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.
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 Type
OBSERVATIONAL
As this is an observational study, no intervention will be administered in this study.
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, China
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 years prior to leading site initiation
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.
Time frame: 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.
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
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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.
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
Number of EGFR ex20ins positive participants with adenocarcinoma, squamous cell carcinoma, mixed, or other carcinomas will be evaluated.
Time frame: 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.
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
The number and kinds of co-occurring mutations at baseline will be reported. The baseline is defined as treatment naive before 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
Demographic characteristics include age, gender, smoking history and family history for malignancies.
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
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.
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
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.
Time frame: 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.
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
The number and kinds of co-occurring mutations at baseline will be reported. The baseline is defined as treatment naive before NGS testing.
Time frame: Baseline (prior to NGS testing)