Real World Data on Gi(l)Otrif® Dose Adjustment
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/7/2018 |
| Start Date: | November 24, 2016 |
| End Date: | September 30, 2017 |
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
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.
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.
Inclusion criteria:
1. Age = 18 years
2. Patients with EGFR mutation (common mutations), TKI-naïve advanced 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.
We found this trial at
3
sites
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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