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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02751879
• Other study ID #: 1200.270
• Status: Completed
• Start date: November 24, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: June 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Locations

Country	Name	City	State
Austria	SMZ Baumgartner Hoehe Otto Wagner Spital	Wien
Canada	BC Cancer Agency - Vancouver	Vancouver	British Columbia
France	HOP Jean Minjoz	Besancon
France	HOP Dijon, Cardio-Pneumo, Dijon	Dijon Cedex
France	HOP Européen G. Pompidou	Paris
France	HOP Tenon	Paris
Germany	Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH	Essen
Germany	Klinikum Nürnberg	Nürnberg
Germany	Pius-Hospital, Oldenburg	Oldenburg
Italy	Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo	Alessandria
Italy	Azienda Ospedaliera Vito Fazzi	Lecce
Japan	Aichi Cancer Center Hospital	Aichi, Nagoya
Japan	Kurashiki Central Hospital	Okayama, Kurashiki
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Pusan National Univ. Hosp	Pusan
Mexico	Centro Medico ABC	Ciudad De México
Mexico	Organización para Cuidado Integral en Oncología S.A de C.V	Monterrey
Mexico	Unidad de Cancerologia	Zapopan
Poland	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
Singapore	National Cancer Centre	Singapore
Singapore	National University Hospital	Singapore
Spain	Hospital Germans Trias i Pujol	Badalona (Barcelona)
Spain	Hospital La Princesa	Madrid
Taiwan	China Medical University Hospital	Taichung
United States	Montefiore Medical Center	Bronx	New York
United States	Levine Cancer Institute	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Singapore,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class.	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.	From signing the informed consent onwards until the end of the study, up to 104 weeks.
Primary	Time on Treatment With Gi(l)Otrif®	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®	From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Primary	Time to Progression With Gi(l)Otrif®	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.	From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Secondary	Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif®	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.	From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Secondary	Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif®	Different reasons for starting dose with modified dose that is dose other than recommended 40 mg once daily.	From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.

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