GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations
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|ClinicalTrials.gov Identifier: NCT02047903|
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : January 9, 2020
Last Update Posted : January 9, 2020
|Condition or disease||Intervention/treatment|
|Carcinoma, Non-Small-Cell Lung||Drug: Afatinib|
|Study Type :||Observational|
|Actual Enrollment :||161 participants|
|Official Title:||An Observational Study of GIOTRIF (Afatinib) for First Line Therapy in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR)-Mutations.|
|Actual Study Start Date :||March 5, 2014|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
50, 40, 30 or 20 mg
- Progression Free Survival (PFS) Rate After 12 Months [ Time Frame: After 12 months ]The rate (probability) of being progression free after 12 months. PFS is defined as the time from first administration of the trial drug until objective tumor progression or death. The rate is the Kaplan-Meier estimated percent probability.
- Objective Response Rate (ORR) [ Time Frame: From the initial dose of study drug until end of the treatment period, up to 48 months. ]Objective response rate is calculated as a percentage of participants with complete response (CR) or partial response (PR) (i.e CR+PR) as best unconfirmed response. Here CR and PR were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate.
- Disease Control Rate (DCR) [ Time Frame: From the initial dose of study drug until end of the treatment period, up to 48 months. ]Percentage of participants with controlled disease (CR + PR + stable disease (SD)) as best unconfirmed response. CR, PR and SD were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate
- Progression Free Survival (PFS) [ Time Frame: From first administration of the trial drug until objective tumour progression or death, up to 48 months. ]PFS was measured from start of therapy until progression or death, whichever came first. Progression was defined as the minimum of the first examination with progression and the date of progression documented by the treating physician. One day was added to the corresponding date. Patients without documented progression and not known to have died were censored at their date of last examination and one day was added. Median was derived by Kaplan Meier methods.
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months. ]Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).
- Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia [ Time Frame: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months. ]Toxicity and side-effect profile: incidence of diarrhea, skin reactions, stomatitis and paronychia. Skin reactions: acne, dermatitis acneiform, dry skin, pruritus, rash, rash maculo-papular, rash pustular.
- Treatment Duration [ Time Frame: From the initial dose of study drug until end of the treatment period, up to 48 months. ]Duration of treatment with afatinib is calculated as Date of last administration + 1 day - Date of first administration.
- Symptom Control - Time to Worsening (Cough, Dyspnea and Pain) [ Time Frame: Up to 48 months ]Symptom control was evaluated for cough, dyspnea and pain. Time to deterioration was calculated from date of baseline European Organisation for Research and Treatment of Cancer (EORTC) questionnaire until date of the EORTC questionnaire, where the first deterioration was measured. Patients without deterioration were censored at their date of last answered EORTC questionnaire, where the corresponding scale is evaluable. Participants had to select one answer on a scale ranging from 1=Not at All to 4=Very Much for questions 1 to 28 and 31 to 43 and on scale ranging from 1=Very Bad to 7=Excellent for questions 29 and 30. Afterwards, these scale scores were linearly transformed such that all scales ranged from 0 to 100, where higher scores represented higher level of symptoms.
- Percentage of Participants With Treatment Modification [ Time Frame: From the initial dose of study drug until end of the treatment period, up to 48 months. ]Percentage of participants with treatment modification was calculated as percentage of participants with any dose reduction, dose escalation or any modification.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047903
|Multiple Locations, Germany|
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|