Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study.
The main objective of this study is to determine the prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB) non-squamous NSCLC as there are limited data on its prevalence in this patient population.
This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study. Eligible patients should have availability of formalin-fixed paraffin-embedded (FFPE) specimen(s) to be primarily tested for EGFRm at validated local laboratories or a central laboratory. The informed consent will be obtained from the patients during their routine clinical care visit before data are collected from the medical records. The data on socio-demographics, tumour staging, histology, surgical management, and neoadjuvant therapies will be collected from available medical records at the treating facility by the investigator. If PD-L1 testing is conducted as part of routine clinical care, the available results will be recorded. Patients will be followed prospectively and follow-up will be considered as complete once EGFRm status of the patient's tumour sample is known and any planned adjuvant therapy has been recorded.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Overall proportion of patients with EGFRm | Prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC followed by Proportion of EGFRm by the following subgroup: o Histology (adenocarcinoma, bronchiole-alveolar, large cell carcinoma, mixed, other, unknown) | 3 month |
| Proportion of EGFRm in Pathologic Stage | Prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC followed by Proportion of EGFRm by the following subgroup: o Pathologic stage (IA, IB, IIA, IIB, IIIA, IIIB with lymph node metastasis status [N0, N1, and N2])b | 3 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with the EGFRm types | Proportion of patients with the following EGFRm types:
| 3 Month |
| Proportion of patients who were prescribed modalities |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a tumour PD-L1 IHC test result | Proportion of patients with PD-L1 positivity at various cut-points (<1%, ≥1%, ≥50%) grouped according to:
| 3 Month |
Inclusion Criteria:
Exclusion Criteria:
Patients who fulfil any of the following exclusion criteria will not be eligible for the study:
Not provided
Not provided
Not provided
patients who have stage IA to IIIB NSCLC with non-squamous histology and who have undergone surgical resection of tumour up to 6 weeks prior to enrolment
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Rosario - Santa Fe | Argentina | S2002RE | Argentina | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39772802 | Derived | Batra U, Prabhash K, Noronha V, Deshpande R, Khurana S, Bhat GM, Mistry R, Agarwala V, Rajpurohit S, Poladia B, Sharma M, Banday SZ. Prevalence of EGFR Mutations in Patients With Resected Stage I to III Nonsquamous Non-Small Cell Lung Cancer: Results of India Cohort. JCO Glob Oncol. 2025 Jan;11:e2400353. doi: 10.1200/GO-24-00353. Epub 2025 Jan 7. | |
| 38880172 |
| Label | URL |
|---|---|
| Redacted CSR synopsis | View source |
Not provided
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Not provided
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Not provided
Not provided
Not provided
Not provided
Proportion of patients who were prescribed these modalities:
|
| 3 Month |
| Buenos Aires |
| 1415 |
| Argentina |
| Research Site | Santiago | 13123 | Chile |
| Research Site | Santiago | 7500713 | Chile |
| Research Site | Montería -Cordoba | Colombia | 230002 | Colombia |
| Research Site | Bogotá | 110111 | Colombia |
| Research Site | San José | 10103 | Costa Rica |
| Research Site | Santo Domingo | 10105 | Dominican Republic |
| Research Site | Alexandria | Egypt |
| Research Site | Cairo | Egypt |
| Research Site | Tanta | Egypt |
| Research Site | Kāshmir | India |
| Research Site | Kolkata | India |
| Research Site | Mumbai | India |
| Research Site | New Delhi | India |
| Research Site | Kuwait City | Kuwait |
| Research Site | Mexico City | Mexico City | 6720 | Mexico |
| Research Site | Guadalajara | 64700 | Mexico |
| Research Site | Monterrey | 44260 | Mexico |
| Research Site | Lima | 15036 | Peru |
| Research Site | Lima | 15074 | Peru |
| Research Site | City of Taguig | Philippines | Philippines |
| Research Site | Iliolo City | Philippines | Philippines |
| Research Site | Cebu City | Philippines |
| Research Site | Makati | Philippines |
| Research Site | Manila | Philippines |
| Research Site | Quezon City | Philippines |
| Research Site | Singapore | Singapore |
| Research Site | Muang | Thailand | Thailand |
| Research Site | Bangkok | Thailand |
| Research Site | Ankara | Turkey (Türkiye) |
| Research Site | Hanoi | 100000 | Vietnam |
| Research Site | Ho Chi Minh City | 70000 | Vietnam |
| Soo RA, Reungwetwattana T, Perroud HA, Batra U, Kilickap S, Tejado Gallegos LF, Donner N, Alsayed M, Huggenberger R, Van Tu D. Prevalence of EGFR Mutations in Patients With Resected Stages I to III NSCLC: Results From the EARLY-EGFR Study. J Thorac Oncol. 2024 Oct;19(10):1449-1459. doi: 10.1016/j.jtho.2024.06.008. Epub 2024 Jun 14. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided