DeniLA: Comprehensive Demographics and Clinical Profile of NSCLC Patients: Analyzing Guideline-Concordant Care in First-line Treatment Patterns

NCT ID: NCT07109154

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-25

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Neoplasms

Keywords

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Advanced Non Small Cell Lung Câncer; Driver mutations; PD-L1 expression; Real World Evidence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Advanced (unresectable or metastatic) non-small cell lung carcinoma
* First-line oncological treatment in one of the participating centers between 2025 and 2026 (between January 2025 and January 2026)
* \> 18 years old
* Data available in electronic medical records.

Exclusion Criteria

* Localized disease amenable to local treatment
* Non-epithelial histology
* Small cell carcinoma
* Neuroendocrine tumor
* Patients with unresectable NSCLC who underwent treatment with the PACIFIC protocol and are being followed up.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clarissa Baldotto

Role: PRINCIPAL_INVESTIGATOR

Instituto D'Or de Pesquisa e Ensino

Locations

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Research Site

Recife, , Brazil

Site Status ACTIVE_NOT_RECRUITING

Research Site

Rio de Janeiro, , Brazil

Site Status RECRUITING

Research Site

Rio de Janeiro, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Salvador, , Brazil

Site Status RECRUITING

Research Site

Salvador, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

São Paulo, , Brazil

Site Status ACTIVE_NOT_RECRUITING

Research Site

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Countries

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Brazil

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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D133FR00224

Identifier Type: -

Identifier Source: org_study_id