A Chart Review Study of Adults With Advanced NSCLC

Completed

• Conditions: Non-small Cell Lung Cancer (NSCLC)

• Registration Number: NCT05207423
• Lead Sponsor: Takeda

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-26
• Study Start: 2022-10-03
• Status Verified: 2023-02
• Primary Completion: 2023-02-13
• Study Completion: 2023-02-13
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Real-world Progression Free Survival (rwPFS)	Up to 6 months	rwPFS is defined as the time elapsed from the initiation of a new treatment line to real-world progressive disease (rwPD) or death, whichever occurred first. rwPD: unequivocal increase in visible disease/disease burden or presence of new lesions. Participants will be censored at the end of the line of therapy or date of last contact available.
Real-world Duration of Response (rwDOR)	Up to 6 months	rwDOR is defined as the time from the date of first rwCR or rwPR after treatment initiation to the date of the first noted occurrence of progressive disease or death. rwCR: complete resolution of disease, rwPR: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Real-world Overall Response Rate (rwORR)	Up to 6 months	Overall response rate (ORR) is the percentage of participants on a treatment line who achieve real-world complete response (rwCR) or real-world partial response (rwPR) as best response per treatment line. rwCR: complete resolution of disease; rwPR: partial reduction in size of visible disease in some, or all, areas without any increase in visible disease.
Real-world Time to Treatment Discontinuation (rwTTD)	Up to 6 months	rwTTD is defined as time from treatment initiation to treatment discontinuation for any reason. Treatment discontinuation is defined as the date of the last drug administered during the same treatment line of therapy or death, whichever occurs earlier. Participants are considered to discontinue treatment if they have advanced to a new line of therapy since the last drug administration, have a recorded date of death, or have no visit activity more than 120 days after the last drug administration.
Confirmed Real-world Overall Response Rate (rwCORR)	Up to 6 months	ORR is the percentage of participants on a treatment line who achieve confirmed rwCR or rwPR as best response per treatment line. Confirmed responses are responses that persist greater than or equal to (\>=) 4 weeks after initial response. rwCR: complete resolution of disease; rwPR: partial reduction in size of visible disease in some or all areas without any increase in visible disease.
Overall Survival (OS)	Up to 6 months	OS is defined as the time from the date of advanced disease diagnosis until the date of death. Participants for whom a date of death has not been identified, will be censored at the date of last contact available.
Real-world Disease Control Rate (rwDCR)	Up to 6 months	rwDCR is defined as the percentage of participants who have a rwCR, rwPR, or real-world stable disease (rwSD) assessment during the course of a line of therapy, among all participants in that cohort. rwCR: complete resolution of disease, rwPR: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease, rwSD: no change in overall size of visible disease, or mixed response (some lesions increased, some lesions decreased).

Trial Locations

Locations (30)

CHU Strasbourg - Nouvel Hopital Civil; 🇫🇷 Strasbourg, Rhone, France

University Health Network Princess Margaret Cancer Research Tower (PMCRT) The MaRS Centre, East Tower; 🇨🇦 Toronto, Ontario, Canada

Centre Hospitalier de Saint-Quentin; 🇫🇷 Saint-Quentin cedex, Aisne, France

Institut Bergonie; 🇫🇷 Bordeaux cedex, Gironde, France

CHU Poitiers - Hopital la Miletrie; 🇫🇷 Poitiers, Vienne, France

Centre Georges Francois Leclerc; 🇫🇷 Dijon Cedex, Cote-d'Or, France

Grand River Hospital; 🇨🇦 Kitchener, Ontario, Canada

Hopital Nord - CHU Marseille; 🇫🇷 Marseille, Bouches-du-Rhone, France

CHU Brest - Hopital Morvan; 🇫🇷 Brest Cedex, Finistere, France

Centre Leon Berard; 🇫🇷 Lyon, Rhone, France

Ottawa Hospital Research Institute.; 🇨🇦 Ottawa, Ontario, Canada

Hopital Larrey; 🇫🇷 Toulouse, Haute Garonne, France

Centre Hospitalier de la Region d'Annecy; 🇫🇷 Pringy cedex, Haute Savoie, France

Hopital Tenon; 🇫🇷 Paris, France

Institut Curie - site de Paris; 🇫🇷 Paris Cedex 05, Paris, France

William Osler Health System; 🇨🇦 Brampton, Ontario, Canada

CHU Clermont-Ferrand; 🇫🇷 Clermont Ferrand cedex, Puy De Dome, France

Hopital Albert Calmette - CHU Lille; 🇫🇷 Lille Cedex, Nord, France

Hospices Civils de Lyon; 🇫🇷 Lyon, Rhone, France

Centre Hospitalier Intercommunal de Creteil; 🇫🇷 Creteil Cedex, Val De Marne, France

Centre Hospitalier Regional de la Reunion; 🇫🇷 Saint-Pierre, Seine Saint Denis, France

Hospital Center Henri Duffaut; 🇫🇷 Avignon, Vaculuse, France

Centre Francois Baclesse; 🇫🇷 Caen Cedex 05, Calvados, France

Hopital de Versailles; 🇫🇷 Versailles, Yvelines, France

Pamela Youde Nethersole Eastern Hospital; 🇭🇰 Hong Kong, Hong Kong

Queen Elizabeth Hospital; 🇭🇰 Hong Kong, Hong Kong

Princess Margaret Hospital; 🇭🇰 Hong Kong, Hong Kong

Tuen Mun Hospital; 🇭🇰 Hong Kong, Hong Kong

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong