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

NCT02751879 | Completed Results

• 1 other identifier: 1200.270
• Study Type: observational
• Target: 228
• Locations: 13 countries
• Sites: 29

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (2)

• 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 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.

Study Arms (1)

Non small cell lung cancer (NSCLC)

patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

NSCLC patients

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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (29)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28201, United States

Location

SMZ Baumgartner Hoehe Otto Wagner Spital

Vienna, 1140, Austria

Location

BC Cancer Agency - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

Location

HOP Jean Minjoz

Besançon, 25030, France

Location

HOP Dijon, Cardio-Pneumo, Dijon

Dijon, 21079, France

Location

HOP Européen G. Pompidou

Paris, 75908, France

Location

HOP Tenon

Paris, 75970, France

Location

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, 45147, Germany

Location

Klinikum Nürnberg

Nuremberg, 90419, Germany

Location

Pius-Hospital, Oldenburg

Oldenburg, 26121, Germany

Location

Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

Alessandria, 15121, Italy

Location

Azienda Ospedaliera Vito Fazzi

Lecce, 73100, Italy

Location

Aichi Cancer Center Hospital

Aichi, Nagoya, 464-8681, Japan

Location

Kurashiki Central Hospital

Okayama, Kurashiki, 710-8602, Japan

Location

Centro Medico ABC

Mexico City, 01120, Mexico

Location

Organización para Cuidado Integral en Oncología S.A de C.V

Monterrey, 64060, Mexico

Location

Unidad de Cancerologia

Zapopan, 45050, Mexico

Location

Medical Practice,Bogdan Zurawski,Private Practice,Bydgoszcz

Bydgoszcz, 85796, Poland

Location

Grzegorz Czyzewicz Specialised Medical Practice, Cracow

Krakow, 31331, Poland

Location

Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland

Poznan, 60-569, Poland

Location

National University Hospital

Singapore, 119228, Singapore

Location

National Cancer Centre

Singapore, 169610, Singapore

Location

Yeungnam University Medical Center

Daegu, 705-703, South Korea

Location

Chonbuk National University Hospital

Jeonju, 54907, South Korea

Location

Pusan National Univ. Hosp

Pusan, 49241, South Korea

Location

Hospital Germans Trias i Pujol

Badalona (Barcelona), 08916, Spain

Location

Hospital La Princesa

Madrid, 28006, Spain

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 30642537 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Due to non-interventional character there were no predefined examinations, retro- and prospective data could be collected, bias regarding AE documentation, participation of patients on treatment was limited due to one exclusion criterion

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 26, 2016
• Study Start: November 24, 2016
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-06

Locations

AU (1); PL (3); IT (2); KR (3); TW (1); US (2); ES (2); SG (2); DE (3); CA (1); JP (2); ME (3); FR (4)