A Chart Review Study of Adults With Advanced NSCLC

NCT ID: NCT05207423

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

179 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-03

Study Completion Date

2023-02-13

Brief Summary

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The main aim is to see how treatment patterns and drugs might improve care for adults with advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon-20 driven mutations. Past medical records will be reviewed. No clinic visits or procedures will be required.

Detailed Description

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This is a retrospective, observational study in participants with advanced NSCLC with EGFR exon-20 driven mutations. This study will look at clinical outcomes, patterns of care and disease management strategies and healthcare resource utilization (HCRU) in a routine clinical practice setting in the real world.

The study will enroll approximately 218 participants. Participants who were treated at the participating sites between 01 January 2017 and 30 November 2021 will be included. The data will be collected retrospectively at the specialized centers from the participants medical records and notes. All the participants will be assigned to a single observational cohort:

• Participants With Advanced NSCLC With EGFR Exon-20 Mutations

This multi-center study will be conducted in Canada, France and Hong Kong. The overall duration of the study will be 6 months.

Conditions

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Non-small Cell Lung Cancer (NSCLC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants With Advanced NSCLC With EGFR Exon-20 Mutations

Participants diagnosed with advanced NSCLC with EGFR exon 20 insertions (ex20ins) mutations who were treated according to routine clinical practice will be observed retrospectively up to 6 months or until the end of follow-up.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Histologically/cytologically confirmed diagnosis of locally advanced or metastatic (Stage IIb to IV) NSCLC with EGFR ex20ins mutations (based on the evaluation by the treating center) between 01 January 2017 and 30 November 2021.
2. Followed-up at the site between 01 January 2017 and 30 November 2021 for his/her advanced NSCLC, irrespective of their current survival status.

Exclusion Criteria

1\. Participants whose investigator has access to fewer than two registered visits for his/her advanced NSCLC between 01 January 2017 and 30 November 2021.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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William Osler Health System

Brampton, Ontario, Canada

Site Status

Grand River Hospital

Kitchener, Ontario, Canada

Site Status

Ottawa Hospital Research Institute.

Ottawa, Ontario, Canada

Site Status

University Health Network Princess Margaret Cancer Research Tower (PMCRT) The MaRS Centre, East Tower

Toronto, Ontario, Canada

Site Status

Centre Hospitalier de Saint-Quentin

Saint-Quentin, Aisne, France

Site Status

Hopital Nord - CHU Marseille

Marseille, Bouches-du-Rhone, France

Site Status

Centre Francois Baclesse

Caen, Calvados, France

Site Status

Centre Georges Francois Leclerc

Dijon, Cote-d'Or, France

Site Status

CHU Brest - Hopital Morvan

Brest, Finistere, France

Site Status

Institut Bergonie

Bordeaux, Gironde, France

Site Status

Hopital Larrey

Toulouse, Haute Garonne, France

Site Status

Centre Hospitalier de la Region d'Annecy

Pringy, Haute Savoie, France

Site Status

Hopital Albert Calmette - CHU Lille

Lille, Nord, France

Site Status

Institut Curie - site de Paris

Paris, Paris, France

Site Status

CHU Clermont-Ferrand

Clermont-Ferrand, Puy De Dome, France

Site Status

Centre Leon Berard

Lyon, Rhone, France

Site Status

Hospices Civils de Lyon

Lyon, Rhone, France

Site Status

CHU Strasbourg - Nouvel Hopital Civil

Strasbourg, Rhone, France

Site Status

Centre Hospitalier Regional de la Reunion

Saint-Pierre, Seine Saint Denis, France

Site Status

Hospital Center Henri Duffaut

Avignon, Vaculuse, France

Site Status

Centre Hospitalier Intercommunal de Creteil

Créteil, Val De Marne, France

Site Status

CHU Poitiers - Hopital la Miletrie

Poitiers, Vienne, France

Site Status

Hopital de Versailles

Versailles, Yvelines, France

Site Status

Hopital Tenon

Paris, , France

Site Status

Pamela Youde Nethersole Eastern Hospital

Hong Kong, , Hong Kong

Site Status

Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status

Princess Margaret Hospital

Hong Kong, , Hong Kong

Site Status

Queen Elizabeth Hospital

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status

Tuen Mun Hospital

Hong Kong, , Hong Kong

Site Status

Countries

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Canada France Hong Kong

Related Links

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https://clinicaltrials.takeda.com/study-detail/380405177660454c?idFilter=%5B%22TAK-788-4002%22%5D

To obtain more information on the study, click here/on this link.

Other Identifiers

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TAK-788-4002

Identifier Type: -

Identifier Source: org_study_id

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