Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

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.)

Exclusion criteria:

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.

Study is for people with:

Lung Cancer

Estimated Enrollment:

228

Study ID:

NCT02751879

Recruitment Status:

Completed

Sponsor:

Boehringer Ingelheim

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There are 29 Locations for this study

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Montefiore Medical Center
Bronx New York, 10461, United States
Levine Cancer Institute
Charlotte North Carolina, 28201, United States
SMZ Baumgartner Hoehe Otto Wagner Spital
Wien , 1140, Austria
BC Cancer Agency - Vancouver
Vancouver British Columbia, V5Z 4, Canada
HOP Jean Minjoz
Besancon , 25030, France
HOP Dijon, Cardio-Pneumo, Dijon
Dijon Cedex , 21079, France
HOP Européen G. Pompidou
Paris , 75908, France
HOP Tenon
Paris , 75970, France
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen , 45147, Germany
Klinikum Nürnberg
Nürnberg , 90419, Germany
Pius-Hospital, Oldenburg
Oldenburg , 26121, Germany
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
Alessandria , 15121, Italy
Azienda Ospedaliera Vito Fazzi
Lecce , 73100, Italy
Aichi Cancer Center Hospital
Aichi, Nagoya , 464-8, Japan
Kurashiki Central Hospital
Okayama, Kurashiki , 710-8, Japan
Yeungnam University Medical Center
Daegu , 705-7, Korea, Republic of
Chonbuk National University Hospital
Jeonju , 54907, Korea, Republic of
Pusan National Univ. Hosp
Pusan , 49241, Korea, Republic of
Centro Medico ABC
Ciudad De México , 01120, Mexico
Organización para Cuidado Integral en Oncología S.A de C.V
Monterrey , 64060, Mexico
Unidad de Cancerologia
Zapopan , 45050, Mexico
Medical Practice,Bogdan Zurawski,Private Practice,Bydgoszcz
Bydgoszcz , 85796, Poland
Grzegorz Czyzewicz Specialised Medical Practice, Cracow
Cracow , 31331, Poland
Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland
Poznan , 60-56, Poland
National University Hospital
Singapore , 11922, Singapore
National Cancer Centre
Singapore , 16961, Singapore
Hospital Germans Trias i Pujol
Badalona (Barcelona) , 08916, Spain
Hospital La Princesa
Madrid , 28006, Spain
China Medical University Hospital
Taichung , 40447, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

228

Study ID:

NCT02751879

Recruitment Status:

Completed

Sponsor:


Boehringer Ingelheim

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