Real World Data on Gi(l)Otrif® Dose Adjustment
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.
Checked against the public recordLast updated Aug 8, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- Boehringer Ingelheim
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Montefiore Medical CenterThe Bronx, New York
- Levine Cancer InstituteCharlotte, North Carolina
- SMZ Baumgartner Hoehe Otto Wagner SpitalVienna
- BC Cancer Agency - VancouverVancouver, British Columbia
- HOP Jean MinjozBesançon
- HOP Dijon, Cardio-Pneumo, DijonDijon
- HOP Européen G. PompidouParis
- HOP TenonParis
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbHEssen
- Klinikum NürnbergNuremberg
- Pius-Hospital, OldenburgOldenburg
- Azienda Ospedaliera Santi Antonio e Biagio e Cesare ArrigoAlessandria
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 8, 2019. Always confirm current availability with the study team.