Carcinoma, Non-Small-Cell Lung
Conditions
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.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. | From signing the informed consent onwards until the end of the study, up to 104 weeks. | 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. |
| Time on Treatment With Gi(l)Otrif® | From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks. | 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® |
| Time to Progression With Gi(l)Otrif® | From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif® | From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks. | 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. |
| Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif® | From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks. | Different reasons for starting dose with modified dose that is dose other than recommended 40 mg once daily. |
Countries
Austria, Canada, France, Germany, Italy, Japan, Mexico, Poland, Singapore, South Korea, Spain, Taiwan, United States
Participant flow
Recruitment details
This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® tablet once daily as indicated in the approved labels. Between December 2016 and October 2017, 231 patients were screened for study participation and 228 patients were treated.
Pre-assignment details
All patients were screened for eligibility to participate in the study. Patients attended specialist sites which would then ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to study if any of the specific entry criteria were violated.
Participants by arm
| Arm | Count |
|---|---|
| Gi(l)Otrif ≥ 40 mg Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily. | 157 |
| Gi(l)Otrif ≤ 30 mg Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily. | 71 |
| Total | 228 |
Baseline characteristics
| Characteristic | Gi(l)Otrif ≤ 30 mg | Total | Gi(l)Otrif ≥ 40 mg |
|---|---|---|---|
| Age, Continuous | 68.10 Years STANDARD_DEVIATION 10.84 | 65.62 Years STANDARD_DEVIATION 11.74 | 64.50 Years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 25 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 176 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 27 Participants | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 100 Participants | 74 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 29 Participants | 22 Participants |
| Race (NIH/OMB) White | 37 Participants | 96 Participants | 59 Participants |
| Sex: Female, Male Female | 48 Participants | 138 Participants | 90 Participants |
| Sex: Female, Male Male | 23 Participants | 90 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 157 | 0 / 71 |
| other Total, other adverse events | 147 / 157 | 68 / 71 |
| serious Total, serious adverse events | 11 / 157 | 7 / 71 |
Outcome results
Primary
Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class.
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.
Time frame: From signing the informed consent onwards until the end of the study, up to 104 weeks.
Population: Full Analysis set (FAS): All registered patients with informed consent (as applicable with local regulations) and at least one administration of Gi(l)otrif®.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gi(l)Otrif ≥ 40 mg | Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. | Grade 1 | 21.02 Percentage of patients (%) |
| Gi(l)Otrif ≥ 40 mg | Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. | Grade 2 | 44.59 Percentage of patients (%) |
| Gi(l)Otrif ≥ 40 mg | Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. | Grade 3 | 24.84 Percentage of patients (%) |
| Gi(l)Otrif ≥ 40 mg | Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. | Grade 4 | 3.18 Percentage of patients (%) |
| Gi(l)Otrif ≤ 30 mg | Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. | Grade 4 | 0.00 Percentage of patients (%) |
| Gi(l)Otrif ≤ 30 mg | Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. | Grade 1 | 21.13 Percentage of patients (%) |
| Gi(l)Otrif ≤ 30 mg | Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. | Grade 3 | 16.90 Percentage of patients (%) |
| Gi(l)Otrif ≤ 30 mg | Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. | Grade 2 | 57.75 Percentage of patients (%) |
Primary
Time on Treatment With Gi(l)Otrif®
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®
Time frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gi(l)Otrif ≥ 40 mg | Time on Treatment With Gi(l)Otrif® | 18.22 Months |
| Gi(l)Otrif ≤ 30 mg | Time on Treatment With Gi(l)Otrif® | 19.41 Months |
Primary
Time to Progression With Gi(l)Otrif®
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.
Time frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gi(l)Otrif ≥ 40 mg | Time to Progression With Gi(l)Otrif® | 20.03 Months |
| Gi(l)Otrif ≤ 30 mg | Time to Progression With Gi(l)Otrif® | 25.92 Months |
Secondary
Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif®
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.
Time frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gi(l)Otrif ≥ 40 mg | Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif® | 50 mg | 2.74 Percentage of patients (%) |
| Gi(l)Otrif ≥ 40 mg | Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif® | 30 mg | 94.52 Percentage of patients (%) |
| Gi(l)Otrif ≥ 40 mg | Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif® | 20 mg | 2.74 Percentage of patients (%) |
Secondary
Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif®
Different reasons for starting dose with modified dose that is dose other than recommended 40 mg once daily.
Time frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gi(l)Otrif ≥ 40 mg | Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif® | Patient's condition | 0.00 Percentage of patients (%) |
| Gi(l)Otrif ≥ 40 mg | Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif® | Other | 0.00 Percentage of patients (%) |
| Gi(l)Otrif ≥ 40 mg | Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif® | Previous experience with EGFR-TKI | 0.00 Percentage of patients (%) |
| Gi(l)Otrif ≥ 40 mg | Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif® | Institutional standard | 100.00 Percentage of patients (%) |
| Gi(l)Otrif ≤ 30 mg | Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif® | Other | 40.85 Percentage of patients (%) |
| Gi(l)Otrif ≤ 30 mg | Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif® | Institutional standard | 15.49 Percentage of patients (%) |
| Gi(l)Otrif ≤ 30 mg | Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif® | Previous experience with EGFR-TKI | 5.63 Percentage of patients (%) |
| Gi(l)Otrif ≤ 30 mg | Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif® | Patient's condition | 38.03 Percentage of patients (%) |