Real World Data on Gi(l)Otrif® Dose Adjustment

Completed

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT02751879

Run by

Boehringer Ingelheim

People needed

228

Starts

2016-11-24

Expected to finish

2017-09-30

Last updated by the study team

2019-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age = 18 years
• 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
• 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.)

You may not qualify if…

• Any contraindication to Gi(l)otrif® as specified in label.
• Patients with uncommon mutations are excluded as uncommon mutations are not within label in all participating countries (e.g. USA).
• Patients still on treatment with Gi(l)otrif® will be excluded unless treatment period is > or = 6 months.
• Patients treated with Gi(l)otrif® within an interventional trial.

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• SMZ Baumgartner Hoehe Otto Wagner Spital — Vienna, Austria
• BC Cancer Agency - Vancouver — Vancouver, British Columbia, Canada
• HOP Jean Minjoz — Besançon, France
• HOP Dijon, Cardio-Pneumo, Dijon — Dijon, France
• HOP Européen G. Pompidou — Paris, France
• HOP Tenon — Paris, France
• Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH — Essen, Germany
• Klinikum Nürnberg — Nuremberg, Germany
• Pius-Hospital, Oldenburg — Oldenburg, Germany
• Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo — Alessandria, Italy
• Azienda Ospedaliera Vito Fazzi — Lecce, Italy
• Aichi Cancer Center Hospital — Aichi, Nagoya, Japan
• Kurashiki Central Hospital — Okayama, Kurashiki, Japan
• Centro Medico ABC — Mexico City, Mexico
• Organización para Cuidado Integral en Oncología S.A de C.V — Monterrey, Mexico
• Unidad de Cancerologia — Zapopan, Mexico
• Medical Practice,Bogdan Zurawski,Private Practice,Bydgoszcz — Bydgoszcz, Poland
• Grzegorz Czyzewicz Specialised Medical Practice, Cracow — Cracow, Poland
• Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland — Poznan, Poland
• National University Hospital — Singapore, Singapore
• National Cancer Centre — Singapore, Singapore
• Yeungnam University Medical Center — Daegu, South Korea
• Chonbuk National University Hospital — Jeonju, South Korea

Full record on ClinicalTrials.gov

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