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

NCT07680907 | Not Yet Recruiting

• 1 other identifier: 61186372NSC4016
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (11)

• Sociodemographic Characteristics: Age

  Age in years of the participants will be reported.

  Baseline

• Sociodemographic Characteristics: Sex

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

  Baseline

• Sociodemographic Characteristics: Weight

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

  Baseline

• Sociodemographic Characteristics: Smoking Status

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

  Baseline

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

  ECOG performance status of the participants will be reported.

  Baseline

• Sociodemographic Characteristics: Disease Histopathology

  Number of participants based on disease histopathology will be reported.

  Baseline

• Sociodemographic Characteristics: Type of Mutation

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

  Baseline

• Sociodemographic Characteristics: Disease Stage

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

  Baseline

• Sociodemographic Characteristics: Cancer Metastasis

  Number of participants based on cancer metastasis will be reported.

  Baseline

• EGFR Mutation Prevalence

  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

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

  Up to approximately 7 years 9 months

Secondary Outcomes (15)

• Frequency of EGFR Mutations

  Up to approximately 7 years 9 months

• Number of Participants by Treatment Options

  Up to approximately 7 years 9 months

• Real-World Overall Survival (RW-OS)

  Up to approximately 7 years 9 months

• Real-World Progression-Free Survival (RW-PFS)

  Up to approximately 7 years 9 months

• RW-PFS from First Line of Treatment (RW-PFS 2)

  Up to approximately 7 years 9 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen-Cilag Farmaceutica Ltda.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Janssen-Cilag Farmaceutica, Lda. Clinical Trial

  Janssen-Cilag Farmaceutica, Lda.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share