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NCT Number: NCT07680907

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sociodemographic Characteristics: Age

    Time frame: Baseline

    Age in years of the participants will be reported.

  2. Sociodemographic Characteristics: Sex

    Time frame: Baseline

    Sex (male, female) of the participants will be reported.

  3. Sociodemographic Characteristics: Weight

    Time frame: Baseline

    Weight (in kilograms [kg]) of the participants will be reported.

  4. Sociodemographic Characteristics: Smoking Status

    Time frame: Baseline

    Participants smoking status that is current or former smoker will be reported.

  5. Sociodemographic Characteristics: Eastern Cooperative Oncology Group (ECOG) Performance Status

    Time frame: Baseline

    ECOG performance status of the participants will be reported.

  6. Sociodemographic Characteristics: Disease Histopathology

    Time frame: Baseline

    Number of participants based on disease histopathology will be reported.

  7. Sociodemographic Characteristics: Type of Mutation

    Time frame: Baseline

    Number of participants based on type of mutation will be reported.

  8. Sociodemographic Characteristics: Disease Stage

    Time frame: Baseline

    Number of participants based on the stage of disease will be reported.

  9. Sociodemographic Characteristics: Cancer Metastasis

    Time frame: Baseline

    Number of participants based on cancer metastasis will be reported.

  10. EGFR Mutation Prevalence

    Time frame: Up to approximately 7 years 9 months

    Number of participants with EGFR mutations will be reported.

  11. Percentage of Participants by Type of Mutation of EGFR

    Time frame: Up to approximately 7 years 9 months

    Percentage of participants by type of mutation of EGFR will be reported.

Secondary outcomes

  1. Frequency of EGFR Mutations

    Time frame: Up to approximately 7 years 9 months

    Frequency of EGFR mutations will be reported.

  2. Number of Participants by Treatment Options

    Time frame: 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.

  3. Real-World Overall Survival (RW-OS)

    Time frame: Up to approximately 7 years 9 months

    RW-OS is defined as time elapsed between index date and date of death from any cause.

  4. Real-World Progression-Free Survival (RW-PFS)

    Time frame: 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.

  5. RW-PFS from First Line of Treatment (RW-PFS 2)

    Time frame: 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.

  6. Real-World Time on Treatment (RW-TOT)

    Time frame: 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.

  7. Real-World Time to Next Treatment (RW-TTNT)

    Time frame: 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.

  8. Real-World Overall Response Rate (RW-ORR)

    Time frame: 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.

  9. Number of Appointments

    Time frame: 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.

  10. Number of Participants Receiving Complementary Diagnostic and Therapeutic Procedures

    Time frame: 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.

  11. Number Participants with Emergency Room Visits Related to NSCLC

    Time frame: Up to approximately 7 years 9 months

    Number of participants with emergency room visits related to NSCLC will be reported.

  12. Percentage of Participants Hospitalized

    Time frame: Up to approximately 7 years 9 months

    Percentage of participants with at least one hospitalization will be reported.

  13. Number of Hospitalizations

    Time frame: Up to approximately 7 years 9 months

    Total number of hospitalizations for the participants will be reported.

  14. Median Length of Stay

    Time frame: Up to approximately 7 years 9 months

    Median length of stay in days per hospitalization will be reported.

  15. Net Costing

    Time frame: Up to approximately 7 years 9 months

    The net cost of different treatment practices per participants will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Farmaceutica Ltda.

Industry

Registry information

Official study title

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

Acronym: LuCaRTE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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