- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01121393
BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)
LUX-Lung 6: A Randomized, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Busan, Corea, república de, 602-702
- Kosin University Gospel Hospital
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Cheongju, Corea, república de, 361711
- Chungbuk National University Hospital
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Daegu, Corea, república de, 705-717
- Yeungnam University Medical Center
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Seoul, Corea, república de, 143-729
- Konkuk University Medical Center
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Seoul, Corea, república de, 152-703
- Korea University Guro Hospital
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Beijing, Porcelana, 100071
- 307 Hospital of PLA
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Beijing, Porcelana, 100730
- Peking Union Medical College Hospital
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Beijing, Porcelana, 100020
- Beijing Chao-Yang Hospital
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Beijing, Porcelana, 101149
- Beijing Chest Hospital
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Changchun, Porcelana, 130021
- First Hospital of Jilin University
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Changsha, Porcelana, 410008
- Xiangya Hospital, Central South University
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Changsha, Porcelana
- Hunan Province Tumor Hospital
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Chengdu, Porcelana, 610041
- West China Hospital
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Fuzhou, Porcelana, 350014
- Fujian Provincial Tumor Hospital
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Guangzhou, Porcelana, 510080
- Guangdong General Hospital
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Guangzhou, Porcelana, 510120
- Guangzhou Institute of Respiratory Disease
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Guangzhou, Porcelana, 510515
- NanFang Hosptial
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Haerbin, Porcelana, 150081
- The Third Affiliated Hospital of Harbin Medical University
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Hangzhou, Porcelana, 310022
- Zhejiang Cancer Hospital
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HongShan, Porcelana
- Hubei Cancer Hospital
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Kunming, Porcelana, 650118
- Yunnan Provincial Tumor Hospital
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Linyi, Porcelana, 276001
- Lin Yi Tumor Hospital
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Nan Ning, Porcelana
- The Affiliated Cancer Hospital, Guangxi Medical University
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Nanjing, Porcelana, 210009
- Jiangsu Cancer Hospital
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Nanjing, Porcelana, 210002
- the 81th Hospital of PLA
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Qingdao, Porcelana, 266101
- The affiliated hospital of medicalcollege qingdao university
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Shanghai, Porcelana, 200030
- Shanghai Chest Hospital
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Shanghai, Porcelana, 200433
- Shanghai Pulmonary Hospital
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Shanghai, Porcelana, 200032
- Zhongshan Hospital Fudan University
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Shanghai, Porcelana, 200003
- Shanghai Changzheng Hospital
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Shanghai, Porcelana, 200443
- Changhai Hospital
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Shenyang, Porcelana, 110001
- The First Hospital of Chinese Medical University
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Shijiazhuang, Porcelana
- Hebei Provincial Tumor Hospital
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Xi'An, Porcelana, 710038
- Tangdu Hospital
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Yangzhou, Porcelana, 225001
- Northern Jiangsu People's Hospital
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Songkla, Tailandia, 90110
- Songklanagarind hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria:
- pathologically confirmed diagnosis of stage IIIB or stage IV adenocarcinoma of the Lung
- EGFR(Epidermal Growth Factor Receptor) mutation detected by central laboratory analysis of tumor biopsy material
- Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST)1.1
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
- Age>=18 years
- life expectancy of at least three months
- Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines.
Exclusion criteria:
- Prior chemotherapy for relapsed and/or metastatic NSCLC.
- Prior treatment with EGFR targeting small molecules or antibodies.
- Radiotherapy or surgery(other than biopsy) within 4 weeks prior to randomization
- Active brain metastases
- Any other current malignancy or malignancy diagnosed within the past 5 years
- Known pre-existing interstitial lung disease
- Significant or recent acute gastrointestinal disorders with diarrhoea as a a major symptoms.
- History or presence of clinically relevant cardiovascular abnormalities
- Cardiac left ventricular function with resting ejection fraction of less than 50%.
- Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
- Absolute neutrophil count(ANC)<1500/mm3
- Platelet count<100,000/mm3
- Creatinine clearance<60ml/min or serum creatinine>1.5 times Upper Limit of Normal (ULN).
- Bilirubin>1.5 times ULN
- Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) > 3 times ULN
- Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial
- Pregnancy of breast-feeding
- Patients unable to comply with the protocol
- Active hepatitis B infection, active hepatitis C infection or known HIV(Human Immunodeficiency Virus) carrier.
- Known or suspected active drug or alcohol abuse.
- requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2
- Any contraindications for therapy with gemcitabine/cisplatin
- Known hypersensitivity to BIBW2992 or the excipient of any of the trial drugs
- Use of any investigational drug within 4 weeks of randomization.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Arm A BIBW 2992
Patients receive a tablet of BIBW 2992 daily until progression or unacceptable toxicity
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starting dose is 40 mg, in the event of no or minimal drug-related adverse events after one course, the dose will be increased to 50mg. in the event of certain drug related Adverse Event (AE), dose reduction will be increments of 10 mg, with the lowest dose being 20mg.
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Comparador activo: Arm B Chemotherapy
Patients receive Gemcitabine and Cisplatin, maximum is 6 courses
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Gemcitabine d1,8, Cisplatin d1, 21 days as a course, up to 6 courses.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Progression-free Survival
Periodo de tiempo: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168
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The primary endpoint was progression-free survival (PFS) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Progression-free survival was defined as the time from randomisation to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not have a PFS. Only data collected up until the analysis cut-off date (27 December 2013) were considered. Median time results from unstratified Kaplan-Meier estimates. |
Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 168
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Objective Response (OR)
Periodo de tiempo: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
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OR is defined as a best overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with OR. CR is defined as the disappearance of all target lesions and non-target lesions and no new lesions. PR is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD, non-Progressive Disease or non evaluation of all non-target lesions and no new lesions. (Exact 95% Confidence interval by Clopper and Pearson.) |
Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
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Disease Control (DC)
Periodo de tiempo: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
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DC is defined as a patient with objective response (OR) or stable disease (SD) assessed by central independent review according to RECIST version 1.1 and will be presented as the percentage of patients with DC.
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Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
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Overall Survival (OS)
Periodo de tiempo: From randomisation up to 374 weeks
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OS is defined as the time from randomisation to death. For patients who had not died until 7 December 2017, the date they were last known to be alive was derived from patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date. Median time results from unstratified Kaplan-Meier estimates. |
From randomisation up to 374 weeks
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Time to Objective Response (OR)
Periodo de tiempo: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
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OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1. For patients with an objective response, time to objective response was defined as the time from randomisation to the first objective response. Outcome data are the percentage of patients with OR by each scheduled tumour assessment. |
Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
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Duration of Objective Response
Periodo de tiempo: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
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OR is defined as a best of overall response of complete response (CR) or partial response (PR) assessed by central independent review according to RECIST version 1.1. For patients with an objective response, duration of objective response was defined as the time from the first objective response to disease progression or death whichever occurs earlier. A pre-defined set of censoring rules were used for patients who did not progress/die. The Median values are Kaplan-Meier estimates. |
Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
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Duration of Disease Control
Periodo de tiempo: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
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For patients with disease control, duration of disease control was defined as the time from randomisation to progression or death whichever occurs first.
A pre-defined set of censoring rules were used for patients who did not progress/die.
The Median values are Kaplan-Meier estimates.
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Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
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Tumour Shrinkage
Periodo de tiempo: Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
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Tumour shrinkage is calculated as the minimum post-baseline sum of longest diameters of target lesions (longest for non-nodal lesions, short axis for nodal lesions) (SLD), as assessed by central independent review. The mean of these minimum values are presented after adjusting for baseline sum of longest diameters and EGFR mutation category. Only data collected up until the analysis cut-off date (27 Dec 2013) were considered. A negative value means the smallest post-baseline SLD was smaller than baseline (decreased since baseline); a positive value means tumor size increased since baseline. The means are adjusted for baseline sum of lesions and EGFR mutation category. |
Tumour assessment were performed at screening, week 6, 12, 18, 24, 30, 36, 42, 48 and then every 12 weeks until progression or death whichever occurs first up to week 374
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Change From Baseline in Body Weight
Periodo de tiempo: Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
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The change from baseline to the lowest and the last body weight recorded or during the the study.
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Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
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Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Periodo de tiempo: Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
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The last ECOG performance score category recorded during the study. Outcome data are the percentage of patients with an shift of ECOG performance status from baseline to the last ECOG performance status. ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction;
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Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
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Health Related Quality of Life (HRQOL): Time of Deterioration in Coughing
Periodo de tiempo: Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
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HRQOL as measured by standardised questionnaires (EuropeanOrganisation for Research and Treatment of Cancer (EORTC)) quality of life questionaires (OLQ-C30) and its lung cancer module (QLQ-LC13). Analysis for cough: QLQ-LC13, question 1. Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates. |
Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
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Health Related Quality of Life (HRQOL): Time of Deterioration in Dyspnoea
Periodo de tiempo: Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
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HRQOL as measured by OLQ-C30 and its lung cancer module (QLQ-LC13). Analysis for dyspnoea: composite of QLQ-LC13, questions 3 to 5; individual item from QLQ-C30, question 8. Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates. |
Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
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Health Related Quality of Life (HRQOL): Time of Deterioration in Pain
Periodo de tiempo: Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
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HRQOL as measured by OLQ-C30 and its lung cancer module QLQ-LC13. Analysis for pain: composite of QLQ-C30, questions 9 and 19; individual items from QLQ-LC13, questions 10, 11 and 12. Time to deterioration was defined as the time from randomisation to a score increase (i.e. worsened) of at least 10 points from baseline (0 to 100 point scale). Patients without deterioration (including those with disease progression) were censored at the date of the last available HRQOL assessment; patients without post-baseline assessments were censored at the date of randomisation. Patients were considered as having deteriorated at the time of death. The median is Kaplan-Meier estimates. |
Baseline and throughout the study (every 3 weeks) until progression or death (whichever occurs first) up to 374 weeks.
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Pharmacokinetics of Afatinib at Day 22
Periodo de tiempo: Day 22 (course 2, visit 1)
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Outcome data are the trough plasma concentrations of afatinib at day 22 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the Pharmacokinetics (PK) assessment period).
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Day 22 (course 2, visit 1)
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Pharmacokinetics of Afatinib at Day 29
Periodo de tiempo: Day 29 (course 2, visit 2)
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Outcome data are the trough plasma concentrations of afatinib at day 29 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).
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Day 29 (course 2, visit 2)
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Pharmacokinetics of Afatinib at Day 43
Periodo de tiempo: Day 43 (course 3, visit 1)
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Outcome data are the trough plasma concentrations of afatinib at day 43 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).
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Day 43 (course 3, visit 1)
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Safety of Afatinib as Indicated by Intensity and Incidence of Adverse Events
Periodo de tiempo: From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.
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Safety of Afatinib as indicated by intensity and incidence of adverse events graded according to the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Presented as the percentage of patients with an Adverse Events during the on-treatment period by highest CTCAE grade.
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From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.
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Changes in Safety Laboratory Parameters
Periodo de tiempo: From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.
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Outcome data presented are the percentage of patients by worst CTCAE grade (only Grades 2 to 4 presented) on treatment for the following laboratory parameters: Potassium, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine and Creatine Kinase. For Potassium; only CTCAE grades resulting from hypokalemia (low values) are presented. |
From first administration of study medication up to 28 days after the last administration of study medication up to 374 weeks.
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Wu YL, Xu CR, Hu CP, Feng J, Lu S, Huang Y, Li W, Hou M, Shi JH, Marten A, Fan J, Peil B, Zhou C. Afatinib versus gemcitabine/cisplatin for first-line treatment of Chinese patients with advanced non-small-cell lung cancer harboring EGFR mutations: subgroup analysis of the LUX-Lung 6 trial. Onco Targets Ther. 2018 Nov 30;11:8575-8587. doi: 10.2147/OTT.S160358. eCollection 2018.
- Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Marten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17.
- Yang JC, Sequist LV, Zhou C, Schuler M, Geater SL, Mok T, Hu CP, Yamamoto N, Feng J, O'Byrne K, Lu S, Hirsh V, Huang Y, Sebastian M, Okamoto I, Dickgreber N, Shah R, Marten A, Massey D, Wind S, Wu YL. Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials. Ann Oncol. 2016 Nov;27(11):2103-2110. doi: 10.1093/annonc/mdw322. Epub 2016 Sep 6.
- Schuler M, Wu YL, Hirsh V, O'Byrne K, Yamamoto N, Mok T, Popat S, Sequist LV, Massey D, Zazulina V, Yang JC. First-Line Afatinib versus Chemotherapy in Patients with Non-Small Cell Lung Cancer and Common Epidermal Growth Factor Receptor Gene Mutations and Brain Metastases. J Thorac Oncol. 2016 Mar;11(3):380-90. doi: 10.1016/j.jtho.2015.11.014. Epub 2016 Jan 25.
- Yang JC, Sequist LV, Geater SL, Tsai CM, Mok TS, Schuler M, Yamamoto N, Yu CJ, Ou SH, Zhou C, Massey D, Zazulina V, Wu YL. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015 Jul;16(7):830-8. doi: 10.1016/S1470-2045(15)00026-1. Epub 2015 Jun 4.
- Yang JC, Wu YL, Schuler M, Sebastian M, Popat S, Yamamoto N, Zhou C, Hu CP, O'Byrne K, Feng J, Lu S, Huang Y, Geater SL, Lee KY, Tsai CM, Gorbunova V, Hirsh V, Bennouna J, Orlov S, Mok T, Boyer M, Su WC, Lee KH, Kato T, Massey D, Shahidi M, Zazulina V, Sequist LV. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12.
- Wu YL, Zhou C, Hu CP, Feng J, Lu S, Huang Y, Li W, Hou M, Shi JH, Lee KY, Xu CR, Massey D, Kim M, Shi Y, Geater SL. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Feb;15(2):213-22. doi: 10.1016/S1470-2045(13)70604-1. Epub 2014 Jan 15.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Neoplasias por tipo histológico
- Neoplasias
- Enfermedades pulmonares
- Neoplasias por sitio
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Neoplasias Pulmonares
- Carcinoma de pulmón de células no pequeñas
- Adenocarcinoma
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Agentes Antivirales
- Inhibidores de enzimas
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Inhibidores de la proteína quinasa
- Gemcitabina
- Afatinib
Otros números de identificación del estudio
- 1200.34
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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