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CompletedNot applicableNCT02751879
Official study title

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

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forCarcinoma, Non-Small-Cell Lung

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 8, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?29 U.S. locations

Locations may change over time.

Who runs it?Boehringer Ingelheim

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Boehringer Ingelheim
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.)

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Montefiore Medical CenterThe Bronx, New York
  • Levine Cancer InstituteCharlotte, North Carolina
  • SMZ Baumgartner Hoehe Otto Wagner SpitalVienna
  • BC Cancer Agency - VancouverVancouver, British Columbia
  • HOP Jean MinjozBesançon
  • HOP Dijon, Cardio-Pneumo, DijonDijon
  • HOP Européen G. PompidouParis
  • HOP TenonParis
  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbHEssen
  • Klinikum NürnbergNuremberg
  • Pius-Hospital, OldenburgOldenburg
  • Azienda Ospedaliera Santi Antonio e Biagio e Cesare ArrigoAlessandria

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 8, 2019. Always confirm current availability with the study team.

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