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

NCT07109154 | Recruiting

• 1 other identifier: D133FR00224
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Lung Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• Describe of the epidemiological characteristics and first-line therapeutic patterns according all locally approved treatment approaches in NSCLC patients.

  Through study completation,an average of 2 years

• Evaluate the influence of the mutational profile and PD-L1 expression on the choice of treatment.

  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.

  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 study completation, an average of 2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with advanced non-small cell lung carcinoma, treated in one of the seven centers selected, between January 2025 and January 2026.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Research Site

Recife, Brazil

ACTIVE NOT RECRUITING

Research Site

Rio de Janeiro, Brazil

RECRUITING

Research Site

Rio de Janeiro, Brazil

NOT YET RECRUITING

Research Site

Salvador, Brazil

RECRUITING

Research Site

Salvador, Brazil

NOT YET RECRUITING

Research Site

São Paulo, Brazil

ACTIVE NOT RECRUITING

Research Site

São Paulo, Brazil

NOT YET RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clarissa Baldotto

  Instituto D'Or de Pesquisa e Ensino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 7, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.
• Access Criteria: 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.

Locations

BR (7)