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This is a prospective, observational, multicenter study, in which clinical and demographic data will be extracted from medical records. Convenience sample, with an estimated inclusion of 200 patients treated in seven participating centers.
Eligible tumors for this project will be from patients with advanced (unresectable or metastatic) non-small cell lung carcinoma, who will start first-line oncological treatment in one of the participating centers between 2025 and 2026 (between January 2025 and January 2026). Patients must be over 18 years old and data must be available in electronic medical records.
Medical records will be assessed to confirm patients' eligibility. Patients with localized disease amenable to local treatment, non-epithelial histology, small cell carcinoma and neuroendocrine tumor will not be eligible.
A survey will be designed targeting thoracic and generalist medical oncologists, aiming to understand the factors guiding the choice of first-line treatment regimens and to compare these insights with real-world data. The survey will be directed to Brazil, with an estimated of 200 filled files.
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| Measure | Description | Time Frame |
|---|---|---|
| Describe epidemiological characteristics of patients diagnosed with NSCLC in Brazil real-world. | Clinical and demographic data will be extracted from medical records (gender, age at diagnosis, self-reported ethnicity, state, institutional profile (public or private), smoking status, lung cancer family history), clinical characteristics such as comorbidities, histology, extent of disease, metastasis location, tumor stage at diagnosis according AJCC eighth edition, ECOG status, frequency of biomarker and molecular testing (PDL-1 status, EGFR, ALK, ROS1, BRAF, NTRK, MET, HER2, KRAS, STK11, KEAP1). Descriptive statistics will be used to summarize the epidemiological characteristics. | Through study completation, an average of 2 years |
| Describe first-line NSCLC treatment patterns in Brazil real-world. | The therapeutic choice: platinum-based therapy, ICI in monotherapy or combined, targeted therapy regimen for patients with driver mutations, TKI inhibitors, bi-specifics, ALK inhibitors, etc, will be extracted from medical records. Descriptive statistics will be used to summarize the treatment patterns. | Through study completation, an average of 2 years |
| Evaluate the concordance between the therapeutic choices and the BSCO guidelines. | The concordance of real-life scenarios with the therapeutic guidelines of the Brazilian Society of Clinical Oncology (BSCO) will be assessed using Cohen's kappa coefficient. | Through study completation, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Describe of the epidemiological characteristics and first-line therapeutic patterns according all locally approved treatment approaches in NSCLC patients. | The therapeutic choice on each scenario (according to EGFR, ALK, ROS1, BRAF, NTRK, MET, HER2, KRAS, STK11, KEAP1 mutations and PDL-1 status) will be collected from medical records and described on this project using descriptive statistics. | Through study completation,an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with advanced non-small cell lung carcinoma, treated in one of the seven centers selected, between January 2025 and January 2026.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
| Name | Affiliation | Role |
|---|---|---|
| Clarissa Baldotto | Instituto D'Or de Pesquisa e Ensino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Active, not recruiting | Recife | Brazil | |||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Evaluate the influence of the mutational profile and PD-L1 expression on the choice of treatment. | Mutational profile and PD-L1 (presence of KRAS, KEAP1, STK11, SMARC4 co-mutations) will be collected from medical records. The influence of the mutational profile and PD-L1 expression on treatment choice will be assessed using descriptive statistics. | Through study completation, an average of 2 years |
| Evaluate the influence of clinical characteristics and mutational profile on the choice of first line treatment on EGFR mutated non-small cell lung cancer patients. | The influence of clinical characteristics and mutational profile on the choice of first-line treatment for EGFR-mutated NSCLC patients (collected from medical records) will be assessed using descriptive statistics. | Through study completation, an average of 2 years |
| Evaluate differences between patterns of choice in first-line treatment between generalist medical oncologists through an online survey. | Through a survey targeting thoracic and generalist medical oncologists with an estimated of 300 oncologists contacted. The differences in patterns of choice for first-line treatment among generalist medical oncologists will be summarized using descriptive statistics and compared using the Chi-squared test (or Fisher's exact test). | Through study completation, an average of 2 years |
| Recruiting |
| Rio de Janeiro |
| Brazil |
| Research Site | Not yet recruiting | Rio de Janeiro | Brazil |
| Research Site | Recruiting | Salvador | Brazil |
| Research Site | Not yet recruiting | Salvador | Brazil |
| Research Site | Active, not recruiting | São Paulo | Brazil |
| Research Site | Not yet recruiting | São Paulo | Brazil |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |