Brief Summary
This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.
Brief Title
Real World Data on Gi(l)Otrif® Dose Adjustment
Completion Date
Completion Date Type
Actual
Conditions
Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
Inclusion criteria:
1. Age = 18 years
2. Patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), tyrosine kinase inhibitors (TKI)-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label
3. Signed and dated written informed consent per regulations. (Exemption of a written informed consent for retrospective observational studies in some countries per local regulations and legal requirements.)
Exclusion criteria:
1. Any contraindication to Gi(l)otrif® as specified in label.
2. Patients with uncommon mutations are excluded as uncommon mutations are not within label in all participating countries (e.g. USA).
3. Patients still on treatment with Gi(l)otrif® will be excluded unless treatment period is \> or = 6 months.
4. Patients treated with Gi(l)otrif® within an interventional trial.
1. Age = 18 years
2. Patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), tyrosine kinase inhibitors (TKI)-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label
3. Signed and dated written informed consent per regulations. (Exemption of a written informed consent for retrospective observational studies in some countries per local regulations and legal requirements.)
Exclusion criteria:
1. Any contraindication to Gi(l)otrif® as specified in label.
2. Patients with uncommon mutations are excluded as uncommon mutations are not within label in all participating countries (e.g. USA).
3. Patients still on treatment with Gi(l)otrif® will be excluded unless treatment period is \> or = 6 months.
4. Patients treated with Gi(l)otrif® within an interventional trial.
Inclusion Criteria
Inclusion criteria:
1. Age = 18 years
2. Patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), tyrosine kinase inhibitors (TKI)-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label
3. Signed and dated written informed consent per regulations. (Exemption of a written informed consent for retrospective observational studies in some countries per local regulations and legal requirements.)
1. Age = 18 years
2. Patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), tyrosine kinase inhibitors (TKI)-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label
3. Signed and dated written informed consent per regulations. (Exemption of a written informed consent for retrospective observational studies in some countries per local regulations and legal requirements.)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02751879
Org Class
Industry
Org Full Name
Boehringer Ingelheim
Org Study Id
1200.270
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Real-world Data on Gi(l)Otrif® Dose Adjustment in First-line Treatment, TKI-naïve, Advanced Non-small Cell Lung Cancer Patients With EGFR Activating Mutations
Primary Outcomes
Outcome Description
An adverse drug reaction (ADR) is defined as a response to a medicinal product which is noxious and unintended. Grade 1, Grade 2, Grade 3 and Grade 4 ADR severity classes were considered for assessment of this outcome.
Outcome Measure
Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class.
Outcome Time Frame
From signing the informed consent onwards until the end of the study, up to 104 weeks.
Outcome Description
Time on treatment with Gi(l)otrif® in real-world setting has been calculated in this assessment. Time on treatment refers to time to treatment failure with Gi(l)otrif®
Outcome Measure
Time on Treatment With Gi(l)Otrif®
Outcome Time Frame
From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Outcome Description
Time to progression was calculated from the date of first dose of Gi(l)otrif® treatment to the earliest date of documented progression (clinical, radiographic or both clinical/radiographic progression) or tumour-related death, whatever occurred first.
Outcome Measure
Time to Progression With Gi(l)Otrif®
Outcome Time Frame
From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Secondary Outcomes
Outcome Description
Percentage of patients with a modified starting dose that is dose other than the recommended 40 mg daily of Gi(l)otrif® has been calculated to assess this outcome measure.
Outcome Time Frame
From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Outcome Measure
Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif®
Outcome Description
Different reasons for starting dose with modified dose that is dose other than recommended 40 mg once daily.
Outcome Time Frame
From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Outcome Measure
Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif®
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
NSCLC patients
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Balazs Halmos
Investigator Email
bahalmos@montefiore.org
Investigator Phone
Categories Mesh Debug
Lung & Chest Cancers --- CARCINOMA, NON-SMALL-CELL LUNG
Lung & Chest Cancers --- CARCINOMA, BRONCHOGENIC
Lung & Chest Cancers --- BRONCHIAL NEOPLASMS
Lung & Chest Cancers --- LUNG NEOPLASMS
Lung & Chest Cancers --- RESPIRATORY TRACT NEOPLASMS
Lung & Chest Cancers --- THORACIC NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
CARCINOMA, NON-SMALL-CELL LUNG
CARCINOMA, BRONCHOGENIC
BRONCHIAL NEOPLASMS
LUNG NEOPLASMS
RESPIRATORY TRACT NEOPLASMS
THORACIC NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
LUNG DISEASES
RESPIRATORY TRACT DISEASES