A Chart Review Study of Adults With Advanced NSCLC (EXTRACT)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05207423 |
|
Recruitment Status :
Completed
First Posted : January 26, 2022
Last Update Posted : February 28, 2023
|
Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease |
|---|
| Non-small Cell Lung Cancer (NSCLC) |
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 Type : | Observational |
| Actual Enrollment : | 179 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Patterns of Care and Clinical Outcomes of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations |
| Actual Study Start Date : | October 3, 2022 |
| Actual Primary Completion Date : | February 13, 2023 |
| Actual Study Completion Date : | February 13, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Group/Cohort |
|---|
|
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.
|
Primary Outcome Measures :
- 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Criteria
Inclusion Criteria
- 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.
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05207423
Locations
Show 30 study locations
Sponsors and Collaborators
Takeda
Investigators
| Study Director: | Study Director | Takeda |
Additional Information:
| Responsible Party: | Takeda |
| ClinicalTrials.gov Identifier: | NCT05207423 |
| Other Study ID Numbers: |
TAK-788-4002 |
| First Posted: | January 26, 2022 Key Record Dates |
| Last Update Posted: | February 28, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (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. |
| URL: | https://vivli.org/ourmember/takeda/ |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Takeda:
|
Drug Therapy Retrospective Chart review NSCLC |
Mobocertinib EGFR exon 20 NSCLC Real World |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |