Clinical trial NCT02751879: Real World Data on Gi(l)Otrif® Dose Adjustment
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NSCLC patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class.
timeFrame: From signing the informed consent onwards until the end of the study, up to 104 weeks.
measure: Time on Treatment With Gi(l)Otrif®
timeFrame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
measure: Time to Progression With Gi(l)Otrif®
timeFrame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Secondary outcomes:
measure: Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif®
timeFrame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
measure: Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif®
timeFrame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Wien
country: Austria
facility: SMZ Baumgartner Hoehe Otto Wagner Spital
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver
state: British Columbia
city: Besancon
country: France
facility: HOP Jean Minjoz
city: Dijon Cedex
country: France
facility: HOP Dijon, Cardio-Pneumo, Dijon
city: Paris
country: France
facility: HOP Européen G. Pompidou
city: Paris
country: France
facility: HOP Tenon
city: Essen
country: Germany
facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Oldenburg
country: Germany
facility: Pius-Hospital, Oldenburg
city: Alessandria
country: Italy
facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
city: Lecce
country: Italy
facility: Azienda Ospedaliera Vito Fazzi
city: Aichi, Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
city: Okayama, Kurashiki
country: Japan
facility: Kurashiki Central Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National Univ. Hosp
city: Ciudad De México
country: Mexico
facility: Centro Medico ABC
city: Monterrey
country: Mexico
facility: Organización para Cuidado Integral en Oncología S.A de C.V
city: Zapopan
country: Mexico
facility: Unidad de Cancerologia
city: Bydgoszcz
country: Poland
facility: Medical Practice,Bogdan Zurawski,Private Practice,Bydgoszcz
city: Cracow
country: Poland
facility: Grzegorz Czyzewicz Specialised Medical Practice, Cracow
city: Poznan
country: Poland
facility: Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Badalona (Barcelona)
country: Spain
facility: Hospital Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Halmos B, Tan EH, Soo RA, Cadranel J, Lee MK, Foucher P, Hsia TC, Hochmair M, Griesinger F, Hida T, Kim E, Melosky B, Marten A, Carcereny E. Impact of afatinib dose modification on safety and effectiveness in patients with EGFR mutation-positive advanced NSCLC: Results from a global real-world study (RealGiDo). Lung Cancer. 2019 Jan;127:103-111. doi: 10.1016/j.lungcan.2018.10.028. Epub 2018 Nov 2.