Clinical trial · Observational
A Study to Learn About the Tests Looking for a Gene Mutation in Adults With Lung Cancer in China (ELEGANT)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business reason, unrelated to product safety
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort 1: Participants With Positive EGFR ex20ins Detection
- description
- Participants with NSCLC having positive EGFR ex20ins detected by NGS were observed retrospectively for three years prior to leading site initiation.
- interventionNames
- Other: No Intervention
- label
- Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection
- description
- Participants with NSCLC having positive and negative EGFR ex20ins NGS testing results were observed retrospectively for three years prior to leading site initiation.
- interventionNames
- Other: No Intervention
Primary outcomes (3)
- measure
- Cohort 2: Prevalence of EGFR ex20ins in Chinese Participants With Locally Advanced or Metastatic NSCLC
- timeFrame
- Up to 3 years prior to leading site initiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: 1\. Incomplete information, including key demographic characteristics, clinicopathological characteristics, and genetic testing information.
References
Publications (0)
Data not yet available