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

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT02751879
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-26
• Study Start: 2016-11-24
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Results First Submitted: 2018-09-12
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-24
• Last Update Submitted: 2019-06-24
• Results First Posted: 2019-08-08
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class.	From signing the informed consent onwards until the end of the study, up to 104 weeks.	An adverse drug reaction (ADR) is defined as a response to a medicinal product which is noxious and unintended. Grade 1, Grade 2, Grade 3 and Grade 4 ADR severity classes were considered for assessment of this outcome.
Time on Treatment With Gi(l)Otrif®	From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.	Time on treatment with Gi(l)otrif® in real-world setting has been calculated in this assessment. Time on treatment refers to time to treatment failure with Gi(l)otrif®
Time to Progression With Gi(l)Otrif®	From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.	Time to progression was calculated from the date of first dose of Gi(l)otrif® treatment to the earliest date of documented progression (clinical, radiographic or both clinical/radiographic progression) or tumour-related death, whatever occurred first.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif®	From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.	Percentage of patients with a modified starting dose that is dose other than the recommended 40 mg daily of Gi(l)otrif® has been calculated to assess this outcome measure.
Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif®	From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.	Different reasons for starting dose with modified dose that is dose other than recommended 40 mg once daily.

Trial Locations

Locations (29)

SMZ Baumgartner Hoehe Otto Wagner Spital; 🇦🇹 Wien, Austria

BC Cancer Agency - Vancouver; 🇨🇦 Vancouver, British Columbia, Canada

Kurashiki Central Hospital; 🇯🇵 Okayama, Kurashiki, Japan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Hospital Germans Trias i Pujol; 🇪🇸 Badalona (Barcelona), Spain

National Cancer Centre; 🇸🇬 Singapore, Singapore

Grzegorz Czyzewicz Specialised Medical Practice, Cracow; 🇵🇱 Cracow, Poland

National University Hospital; 🇸🇬 Singapore, Singapore

Hospital La Princesa; 🇪🇸 Madrid, Spain

HOP Européen G. Pompidou; 🇫🇷 Paris, France

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States

HOP Jean Minjoz; 🇫🇷 Besancon, France

HOP Dijon, Cardio-Pneumo, Dijon; 🇫🇷 Dijon Cedex, France

Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Italy

HOP Tenon; 🇫🇷 Paris, France

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH; 🇩🇪 Essen, Germany

Klinikum Nürnberg; 🇩🇪 Nürnberg, Germany

Pius-Hospital, Oldenburg; 🇩🇪 Oldenburg, Germany

Aichi Cancer Center Hospital; 🇯🇵 Aichi, Nagoya, Japan

Azienda Ospedaliera Vito Fazzi; 🇮🇹 Lecce, Italy

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Unidad de Cancerologia; 🇲🇽 Zapopan, Mexico

Centro Medico ABC; 🇲🇽 Ciudad De México, Mexico

Organización para Cuidado Integral en Oncología S.A de C.V; 🇲🇽 Monterrey, Mexico

Pusan National Univ. Hosp; 🇰🇷 Pusan, Korea, Republic of

Medical Practice,Bogdan Zurawski,Private Practice,Bydgoszcz; 🇵🇱 Bydgoszcz, Poland

Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland; 🇵🇱 Poznan, Poland

Chonbuk National University Hospital; 🇰🇷 Jeonju, Korea, Republic of

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States