Non-small Cell Lung Cancer (NSCLC)ermEX-20NCT05419700
A Spanish Medical Record Review of Clinical Characteristics and Outcomes in Non-small Cell Lung Cancer Participants With EGFR Exon 20 Insertion
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Takeda at 15 sites in Spain.
Trial summary
The main aim is to evaluate sociodemographic and clinical characteristics of advanced Non-Small Cell Lung Cancer (NSCLC) in adults participants with epidermal growth factor receptor (EGFR) exon 20 insertions mutations during the 5 years before data extraction date (from 1-Jan-2017 to 1-Jan-2022). 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
- 76 participants
- Where
- 15 sitesSpain
- Study dates
- 5 Aug 2022to 1 Sep 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: Adult participants with advanced NSCLC with EGFR exon 20 insertion and who received treatment during the last 5 years at participating sites will be included in this study.
Who may be able to join
- Participants with a pathologically and/or cytologically confirmed diagnosis of advanced stage NSCLC (International Classification of Disease, 10th revision [ICD-10] C34.x), either primary, advanced or after relapse of initial non-metastatic disease, evaluated and treated during the last five years prior data extraction date from 1-Jan-2017 to 1-Jan-2022.
- Participants with detection of an EGFR exon 20 insertion mutation, at any point.
- Has documentation available for at least 2 visits since the initiation of the last treatment within the last five years (1-January-2017 to 1-January-2022).
Who cannot join
- 1. Participants do not meet any of the inclusion criteria.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Complejo Hospitalario Universitario A Coruna (CHUAC)
A Coruña, Galicia, 15006
Hospital General Universitario de Alicante
Alicante, Valencia, 03010
ICO Badalona. Hospital Universitario Germans Trias i Pujol
Badalona, Catalonia, 8916
Hospital Clinicde Barcelona
Barcelona, Catalonia, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004
ICO Girona. Hospital Universitario Dr. Josep Trueta
Girona, Catalonia, 17007
Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario Puerta de Hierro
Madrid, Madrid, 28222
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010
Hospital Universitario de Navarra (HUN)
Pamplona, Navarre, 31008
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, Galicia, 15706
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
Hospital Universitari i Politecnic la Fe
Valencia, Valencia, 46026
About this study
Official title: Patient Characteristics, Treatment Patterns and Outcomes of Advanced Non-small Cell Lung Cancer Patients With EGFR Exon 20 Insertion Mutations: A Non-interventional Retrospective Medical Chart Review in Spain
The main aim is to evaluate sociodemographic and clinical characteristics of advanced Non-Small Cell Lung Cancer (NSCLC) in adults participants with epidermal growth factor receptor (EGFR) exon 20 insertions mutations during the 5 years before data extraction date (from 1-Jan-2017 to 1-Jan-2022).
Participants will not receive any drug. This study will only collect the data from the medical records via chart review.
Read the detailed description
This is an observational, non-interventional, retrospective study in participants with NSCLC with EGFR exon 20 insertions mutations. This study will assess the sociodemographic and clinical characteristics of advanced NSCLC participants.
The study will enroll approximately 60 participants. Participants who were evaluated and treated at the participating sites between 01 January 2017 and 30 September 2021 will be included. The data will be collected from the medical record of participants via medical chart review. All the participants will be assigned to a single observational cohort:
- Participants With Advanced NSCLC with EGFR Exon 20 Insertions Mutations
This multi-center trial will be conducted in Spain. The overall duration of the study will be approximately 27 months.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Drug Therapy
- 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 Insertions Mutations | All participants diagnosed with advanced NSCLC with Epidermal growth factor receptor EGFR exon 20 insertion mutations will be enrolled in this study. All study data will be collected retrospectively from participants medical records via medical chart review. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Based on Type of EGFR Mutation
Percentage of participants will be reported based on type of EGFR mutation and its variant: EGFR exon 20 insertion or compound mutations.
Measured: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Secondary outcomes (10)
Overall Response Rate (ORR)
ORR is defined as the percentage of participants on a given treatment that have at least one partial remission (PR)/complete remission (CR) assessment determination within 3 months after initiation of treatment. CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. ORR will be assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Measured: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Progression-free Survival (PFS)
PFS is defined as the time from treatment start until disease progression (PD) or death. PD: defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions. PFS will be assessed by RECIST 1.1.
Measured: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Disease Control Rate (DCR)
DCR is defined as the percentage of participants on a given treatment that have at least one PR/CR/stable disease (SD) and no PD assessment determination within 3 months after treatment start. CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. SD: defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions. DCR will be assessed by RECIST 1.1.
Measured: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Time-to-treatment Failure (TTF)
TTF is defined as the time from treatment start until treatment discontinuation due to any reason including toxicity, PD, or death. PD: defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions. TTF will be assessed by RECIST 1.1.
Measured: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Overall Survival (OS)
OS is defined as the time from treatment start until death from any cause or the last follow-up. OS will be assessed by RECIST 1.1.
Measured: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Health Care Resources Utilization
Health care resources utilization including information related with direct costs (hospitalizations, tests, computed tomography [CT], positron emission tomography [PET], magnetic resonance imaging [MRI]) will be reported.
Measured: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Percentage of Participants With Grade 3 or Higher Treatment-related Adverse Events (AEs)
Treatment-related grade 3 or higher AE will be reported. Treatment-related AE grades will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Number of Participants who Experience at Least one Treatment-related AE
Participants with at least one treatment-related AE will be reported. An AE is defined as any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, a new disease or worsening in severity or frequency of a concomitant disease, temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product.
Measured: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Percentage of Participants who Experience at Least one AEs Leading to Treatment Discontinuation
Measured: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Percentage of Participants Based on Method of Molecular Testing for EGFR Mutation
Participants will be reported based on the method of molecular testing to analyze EGFR mutations (for example, polymerase chain reaction [PCR], PCR-reverse transcription [RT], Next-generation sequencing [NGS]).
Measured: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start5 Aug 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 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
- 76 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
- NCT05419700
- Sponsor's protocol ID
- TAK-788-5009
- Acronym
- ermEX-20
- Status last verified
- Sep 2023
- First submitted
- 10 Jun 2022
- Last updated
- 6 Sep 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 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Characteristics, Treatment Patterns and Outcomes of Advanced Non-small Cell Lung Cancer Patients With EGFR Exon 20 Insertion Mutations: A Non-interventional Retrospective Medical Chart Review in Spain
- ClinicalTrials.gov ID
- NCT05419700
- Acronym / sponsor ID
- ermEX-20 / TAK-788-5009
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 15 Jun 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 evaluate sociodemographic and clinical characteristics of advanced Non-Small Cell Lung Cancer (NSCLC) in adults participants with epidermal growth factor receptor (EGFR) exon 20 insertions mutations during the 5 years before data extraction date (from 1-Jan-2017 to 1-Jan-2022).
Participants will not receive any drug. This study will only collect the data from the medical records via chart review.
Detailed description
This is an observational, non-interventional, retrospective study in participants with NSCLC with EGFR exon 20 insertions mutations. This study will assess the sociodemographic and clinical characteristics of advanced NSCLC participants.
The study will enroll approximately 60 participants. Participants who were evaluated and treated at the participating sites between 01 January 2017 and 30 September 2021 will be included. The data will be collected from the medical record of participants via medical chart review. All the participants will be assigned to a single observational cohort:
- Participants With Advanced NSCLC with EGFR Exon 20 Insertions Mutations
This multi-center trial will be conducted in Spain. The overall duration of the study will be approximately 27 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Advanced NSCLC With EGFR Exon 20 Insertions Mutations | – | –All participants diagnosed with advanced NSCLC with Epidermal growth factor receptor EGFR exon 20 insertion mutations will be enrolled in this study. All study data will be collected retrospectively from participants medical records via medical chart review. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with advanced NSCLC with EGFR exon 20 insertion and who received treatment during the last 5 years at participating sites will be included in this study.
Key inclusion criteria (3 listed)
- Participants with a pathologically and/or cytologically confirmed diagnosis of advanced stage NSCLC (International Classification of Disease, 10th revision [ICD-10] C34.x), either primary, advanced or after relapse of initial non-metastatic disease, evaluated and treated during the last five years prior data extraction date from 1-Jan-2017 to 1-Jan-2022.
- Participants with detection of an EGFR exon 20 insertion mutation, at any point.
- Has documentation available for at least 2 visits since the initiation of the last treatment within the last five years (1-January-2017 to 1-January-2022).
Key exclusion criteria (1 listed)
- 1. Participants do not meet any of the inclusion criteria.
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
Percentage of Participants Based on Type of EGFR Mutation
Time frame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Percentage of participants will be reported based on type of EGFR mutation and its variant: EGFR exon 20 insertion or compound mutations.
10 secondary outcomes
Overall Response Rate (ORR)
Time frame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Progression-free Survival (PFS)
Time frame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Disease Control Rate (DCR)
Time frame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Time-to-treatment Failure (TTF)
Time frame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Overall Survival (OS)
Time frame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Health Care Resources Utilization
Time frame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Percentage of Participants With Grade 3 or Higher Treatment-related Adverse Events (AEs)
Time frame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Number of Participants who Experience at Least one Treatment-related AE
Time frame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Percentage of Participants who Experience at Least one AEs Leading to Treatment Discontinuation
Time frame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Percentage of Participants Based on Method of Molecular Testing for EGFR Mutation
Time frame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
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 6 Sep 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
15 sites in 1 country: 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 15 sites in Spain.
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 3 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain. 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?
Percentage of Participants Based on Type of EGFR Mutation (time frame: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)). 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 6 Sep 2023.