Multicountry Study to assess EGFR Mutations in Patients With Non-small Cell Lung Cancer
- Conditions
- Health Condition 1: C342- Malignant neoplasm of middle lobe,bronchus or lung
- Registration Number
- CTRI/2021/07/035023
- Lead Sponsor
- AstraZeneca Pharma India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Adult male or female patients =18 years old or ‘adults’ according to age of majority as
defined by the local regulations
2. Patient or next of kin/legal representative is willing and able to provide informed
consent according to the local regulations, where applicable
3. Patients with stage IA to IIIB (on the basis of pathologic criteria) NSCLC with
adenocarcinoma, or mixed histology with an adenocarcinoma component who have
undergone surgical resection of the tumour during the preceding 6 weeksa
4. Availability of FFPE tissue specimen suitable for EGFRm testing (either the primary
diagnostic sample or the surgically resected tumour specimen)
5. Availability of medical records at the participating site detailing the initial diagnosis,
staging, and surgical management of NSCLC
1. Histology of the tumour is considered not to be of primary lung in origin
2. Histology is pure squamous cell carcinoma, pure small cell carcinoma, or large cell
carcinoma origin lacking any immunohistochemistry evidence of adenocarcinoma
differentiation.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall proportion of patients with EGFRm <br/ ><br>• Proportion of EGFRm by the following subgroups: <br/ ><br>Histology, <br/ ><br>Pathologic stage, Age, Gender <br/ ><br>Tobacco smoking, Ethnicity, Family history of lung cancer in first-degree relative, Geographical location.Timepoint: One day
- Secondary Outcome Measures
Name Time Method Proportion of patients with the following EGFRm types: <br/ ><br>Exon19 deletions, Exon21 L858R <br/ ><br>o Exon20 T790M <br/ ><br>o Others (compound mutations, uncommon mutations [including G719X, L861Q, <br/ ><br>S768I, and 20 insertions]) <br/ ><br>Proportion of patients who were prescribed these modalities: <br/ ><br>Only surgical resection, Surgical resection and radiotherapy, Surgical resection and systemic therapy (neoadjuvant and/or adjuvant),Surgical resection, radiotherapy and systemic therapy (neoadjuvant and/or adjuvant)Timepoint: One day