Carcinoma, Non-Small-Cell Lung
Conditions
Brief summary
At present there are no approved predictive tumour- or serum-derived biomarkers guiding usage of anti-angiogenic therapies in patients with adenocarcinoma of NSCLC.The objective of this NIS is to examine whether genetic/genomic markers (alone or combined with clinical covariates) could be used to predict OS in NSCLC patients eligible for treatment with Vargatef®. The investigations in this study are exploratory in nature and considered to be hypothesis generating. The results from these investigations may help to expand our understanding of the disease and the response to Vargatef®.
Detailed description
Purpose:
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age = 18 years. * Women and men with locally advanced, metastatic or locally recurrent NSCLC with histology of adenocarcinoma. * Signed and dated written informed consent. * Vargatef ® is initiated and administered in accordance with the SPC. * Available fixed and paraffin embedded (FPE) tumour tissue routinely obtained at diagnosis and/or at re-biopsy before the initiation of the first line treatment (either block or slides, minimum of 10 slides and up to 20 slides if possible at 5µm thickness).
Exclusion criteria
* Any contraindication to Vargatef® or docetaxel as specified in their respective labels. * Vargatef® initiated more than 7 days prior to inclusion in this NIS. * Patients participating simultaneously in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Overall Survival (OS) Event | From start of entering the study until death or last contact date, up to 42 months. | Overall survival (OS) was defined as the time from start of entering the study to time of death. For the analysis of overall survival, participants were censored at the date of the last contact if the physician was no longer able to contact a participants or caregiver, and the vital status could not otherwise be determined. Enrolled participants who never received the combination therapy of docetaxel and Vargatef® were censored on the day of enrolment. Calculation of OS: For participants with known date of death: OS \[days\] = date of death - date of treatment start + 1 For participants known to be alive by the end of the study or at follow-up visit: OS (censored) \[days\] = date of last contact when the Patient was known to be alive - date of treatment start + 1. |
Countries
Austria, Belgium, Denmark, Germany, Greece, Hungary, Italy, Lithuania, Luxembourg, Netherlands, Spain, Sweden, United Kingdom
Participant flow
Recruitment details
Non-interventional study based on newly collected data in patients with Non-Small Cell Lung Cancer of adenocarcinoma tumour, who, for the first time, received Vargatef® as part of the routine treatment according to the approved label (new users design), to explore whether genetic or genomic markers could be used to predict Overall Survival.
Pre-assignment details
Only subjects that met all the study inclusion criteria were to be entered in the study. All subjects were free to withdraw from the non-interventional study at any time for any reason given.
Participants by arm
| Arm | Count |
|---|---|
| 200mg Vargatef® Participants with Non-Small Cell Lung Cancer (NSCLC) were administered soft capsules of 200 milligram (mg) Vargatef® twice daily (except the day of docetaxel Infusion) in combination with 75mg/m² docetaxel every 21 days as indicated in the approved Labels of Vargatef® and docetaxel.
Participants were followed-up every 6 months until they died, were lost to follow-up, withdrew consent, or until the required number of Overall Survival Events had occurred, whichever occurred first. | 260 |
| Total | 260 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 68 |
| Overall Study | Adverse Event unrelated to Vargatef® | 8 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Not treated with Vargatef® | 3 |
| Overall Study | Other not defined above | 3 |
| Overall Study | Progressive Disease | 156 |
| Overall Study | Sponsor decision | 5 |
| Overall Study | Withdrawal by Subject | 7 |
| Overall Study | Worsening of Disease | 4 |
Baseline characteristics
| Characteristic | 200mg Vargatef® |
|---|---|
| Age, Continuous | 63.3 Years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 208 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 256 Participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 209 / 260 |
| other Total, other adverse events | 93 / 257 |
| serious Total, serious adverse events | 127 / 257 |
Outcome results
Primary
Number of Participants With Overall Survival (OS) Event
Overall survival (OS) was defined as the time from start of entering the study to time of death. For the analysis of overall survival, participants were censored at the date of the last contact if the physician was no longer able to contact a participants or caregiver, and the vital status could not otherwise be determined. Enrolled participants who never received the combination therapy of docetaxel and Vargatef® were censored on the day of enrolment. Calculation of OS: For participants with known date of death: OS \[days\] = date of death - date of treatment start + 1 For participants known to be alive by the end of the study or at follow-up visit: OS (censored) \[days\] = date of last contact when the Patient was known to be alive - date of treatment start + 1.
Time frame: From start of entering the study until death or last contact date, up to 42 months.
Population: Entered Set: All patients who entered the study, no matter if they actually had taken Vargatef®.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 200mg Vargatef® | Number of Participants With Overall Survival (OS) Event | 206 Participants |
95% CI: [0, 0.894]