Non-small Cell Lung Cancer (NSCLC)ELEGANTNCT05737849
A Study to Learn About the Tests Looking for a Gene Mutation in Adults With Lung Cancer in China (ELEGANT)
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Takeda at 1 site in China.
Trial summary
The main aim of this study is to examine the percentage of people with lung cancer who carry a certain gene mutation (epidermal growth factor receptor exon 20 insertions - EGFR ex20ins) and their frequency in Chinese participants with Non-small cell lung cancer (NSCLC) after having been tested for the gene mutation. 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
- 0 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2024to 30 Dec 2024
- 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: Cohort 1: Participants with locally advanced or metastatic NSCLC who received NGS testing and have EGFR ex20ins positive results. Cohort 2: Participants with locally advanced or metastatic NSCLC who received NGS testing.
Who may be able to join
- Cohort 1 and 2:
- 1. Participants with a diagnosis of locally advanced or metastatic NSCLC, clinical staging of IIIB-IV.
- Cohort-1:
- 1. Participants who have received NGS testing and have EGFR ex20ins positive result.
- Cohort-2:
- 1. Participants who have received NGS testing
Who cannot join
- 1. Incomplete information, including key demographic characteristics, clinicopathological characteristics, and genetic testing information.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College
Beijing, 100021
About this study
Official title: To Investigate EGFR Exon20 Insertion Mutation Testing Methodologies, Clinicopathological Characteristics and Molecular Epidemiology in Chinese Patients With Advanced NSCLC: a Nationwide Multicentre Real-world Registry Study
The main aim of this study is to examine the percentage of people with lung cancer who carry a certain gene mutation (epidermal growth factor receptor exon 20 insertions - EGFR ex20ins) and their frequency in Chinese participants with Non-small cell lung cancer (NSCLC) after having been tested for the gene mutation.
Data from the participant's electronic medical records at the hospital will be collected.
Read the detailed description
This is a non-interventional, retrospective, observational study of the Chinese participants with locally advanced or metastatic NSCLC with EGFR ex20ins mutation. The primary objective of this study is to explore the prevalence of EGFR ex20ins, subtypes of EGFR ex20ins and their frequency in Chinese participants with locally advanced or metastatic NSCLC.
The study will enroll approximately 10800 patients. Participants will be enrolled in the following two cohorts:
- Cohort 1: Participants With Positive EGFR ex20ins Detection
- Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection
The data will be collected retrospectively using the participant electronic medical records and next-generation gene sequencing (NGS)/polymerase chain reaction (PCR) kit instructions.
This multi-center trial will be conducted at 15 sites across China. The overall time to participate and data collection will be approximately 12 months.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- No Intervention
- Keywords
- Drug Therapy, EGFR exon20 insertion mutation
- 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.
No InterventionOther
As this is an observational study, no intervention will be administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Participants With Positive EGFR ex20ins Detection | Participants with NSCLC having positive EGFR ex20ins detected by NGS were observed retrospectively for three years prior to leading site initiation. Receives: Other: No Intervention | |
| Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection | Participants with NSCLC having positive and negative EGFR ex20ins NGS testing results were observed retrospectively for three years prior to leading site initiation. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 2: Prevalence of EGFR ex20ins in Chinese Participants With Locally Advanced or Metastatic NSCLC
The prevalence of EGFR ex20ins will be reported for participants with locally advanced or metastatic NSCLC.
Measured: Up to 3 years prior to leading site initiation
Cohort 1 and 2: Number of EGFR ex20ins Subtypes in Chinese Participants With Locally Advanced or Metastatic NSCLC
EGFR ex20ins subtype is defined by insertion or duplication mutation occurred in amino acids (AA) 761 to AA775 of EGFR gene. The number of EGFR ex20ins subtypes will be reported.
Measured: Up to 3 years prior to leading site initiation
Cohort 1 and 2: Frequency of Each EGFR ex20ins Subtype in Chinese Participants With Locally Advanced or Metastatic NSCLC
The frequency of each EGFR ex20ins subtype will be reported.
Measured: Up to 3 years prior to leading site initiation
Secondary outcomes (11)
Cohort 1 and 2: Percentage of Theoretically Underdiagnosed EGFR ex20ins Mutation by Different PCR Kits Based on NGS Real-world Database
The theoretically underdiagnosed rate about EGFR ex20ins detection by different PCR kits available in China will be reported.
Measured: Up to 3 years prior to leading site initiation
Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Demographic Characteristics
Demographic characteristics include age, gender, smoking history and family history for malignancies.
Measured: Up to 3 years prior to leading site initiation
Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Clinical Stages of Lung Cancer at the Time of NGS Testing
Number of EGFR ex20ins positive participants with the clinical stages of cancer IIIB, IIIC, IV will be evaluated using the international association for the study of lung cancer eighth edition of the tumor, nodes, and metastases (TNM) classification for staging criteria.
Measured: Up to 3 years prior to leading site initiation
Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Cytology or Histology at the Time of NGS Testing
Number of EGFR ex20ins positive participants with adenocarcinoma, squamous cell carcinoma, mixed, or other carcinomas will be evaluated.
Measured: Up to 3 years prior to leading site initiation
Cohort 1 and 2: Site of Metastasis at the Time of NGS Testing
Site of metastasis at the time of NGS testing will be reported.
Measured: Up to 3 years prior to leading site initiation
Cohort 1 and 2: Number and Kinds of Co-occurring Mutations of EGFR ex20ins at Baseline in Positive Participants Detected by NGS Testing
The number and kinds of co-occurring mutations at baseline will be reported. The baseline is defined as treatment naive before NGS testing.
Measured: Baseline (prior to NGS testing)
Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Demographic Characteristics
Demographic characteristics include age, gender, smoking history and family history for malignancies.
Measured: Up to 3 years prior to leading site initiation
Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Clinical Stages of Lung Cancer at the Time of NGS Testing
Number of EGFR ex20ins positive participants, participants with common EGFR mutations and participants with EGFR wild type with the clinical stages of cancer IIIB, IIIC, IV will be evaluated using the international association for the study of lung cancer eighth edition of the TNM classification for staging criteria.
Measured: Up to 3 years prior to leading site initiation
Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Cytology or Histology at the Time of NGS Testing
Number of EGFR ex20ins positive participants, participants with common EGFR mutations and participants with EGFR wild type with adenocarcinoma, squamous cell carcinoma, mixed, or other carcinomas will be evaluated.
Measured: Up to 3 years prior to leading site initiation
Cohort 2: Site of Metastasis at the Time of NGS Testing
Site of metastasis at the time of NGS testing will be reported.
Measured: Up to 3 years prior to leading site initiation
Cohort 2: Number and Kinds of Co-occurring Mutations at Baseline in EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type Detected by NGS Testing
The number and kinds of co-occurring mutations at baseline will be reported. The baseline is defined as treatment naive before NGS testing.
Measured: Baseline (prior to NGS testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start30 Jan 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Why it stopped: Business reason, unrelated to product safety
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
- 0 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
- NCT05737849
- Sponsor's protocol ID
- TAK-788-4004
- Acronym
- ELEGANT
- Status last verified
- Oct 2023
- First submitted
- 10 Feb 2023
- Last updated
- 23 Oct 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate EGFR Exon20 Insertion Mutation Testing Methodologies, Clinicopathological Characteristics and Molecular Epidemiology in Chinese Patients With Advanced NSCLC: a Nationwide Multicentre Real-world Registry Study
- ClinicalTrials.gov ID
- NCT05737849
- Acronym / sponsor ID
- ELEGANT / TAK-788-4004
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Drug Therapy, EGFR exon20 insertion mutation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business reason, unrelated to product safety
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Feb 2023 (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 of this study is to examine the percentage of people with lung cancer who carry a certain gene mutation (epidermal growth factor receptor exon 20 insertions - EGFR ex20ins) and their frequency in Chinese participants with Non-small cell lung cancer (NSCLC) after having been tested for the gene mutation.
Data from the participant's electronic medical records at the hospital will be collected.
Detailed description
This is a non-interventional, retrospective, observational study of the Chinese participants with locally advanced or metastatic NSCLC with EGFR ex20ins mutation. The primary objective of this study is to explore the prevalence of EGFR ex20ins, subtypes of EGFR ex20ins and their frequency in Chinese participants with locally advanced or metastatic NSCLC.
The study will enroll approximately 10800 patients. Participants will be enrolled in the following two cohorts:
- Cohort 1: Participants With Positive EGFR ex20ins Detection
- Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection
The data will be collected retrospectively using the participant electronic medical records and next-generation gene sequencing (NGS)/polymerase chain reaction (PCR) kit instructions.
This multi-center trial will be conducted at 15 sites across China. The overall time to participate and data collection will be approximately 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Participants With Positive EGFR ex20ins Detection | – | Other: No InterventionParticipants with NSCLC having positive EGFR ex20ins detected by NGS were observed retrospectively for three years prior to leading site initiation. |
| Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection | – | Other: No InterventionParticipants with NSCLC having positive and negative EGFR ex20ins NGS testing results were observed retrospectively for three years prior to leading site initiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort 1: Participants with locally advanced or metastatic NSCLC who received NGS testing and have EGFR ex20ins positive results. Cohort 2: Participants with locally advanced or metastatic NSCLC who received NGS testing.
Key inclusion criteria (6 listed)
- 1. Participants with a diagnosis of locally advanced or metastatic NSCLC, clinical staging of IIIB-IV.
- 1. Participants who have received NGS testing and have EGFR ex20ins positive result.
- 1. Participants who have received NGS testing
Key exclusion criteria (1 listed)
- 1. Incomplete information, including key demographic characteristics, clinicopathological characteristics, and genetic testing information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionAs this is an observational study, no intervention will be administered in this study. | Other | Cohort 1: Participants With Positive EGFR ex20ins Detection, Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection |
Primary outcome
Cohort 2: Prevalence of EGFR ex20ins in Chinese Participants With Locally Advanced or Metastatic NSCLC
Time frame: Up to 3 years prior to leading site initiation
The prevalence of EGFR ex20ins will be reported for participants with locally advanced or metastatic NSCLC.
Cohort 1 and 2: Number of EGFR ex20ins Subtypes in Chinese Participants With Locally Advanced or Metastatic NSCLC
Time frame: Up to 3 years prior to leading site initiation
EGFR ex20ins subtype is defined by insertion or duplication mutation occurred in amino acids (AA) 761 to AA775 of EGFR gene. The number of EGFR ex20ins subtypes will be reported.
Cohort 1 and 2: Frequency of Each EGFR ex20ins Subtype in Chinese Participants With Locally Advanced or Metastatic NSCLC
Time frame: Up to 3 years prior to leading site initiation
The frequency of each EGFR ex20ins subtype will be reported.
11 secondary outcomes
Cohort 1 and 2: Percentage of Theoretically Underdiagnosed EGFR ex20ins Mutation by Different PCR Kits Based on NGS Real-world Database
Time frame: Up to 3 years prior to leading site initiation
Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Demographic Characteristics
Time frame: Up to 3 years prior to leading site initiation
Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Clinical Stages of Lung Cancer at the Time of NGS Testing
Time frame: Up to 3 years prior to leading site initiation
Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Cytology or Histology at the Time of NGS Testing
Time frame: Up to 3 years prior to leading site initiation
Cohort 1 and 2: Site of Metastasis at the Time of NGS Testing
Time frame: Up to 3 years prior to leading site initiation
Cohort 1 and 2: Number and Kinds of Co-occurring Mutations of EGFR ex20ins at Baseline in Positive Participants Detected by NGS Testing
Time frame: Baseline (prior to NGS testing)
Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Demographic Characteristics
Time frame: Up to 3 years prior to leading site initiation
Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Clinical Stages of Lung Cancer at the Time of NGS Testing
Time frame: Up to 3 years prior to leading site initiation
Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Cytology or Histology at the Time of NGS Testing
Time frame: Up to 3 years prior to leading site initiation
Cohort 2: Site of Metastasis at the Time of NGS Testing
Time frame: Up to 3 years prior to leading site initiation
Cohort 2: Number and Kinds of Co-occurring Mutations at Baseline in EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type Detected by NGS Testing
Time frame: Baseline (prior to NGS testing)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- To obtain more information on the study, click here/on this linkLink 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
1 site 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 1 site in China.
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 6 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: withdrawn, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 was withdrawn before enrolling participants, so there are no results.
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?
Cohort 2: Prevalence of EGFR ex20ins in Chinese Participants With Locally Advanced or Metastatic NSCLC (time frame: Up to 3 years prior to leading site initiation). The study lists 3 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 23 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.