A Chart Review Study of Adults With Advanced NSCLC
EXTRACT
Patterns of Care and Clinical Outcomes of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
1 other identifier
observational
179
3 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2022
Shorter than P25 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2022
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedStudy Start
First participant enrolled
October 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2023
CompletedFebruary 28, 2023
February 1, 2023
4 months
January 12, 2022
February 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
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
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
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
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
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
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
Study Arms (1)
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.
Eligibility Criteria
Participants who were diagnosed with advanced NSCLC with EGFR ex20ins mutations and who were treated at the participating sites will be included until end of follow-up or death, whichever occurs first.
You may qualify if:
- 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.
- Followed-up at the site between 01 January 2017 and 30 November 2021 for his/her advanced NSCLC, irrespective of their current survival status.
You may not qualify if:
- \. Participants whose investigator has access to fewer than two registered visits for his/her advanced NSCLC between 01 January 2017 and 30 November 2021.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (30)
William Osler Health System
Brampton, Ontario, L6R 3J7, Canada
Grand River Hospital
Kitchener, Ontario, N2G 1G3, Canada
Ottawa Hospital Research Institute.
Ottawa, Ontario, K1H 8L6, Canada
University Health Network Princess Margaret Cancer Research Tower (PMCRT) The MaRS Centre, East Tower
Toronto, Ontario, M5G 1L7, Canada
Centre Hospitalier de Saint-Quentin
Saint-Quentin, Aisne, 2321, France
Hopital Nord - CHU Marseille
Marseille, Bouches-du-Rhone, 13015, France
Centre Francois Baclesse
Caen, Calvados, 14076, France
Centre Georges Francois Leclerc
Dijon, Cote-d'Or, 21034, France
CHU Brest - Hopital Morvan
Brest, Finistere, 29200, France
Institut Bergonie
Bordeaux, Gironde, 33076, France
Hopital Larrey
Toulouse, Haute Garonne, 31000, France
Centre Hospitalier de la Region d'Annecy
Pringy, Haute Savoie, 74374, France
Hopital Albert Calmette - CHU Lille
Lille, Nord, 59037, France
Institut Curie - site de Paris
Paris, Paris, 75005, France
CHU Clermont-Ferrand
Clermont-Ferrand, Puy De Dome, 63003, France
Centre Leon Berard
Lyon, Rhone, 69008, France
Hospices Civils de Lyon
Lyon, Rhone, 69677, France
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, Rhone, 67091, France
Centre Hospitalier Regional de la Reunion
Saint-Pierre, Seine Saint Denis, 97400, France
Hospital Center Henri Duffaut
Avignon, Vaculuse, 84000, France
Centre Hospitalier Intercommunal de Creteil
Créteil, Val De Marne, 94010, France
CHU Poitiers - Hopital la Miletrie
Poitiers, Vienne, 86021, France
Hopital de Versailles
Versailles, Yvelines, 78000, France
Hopital Tenon
Paris, 75020, France
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, Hong Kong
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2022
First Posted
January 26, 2022
Study Start
October 3, 2022
Primary Completion
February 13, 2023
Study Completion
February 13, 2023
Last Updated
February 28, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.