A Chart Review Study of Adults With Advanced NSCLC

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

— EXTRACT  

Official title:

Patterns of Care and Clinical Outcomes of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05207423
• Other study ID #: TAK-788-4002
• Status: Completed
• Start date: October 3, 2022
• Est. completion date: February 13, 2023

Study information

• Verified date: February 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: February 13, 2023
• Est. primary completion date: February 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Locations

Country	Name	City	State
Canada	William Osler Health System	Brampton	Ontario
Canada	Grand River Hospital	Kitchener	Ontario
Canada	Ottawa Hospital Research Institute.	Ottawa	Ontario
Canada	University Health Network Princess Margaret Cancer Research Tower (PMCRT) The MaRS Centre, East Tower	Toronto	Ontario
France	Hospital Center Henri Duffaut	Avignon	Vaculuse
France	Institut Bergonie	Bordeaux cedex	Gironde
France	CHU Brest - Hopital Morvan	Brest Cedex	Finistere
France	Centre Francois Baclesse	Caen Cedex 05	Calvados
France	CHU Clermont-Ferrand	Clermont Ferrand cedex	Puy De Dome
France	Centre Hospitalier Intercommunal de Creteil	Creteil Cedex	Val De Marne
France	Centre Georges Francois Leclerc	Dijon Cedex	Cote-d'Or
France	Hopital Albert Calmette - CHU Lille	Lille Cedex	Nord
France	Centre Leon Berard	Lyon	Rhone
France	Hospices Civils de Lyon	Lyon	Rhone
France	Hopital Nord - CHU Marseille	Marseille	Bouches-du-Rhone
France	Hopital Tenon	Paris
France	Institut Curie - site de Paris	Paris Cedex 05	Paris
France	CHU Poitiers - Hopital la Miletrie	Poitiers	Vienne
France	Centre Hospitalier de la Region d'Annecy	Pringy cedex	Haute Savoie
France	Centre Hospitalier Regional de la Reunion	Saint-Pierre	Seine Saint Denis
France	Centre Hospitalier de Saint-Quentin	Saint-Quentin cedex	Aisne
France	CHU Strasbourg - Nouvel Hopital Civil	Strasbourg	Rhone
France	Hopital Larrey	Toulouse	Haute Garonne
France	Hopital de Versailles	Versailles	Yvelines
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Princess Margaret Hospital	Hong Kong
Hong Kong	Queen Elizabeth Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Tuen Mun Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Canada,  France,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real-world Progression Free Survival (rwPFS)	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.	Up to 6 months
Primary	Real-world Overall Response Rate (rwORR)	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.	Up to 6 months
Primary	Confirmed Real-world Overall Response Rate (rwCORR)	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.	Up to 6 months
Primary	Real-world Duration of Response (rwDOR)	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.	Up to 6 months
Primary	Real-world Disease Control Rate (rwDCR)	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).	Up to 6 months
Primary	Overall Survival (OS)	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.	Up to 6 months
Primary	Real-world Time to Treatment Discontinuation (rwTTD)	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.	Up to 6 months

External Links

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