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A Real World Study of Participants With Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor Mutation (EGFRm) (LuCaRTE)

26 giugno 2026 aggiornato da: Janssen-Cilag Farmaceutica Ltda.

Characterization of the Population, Treatment Patterns and Outcomes of Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor Mutation (EGFRm) - Multicenter Retrospective Cohort Study

This study aims to better understand people who have advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR mutation. NSCLC is an advanced stage cancer of the lung, occurring due to mutations (changes) in the EGFR gene. The study will assess the participant demographic background (that is age, gender etc.), the treatments they receive, how well those treatments work, and their health outcomes.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

250

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adult participants (aged greater than or equal to [>=] 18 years) with a histologically or cytologically confirmed diagnosis of NSCLC, unresectable stage IIIB/C or IV at diagnosis, and a documented EGFR mutation.

Descrizione

Inclusion criteria:

  • Histologically or cytologically confirmed diagnosis of advanced or metastatic unresectable non-small cell lung cancerNSCLC (TNM stages IIIB-IV), and a documented EGFR mutation, between 01 July 2018 and 31 March 2022
  • Diagnosed and treated at one of the participating study centers within the defined study period

Exclusion criteria:

  • Participants who received any systemic cancer treatment outside the participating treatment centers
  • Participants diagnosed with any other malignancy within the 5 years prior to or during the study period, with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma
  • Participants enrolled in clinical trials during the study period.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Unresectable Epidermal Growth Factor Receptor Mutated (EGFRm) NSCLC
Participants with a histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC), unresectable stage IIIB/C or IV at diagnosis, and a documented EGFR mutation will be included in this cohort. The existing secondary data from electronic health records (EHR) of these participants from approximately five selected Portuguese healthcare sites will be processed. Each participant will be followed up from index date (date on which participant is included in study) up to 31 March 2026 or at censoring, No intervention will be provided as a part of this study.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sociodemographic Characteristics: Age
Lasso di tempo: Baseline
Age in years of the participants will be reported.
Baseline
Sociodemographic Characteristics: Sex
Lasso di tempo: Baseline
Sex (male, female) of the participants will be reported.
Baseline
Sociodemographic Characteristics: Weight
Lasso di tempo: Baseline
Weight (in kilograms [kg]) of the participants will be reported.
Baseline
Sociodemographic Characteristics: Smoking Status
Lasso di tempo: Baseline
Participants smoking status that is current or former smoker will be reported.
Baseline
Sociodemographic Characteristics: Eastern Cooperative Oncology Group (ECOG) Performance Status
Lasso di tempo: Baseline
ECOG performance status of the participants will be reported.
Baseline
Sociodemographic Characteristics: Disease Histopathology
Lasso di tempo: Baseline
Number of participants based on disease histopathology will be reported.
Baseline
Sociodemographic Characteristics: Type of Mutation
Lasso di tempo: Baseline
Number of participants based on type of mutation will be reported.
Baseline
Sociodemographic Characteristics: Disease Stage
Lasso di tempo: Baseline
Number of participants based on the stage of disease will be reported.
Baseline
Sociodemographic Characteristics: Cancer Metastasis
Lasso di tempo: Baseline
Number of participants based on cancer metastasis will be reported.
Baseline
EGFR Mutation Prevalence
Lasso di tempo: Up to approximately 7 years 9 months
Number of participants with EGFR mutations will be reported.
Up to approximately 7 years 9 months
Percentage of Participants by Type of Mutation of EGFR
Lasso di tempo: Up to approximately 7 years 9 months
Percentage of participants by type of mutation of EGFR will be reported.
Up to approximately 7 years 9 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Frequency of EGFR Mutations
Lasso di tempo: Up to approximately 7 years 9 months
Frequency of EGFR mutations will be reported.
Up to approximately 7 years 9 months
Number of Participants by Treatment Options
Lasso di tempo: Up to approximately 7 years 9 months
Participants with different treatment options such as targeted therapy, chemotherapy, immunotherapy, surgery, radiotherapy stratified by type of mutation will be reported.
Up to approximately 7 years 9 months
Real-World Overall Survival (RW-OS)
Lasso di tempo: Up to approximately 7 years 9 months
RW-OS is defined as time elapsed between index date and date of death from any cause.
Up to approximately 7 years 9 months
Real-World Progression-Free Survival (RW-PFS)
Lasso di tempo: Up to approximately 7 years 9 months
RW-PFS is defined as the time elapsed between the start of a new line of treatment to the date of documented disease progression or death from any cause, whichever occurs first.
Up to approximately 7 years 9 months
RW-PFS from First Line of Treatment (RW-PFS 2)
Lasso di tempo: Up to approximately 7 years 9 months
RW-PFS 2 is defined as the time elapsed between the start of a first line of treatment to the date of documented second disease progression or death from any cause, whichever occurs first.
Up to approximately 7 years 9 months
Real-World Time on Treatment (RW-TOT)
Lasso di tempo: Up to approximately 7 years 9 months
RW-TOT is defined as the time elapsed between the start date of a line of treatment to the date of treatment discontinuation for any reason.
Up to approximately 7 years 9 months
Real-World Time to Next Treatment (RW-TTNT)
Lasso di tempo: Up to approximately 7 years 9 months
RW-TTNT is defined as the time elapsed between the start of a given line of treatment to the initiation of the subsequent line of systemic therapy.
Up to approximately 7 years 9 months
Real-World Overall Response Rate (RW-ORR)
Lasso di tempo: Up to approximately 7 years 9 months
RW-ORR is defined as the percentage of participants whose cancer show partial response or complete response of all target lesions following a specific line of treatment.
Up to approximately 7 years 9 months
Number of Appointments
Lasso di tempo: Up to approximately 7 years 9 months
Number of appointments related to NSCLC by line of treatment such as oncology, pulmonology, primary care, radio-oncology, thoracic surgery, nursing, psychology, nutrition, physiotherapy will be reported.
Up to approximately 7 years 9 months
Number of Participants Receiving Complementary Diagnostic and Therapeutic Procedures
Lasso di tempo: Up to approximately 7 years 9 months
Number of participants receiving complementary diagnostic and therapeutic procedures and type of complementary diagnostic and therapeutic procedures received (for example, imaging, laboratory tests, biopsies, radiotherapy sessions, surgery, medication) will be reported.
Up to approximately 7 years 9 months
Number Participants with Emergency Room Visits Related to NSCLC
Lasso di tempo: Up to approximately 7 years 9 months
Number of participants with emergency room visits related to NSCLC will be reported.
Up to approximately 7 years 9 months
Percentage of Participants Hospitalized
Lasso di tempo: Up to approximately 7 years 9 months
Percentage of participants with at least one hospitalization will be reported.
Up to approximately 7 years 9 months
Number of Hospitalizations
Lasso di tempo: Up to approximately 7 years 9 months
Total number of hospitalizations for the participants will be reported.
Up to approximately 7 years 9 months
Median Length of Stay
Lasso di tempo: Up to approximately 7 years 9 months
Median length of stay in days per hospitalization will be reported.
Up to approximately 7 years 9 months
Net Costing
Lasso di tempo: Up to approximately 7 years 9 months
The net cost of different treatment practices per participants will be reported.
Up to approximately 7 years 9 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen-Cilag Farmaceutica Ltda.

Investigatori

  • Direttore dello studio: Janssen-Cilag Farmaceutica, Lda. Clinical Trial, Janssen-Cilag Farmaceutica, Lda.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 luglio 2026

Completamento primario (Stimato)

30 agosto 2026

Completamento dello studio (Stimato)

30 settembre 2026

Date di iscrizione allo studio

Primo inviato

26 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

26 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 61186372NSC4016 (Altro identificatore: Janssen Research & Development, LLC)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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