An observational study in Carcinoma, Non-Small-Cell Lung, sponsored by Janssen-Cilag Farmaceutica Ltda.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Janssen-Cilag Farmaceutica Ltda. · Observational
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's planned enrollment of 250 is above the median of 161 across 948 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Janssen-Cilag Farmaceutica Ltda. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion criteria:
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.
Sociodemographic Characteristics: Age
Age in years of the participants will be reported.
Time frame: Baseline
Sociodemographic Characteristics: Sex
Sex (male, female) of the participants will be reported.
Time frame: Baseline
Sociodemographic Characteristics: Weight
Weight (in kilograms \[kg\]) of the participants will be reported.
Time frame: Baseline
Sociodemographic Characteristics: Smoking Status
Participants smoking status that is current or former smoker will be reported.
Time frame: Baseline
Sociodemographic Characteristics: Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG performance status of the participants will be reported.
Time frame: Baseline
Sociodemographic Characteristics: Disease Histopathology
Number of participants based on disease histopathology will be reported.
Time frame: Baseline
Sociodemographic Characteristics: Type of Mutation
Number of participants based on type of mutation will be reported.
Time frame: Baseline
Sociodemographic Characteristics: Disease Stage
Number of participants based on the stage of disease will be reported.
Time frame: Baseline
Sociodemographic Characteristics: Cancer Metastasis
Number of participants based on cancer metastasis will be reported.
Time frame: Baseline
EGFR Mutation Prevalence
Number of participants with EGFR mutations will be reported.
Time frame: Up to approximately 7 years 9 months
Percentage of Participants by Type of Mutation of EGFR
Percentage of participants by type of mutation of EGFR will be reported.
Time frame: Up to approximately 7 years 9 months
Frequency of EGFR Mutations
Frequency of EGFR mutations will be reported.
Time frame: Up to approximately 7 years 9 months
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.
Time frame: Up to approximately 7 years 9 months
Real-World Overall Survival (RW-OS)
RW-OS is defined as time elapsed between index date and date of death from any cause.
Time frame: Up to approximately 7 years 9 months
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.
Time frame: Up to approximately 7 years 9 months
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.
Time frame: Up to approximately 7 years 9 months
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.
Time frame: Up to approximately 7 years 9 months
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.
Time frame: Up to approximately 7 years 9 months
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.
Time frame: Up to approximately 7 years 9 months
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.
Time frame: Up to approximately 7 years 9 months
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.
Time frame: Up to approximately 7 years 9 months
Number Participants with Emergency Room Visits Related to NSCLC
Number of participants with emergency room visits related to NSCLC will be reported.
Time frame: Up to approximately 7 years 9 months
Percentage of Participants Hospitalized
Percentage of participants with at least one hospitalization will be reported.
Time frame: Up to approximately 7 years 9 months
Number of Hospitalizations
Total number of hospitalizations for the participants will be reported.
Time frame: Up to approximately 7 years 9 months
Median Length of Stay
Median length of stay in days per hospitalization will be reported.
Time frame: Up to approximately 7 years 9 months
Net Costing
The net cost of different treatment practices per participants will be reported.
Time frame: Up to approximately 7 years 9 months
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Janssen-Cilag Farmaceutica Ltda.