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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. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

250

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sociodemographic Characteristics: Age
Zeitfenster: Baseline
Age in years of the participants will be reported.
Baseline
Sociodemographic Characteristics: Sex
Zeitfenster: Baseline
Sex (male, female) of the participants will be reported.
Baseline
Sociodemographic Characteristics: Weight
Zeitfenster: Baseline
Weight (in kilograms [kg]) of the participants will be reported.
Baseline
Sociodemographic Characteristics: Smoking Status
Zeitfenster: Baseline
Participants smoking status that is current or former smoker will be reported.
Baseline
Sociodemographic Characteristics: Eastern Cooperative Oncology Group (ECOG) Performance Status
Zeitfenster: Baseline
ECOG performance status of the participants will be reported.
Baseline
Sociodemographic Characteristics: Disease Histopathology
Zeitfenster: Baseline
Number of participants based on disease histopathology will be reported.
Baseline
Sociodemographic Characteristics: Type of Mutation
Zeitfenster: Baseline
Number of participants based on type of mutation will be reported.
Baseline
Sociodemographic Characteristics: Disease Stage
Zeitfenster: Baseline
Number of participants based on the stage of disease will be reported.
Baseline
Sociodemographic Characteristics: Cancer Metastasis
Zeitfenster: Baseline
Number of participants based on cancer metastasis will be reported.
Baseline
EGFR Mutation Prevalence
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Frequency of EGFR Mutations
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Janssen-Cilag Farmaceutica Ltda.

Ermittler

  • Studienleiter: Janssen-Cilag Farmaceutica, Lda. Clinical Trial, Janssen-Cilag Farmaceutica, Lda.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. Juli 2026

Primärer Abschluss (Geschätzt)

30. August 2026

Studienabschluss (Geschätzt)

30. September 2026

Studienanmeldedaten

Zuerst eingereicht

26. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Juni 2026

Zuerst gepostet (Tatsächlich)

2. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 61186372NSC4016 (Andere Kennung: Janssen Research & Development, LLC)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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