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Carcinoma, Non-Small-Cell LungLuCaRTENCT07680907

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

An observational study of Carcinoma, Non-Small-Cell Lung, run by Janssen-Cilag Farmaceutica Ltda..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
Type of treatment
Injection or infusion
How many people
250 participants
Where
No sites listed yet
Study dates
31 Oct 2026to 31 Dec 2026
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

About this study

Official 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

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.

Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07680907
Study groupRoleWhat they receive
Unresectable Epidermal Growth Factor Receptor Mutated (EGFRm) NSCLCParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sociodemographic Characteristics: Age

    Age in years of the participants will be reported.

    Measured: Baseline

  2. Sociodemographic Characteristics: Sex

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

    Measured: Baseline

  3. Sociodemographic Characteristics: Weight

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

    Measured: Baseline

  4. Sociodemographic Characteristics: Smoking Status

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

    Measured: Baseline

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

    ECOG performance status of the participants will be reported.

    Measured: Baseline

  6. Sociodemographic Characteristics: Disease Histopathology

    Number of participants based on disease histopathology will be reported.

    Measured: Baseline

  7. Sociodemographic Characteristics: Type of Mutation

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

    Measured: Baseline

  8. Sociodemographic Characteristics: Disease Stage

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

    Measured: Baseline

  9. Sociodemographic Characteristics: Cancer Metastasis

    Number of participants based on cancer metastasis will be reported.

    Measured: Baseline

  10. EGFR Mutation Prevalence

    Number of participants with EGFR mutations will be reported.

    Measured: Up to approximately 7 years 9 months

  11. Percentage of Participants by Type of Mutation of EGFR

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

    Measured: Up to approximately 7 years 9 months

Secondary outcomes (15)

  1. Frequency of EGFR Mutations

    Frequency of EGFR mutations will be reported.

    Measured: Up to approximately 7 years 9 months

  2. Number of Participants by Treatment Options

    Participants with different treatment options such as targeted therapy, chemotherapy, immunotherapy, surgery, radiotherapy stratified by type of mutation will be reported.

    Measured: Up to approximately 7 years 9 months

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

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

    Measured: Up to approximately 7 years 9 months

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

    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.

    Measured: Up to approximately 7 years 9 months

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

    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.

    Measured: Up to approximately 7 years 9 months

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

    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.

    Measured: Up to approximately 7 years 9 months

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

    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.

    Measured: Up to approximately 7 years 9 months

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

    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.

    Measured: Up to approximately 7 years 9 months

  9. Number of Appointments

    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.

    Measured: Up to approximately 7 years 9 months

  10. Number of Participants Receiving Complementary Diagnostic and Therapeutic Procedures

    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.

    Measured: Up to approximately 7 years 9 months

  11. Number Participants with Emergency Room Visits Related to NSCLC

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

    Measured: Up to approximately 7 years 9 months

  12. Percentage of Participants Hospitalized

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

    Measured: Up to approximately 7 years 9 months

  13. Number of Hospitalizations

    Total number of hospitalizations for the participants will be reported.

    Measured: Up to approximately 7 years 9 months

  14. Median Length of Stay

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

    Measured: Up to approximately 7 years 9 months

  15. Net Costing

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

    Measured: Up to approximately 7 years 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study start31 Oct 2026 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07680907
Sponsor's protocol ID
61186372NSC4016
Other IDs
61186372NSC4016
Acronym
LuCaRTE
Status last verified
Aug 2026
First submitted
26 Jun 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Carcinoma, Non-Small-Cell Lung, run by Janssen-Cilag Farmaceutica Ltda..

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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sociodemographic Characteristics: Age (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07680907.

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 28 Aug 2026.

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