Lung NeoplasmsDeniLANCT07109154
DeniLA: Comprehensive Demographics and Clinical Profile of NSCLC Patients: Analyzing Guideline-Concordant Care in First-line Treatment Patterns
An observational study of Lung Neoplasms, run by AstraZeneca at 7 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Neoplasms
- How many people
- 200 participants
- Where
- 7 sitesBrazil
- Study dates
- 25 Nov 2025to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
7 sites in 1 country
Brazil7 sites, 5 recruiting
- Active, not recruiting
Research Site
Recife
- Recruiting
Research Site
Rio de Janeiro
- Not yet recruiting
Research Site
Rio de Janeiro
- Recruiting
Research Site
Salvador
- Not yet recruiting
Research Site
Salvador
- Active, not recruiting
Research Site
São Paulo
- Not yet recruiting
Research Site
São Paulo
About this study
Official title: DeniLA: Comprehensive Demographics and Clinical Profile of NSCLC Patients: Analyzing Guideline-Concordant Care in First-line Treatment Patterns Observational Study (Prospective and Survey); Evaluation Patterns of Choice in First Line Treatment of Metastatic NSCLC
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.
Read more
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
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: Through study completation,an average of 2 years
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.
Measured: 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.
Measured: 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).
Measured: Through study completation, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start25 Nov 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clarissa Baldotto, Principal investigator, Instituto D'Or de Pesquisa e Ensino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109154
- Sponsor's protocol ID
- D133FR00224
- Acronym
- DeniLA
- Status last verified
- May 2026
- First submitted
- 16 Jul 2025
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DeniLA: Comprehensive Demographics and Clinical Profile of NSCLC Patients: Analyzing Guideline-Concordant Care in First-line Treatment Patterns Observational Study (Prospective and Survey); Evaluation Patterns of Choice in First Line Treatment of Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT07109154
- Acronym / sponsor ID
- DeniLA / D133FR00224
- Conditions
- Lung Neoplasms
- Keywords
- Advanced Non Small Cell Lung Câncer;, Driver mutations;, PD-L1 expression;, Real World Evidence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe epidemiological characteristics of patients diagnosed with NSCLC in Brazil real-world.
Time frame: Through study completation, an average of 2 years
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.
Describe first-line NSCLC treatment patterns in Brazil real-world.
Time frame: Through study completation, an average of 2 years
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.
Evaluate the concordance between the therapeutic choices and the BSCO guidelines.
Time frame: Through study completation, an average of 2 years
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.
4 secondary outcomes
Describe of the epidemiological characteristics and first-line therapeutic patterns according all locally approved treatment approaches in NSCLC patients.
Time frame: Through study completation,an average of 2 years
Evaluate the influence of the mutational profile and PD-L1 expression on the choice of treatment.
Time frame: 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.
Time frame: 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.
Time frame: Through study completation, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Lung Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
Clarissa Baldotto principal investigator
Instituto D'Or de Pesquisa e Ensino
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, run by AstraZeneca at 7 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe epidemiological characteristics of patients diagnosed with NSCLC in Brazil real-world. (time frame: Through study completation, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.