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Multicountry Study to assess EGFR Mutations in Patients With Non-small Cell Lung Cancer

A Multicountry, Multicentre, Non-interventional, Prospective Study to Determine the Prevalence of EGFR Mutations in Patients With Early-stage, Surgically Resected, Non-squamous, Non-small Cell Lung Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/07/035023
Enrollment
1500
Registered
2021-07-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C342- Malignant neoplasm of middle lobe,bronchus or lung

Interventions

None listed

Sponsors

AstraZeneca Pharma India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Overall proportion of patients with EGFRm • Proportion of EGFRm by the following subgroups: Histology, Pathologic stage, Age, Gender Tobacco smoking, Ethnicity, Family history of lung cancer in first-degree relative, Geographical location.Timepoint: One day

Secondary

MeasureTime frame
Proportion of patients with the following EGFRm types: Exon19 deletions, Exon21 L858R o Exon20 T790M o Others (compound mutations, uncommon mutations [including G719X, L861Q, S768I, and 20 insertions]) Proportion of patients who were prescribed these modalities: 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

Countries

India, Singapore, Taiwan

Contacts

Public ContactAmit Kumar

AstraZeneca Pharma India Ltd

ankush.vikasgaikwad@astrazeneca.com8451800603

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026