Non-small Cell Lung Cancer (NSCLC)EXTRACTNCT05207423
A Chart Review Study of Adults With Advanced NSCLC
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Takeda at 30 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- How many people
- 179 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 3 Oct 2022to 13 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
France20 sites
Hospital Center Henri Duffaut
Avignon, Vaculuse, 84000
Institut Bergonie
Bordeaux, Gironde, 33076
CHU Brest - Hopital Morvan
Brest, Finistere, 29200
Centre Francois Baclesse
Caen, Calvados, 14076
CHU Clermont-Ferrand
Clermont-Ferrand, Puy De Dome, 63003
Centre Hospitalier Intercommunal de Creteil
Créteil, Val De Marne, 94010
Centre Georges Francois Leclerc
Dijon, Cote-d'Or, 21034
Hopital Albert Calmette - CHU Lille
Lille, Nord, 59037
Centre Leon Berard
Lyon, Rhone, 69008
Hospices Civils de Lyon
Lyon, Rhone, 69677
Hopital Nord - CHU Marseille
Marseille, Bouches-du-Rhone, 13015
Institut Curie - site de Paris
Paris, Paris, 75005
Hopital Tenon
Paris, 75020
CHU Poitiers - Hopital la Miletrie
Poitiers, Vienne, 86021
Centre Hospitalier de la Region d'Annecy
Pringy, Haute Savoie, 74374
Centre Hospitalier Regional de la Reunion
Saint-Pierre, Seine Saint Denis, 97400
Centre Hospitalier de Saint-Quentin
Saint-Quentin, Aisne, 2321
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, Rhone, 67091
Hopital Larrey
Toulouse, Haute Garonne, 31000
Hopital de Versailles
Versailles, Yvelines, 78000
Hong Kong6 sites
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Prince of Wales Hospital
Hong Kong
Princess Margaret Hospital
Hong Kong
Queen Elizabeth Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Tuen Mun Hospital
Hong Kong
Canada4 sites
William Osler Health System
Brampton, Ontario, L6R 3J7
Grand River Hospital
Kitchener, Ontario, N2G 1G3
Ottawa Hospital Research Institute.
Ottawa, Ontario, K1H 8L6
University Health Network Princess Margaret Cancer Research Tower (PMCRT) The MaRS Centre, East Tower
Toronto, Ontario, M5G 1L7
About this study
Official title: Patterns of Care and Clinical Outcomes of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Drug Therapy, Retrospective, Chart review, NSCLC, Mobocertinib, EGFR exon 20 NSCLC, Real World
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start3 Oct 2022
- Primary completion13 Feb 2023
- Study completion13 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207423
- Sponsor's protocol ID
- TAK-788-4002
- Acronym
- EXTRACT
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Care and Clinical Outcomes of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
- ClinicalTrials.gov ID
- NCT05207423
- Acronym / sponsor ID
- EXTRACT / TAK-788-4002
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Drug Therapy, Retrospective, Chart review, NSCLC, Mobocertinib, EGFR exon 20 NSCLC, Real World
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 13 Feb 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Real-world Progression Free Survival (rwPFS)
Time frame: 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 Overall Response Rate (rwORR)
Time frame: 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.
Confirmed Real-world Overall Response Rate (rwCORR)
Time frame: 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.
Real-world Duration of Response (rwDOR)
Time frame: 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 Disease Control Rate (rwDCR)
Time frame: 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).
Overall Survival (OS)
Time frame: 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 Time to Treatment Discontinuation (rwTTD)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Takeda at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France, Hong Kong, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world Progression Free Survival (rwPFS) (time frame: Up to 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.