable population included participants who received at least one dose of study treatment. | Posted | Number | percentage of participants | From Day 1 to 30 days after last dose of study drug, up to the study completion date (approximately 43 months) |
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| Secondary | Maximum Observed Concentration (Cmax) for Trastuzumab Emtansine and Total Trastuzumab | Cmax is the 0-21 day maximum observed concentration of a drug and was measured in blood serum. | The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants. | Posted | Mean | Standard Deviation | micrograms per milliliter (ug/mL) | Pre-dose (within 2 days) and 30 minutes (min) after end of infusion (infusion length= 100 min or less) on Day 1 of Cycles 1 and 3 (one cycle=21 days); at treatment discontinuation/early termination, up to primary analysis, approx. 22 months |
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| Secondary | AUCinf for Trastuzumab Emtansine and Total Trastuzumab | AUC (from zero to infinity) represents the total drug exposure over time in blood serum. | The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants who consented to intense sampling. | Posted | Mean | Standard Deviation | days times ug/mL (day* ug/mL) | Pre-dose & 30 minutes (min) post-infusion (inf.) on Day (D) 1 of Cycles (C) 1 & 3; post- inf. on D 2, 3, 4 or 5, 8, & 15 of C 1, & pre- inf. on D1 of C2 & D1 of C 4 (C=21 D); at discontin./termination, up to primary analysis, approx. 22 months |
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| Secondary | Elimination Half-Life (t1/2) for Trastuzumab Emtansine and Total Trastuzumab | t1/2 is the time required for the drug serum concentration to be reduced to half. | The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants who consented to intense sampling. | Posted | Mean | Standard Deviation | days | Pre-dose & 30 minutes (min) post-infusion (inf.) on D 1 of C 1 & 3; post- inf. on D 2, 3, 4 or 5, 8, & 15 of C 1, & pre- inf. on D 1 of C 2 & D 1 of C 4 (C=21 days); at treatment discontin./early termination, up to primary analysis, approx. 22 months |
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| Secondary | Volume of Distribution (Vss) for Trastuzumab Emtansine and Total Trastuzumab | Vss is the volume of distribution of study drug at steady state. | The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants who consented to intense sampling. | Posted | Mean | Standard Deviation | milliliters kilogram (mL/kg) | Pre-dose & 30 minutes (min) post-infusion (inf.) on D1 of C1 & 3; post- inf. on D2, 3, 4 or 5, 8, & 15 of C 1, & pre- inf. on D 1 of C 2 & D1 of C 4 (C=21 days); at treatment discontin/early termination, up to primary analysis, approx. 22 months |
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| Secondary | Clearance (CL) for Trastuzumab Emtansine and Total Trastuzumab | CL is a measure of the body's elimination of a drug from blood serum over time. | The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants who consented to intense sampling. | Posted | Mean | Standard Deviation | mL/day/kg | Pre-dose & 30 minutes (min) post-infusion (inf.) on D 1 of C 1 & 3; post- inf. on D 2, 3, 4 or 5, 8, & 15 of C 1, & pre- inf. on D 1 of C 2 & D 1 of C 4 (C=21 days); at treatment discontin/early termination, up to primary analysis, approx. 22 months |
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| Secondary | Maximum Observed Concentration (Cmax) for N2'- Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) | Cmax is the maximum observed concentration of a drug and was measured in blood plasma. | The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Pre-dose (within 2 days) and 30 minutes (min) after end of infusion (infusion length= 100 min or less) on Day 1 of Cycle 1 (one cycle=21 days); at treatment discontinuation/early termination,up to primary analysis, approx. 22 months |
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| Secondary | Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs) | The presence of ADAs in blood serum is an indication of the body's immune response to a drug. | The pharmacokinetic (PK) population included participants who had received at least one dose of study treatment and had at least one serum or plasma concentration result available at clinical data cut-off. Data are reported for evaluable participants with post-dose sample available for ADA analysis. | Posted | Number | percentage of participants | Pre-dose (within 2 days) on Day 1 of Cycles 1 and 3; at treatment discontinuation/early termination,up to primary analysis, approx. 22 months |
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From baseline to study completion (approximately 43 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 | Cohort IHC2+ | Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine. | 23 | 29 | 5 | 29 | 24 | 29 |
| EG001 | Cohort IHC3+ | Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine. | 16 | 20 | 5 | 20 | 19 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDra, Version 21.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDra, Version 21.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDra, Version 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDra, Version 21.1 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDra, Version 21.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDra, Version 21.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra, Version 21.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDra, Version 21.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDra, Version 21.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDra, Version 21.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Chills | General disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Malaise | General disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Oedema | General disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Pulmonary pain | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDra, Version 21.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDra, Version 21.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDra, Version 21.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDra, Version 21.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDra, Version 21.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDra, Version 21.1 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDra, Version 21.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDra, Version 21.1 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDra, Version 21.1 | Systematic Assessment |
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| Skin Wound | Injury, poisoning and procedural complications | MedDra, Version 21.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDra, Version 21.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDra, Version 21.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDra, Version 21.1 | Systematic Assessment |
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| Paronychia | Infections and infestations | MedDra, Version 21.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Depressive symptom | Psychiatric disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Poor venous access | Vascular disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Odynophagia | Gastrointestinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Mucosal Dryness | General disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDra, Version 21.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Iron Deficiency | Metabolism and nutrition disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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| Onychoclasis | Skin and subcutaneous tissue disorders | MedDra, Version 21.1 | Systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000080044 | Ado-Trastuzumab Emtansine |
| ID | Term |
|---|---|
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000068878 | Trastuzumab |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
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Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine. |
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