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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 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

250

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency of EGFR Mutations
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen-Cilag Farmaceutica Ltda.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. juli 2026

Primær færdiggørelse (Anslået)

30. august 2026

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 61186372NSC4016 (Anden identifikator: Janssen Research & Development, LLC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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