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Not yet recruiting NCT07680907

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

— Observational Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Carcinoma, Non-Small-Cell Lung. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Primary outcome measures

  • Sociodemographic Characteristics: Age [Time frame: Baseline]
  • Sociodemographic Characteristics: Sex [Time frame: Baseline]
  • Sociodemographic Characteristics: Weight [Time frame: Baseline]
  • Sociodemographic Characteristics: Smoking Status [Time frame: Baseline]
  • Sociodemographic Characteristics: Eastern Cooperative Oncology Group (ECOG) Performance Status [Time frame: Baseline]
  • Sociodemographic Characteristics: Disease Histopathology [Time frame: Baseline]
  • Sociodemographic Characteristics: Type of Mutation [Time frame: Baseline]
  • Sociodemographic Characteristics: Disease Stage [Time frame: Baseline]
  • Sociodemographic Characteristics: Cancer Metastasis [Time frame: Baseline]
  • EGFR Mutation Prevalence [Time frame: Up to approximately 7 years 9 months]
Secondary outcome measures (12)
  • Frequency of EGFR Mutations [Time frame: Up to approximately 7 years 9 months]
  • Number of Participants by Treatment Options [Time frame: Up to approximately 7 years 9 months]
  • Real-World Overall Survival (RW-OS) [Time frame: Up to approximately 7 years 9 months]
  • Real-World Progression-Free Survival (RW-PFS) [Time frame: Up to approximately 7 years 9 months]
  • RW-PFS from First Line of Treatment (RW-PFS 2) [Time frame: Up to approximately 7 years 9 months]
  • Real-World Time on Treatment (RW-TOT) [Time frame: Up to approximately 7 years 9 months]
  • Real-World Time to Next Treatment (RW-TTNT) [Time frame: Up to approximately 7 years 9 months]
  • Real-World Overall Response Rate (RW-ORR) [Time frame: Up to approximately 7 years 9 months]
  • Number of Appointments [Time frame: Up to approximately 7 years 9 months]
  • Number of Participants Receiving Complementary Diagnostic and Therapeutic Procedures [Time frame: Up to approximately 7 years 9 months]
  • Number Participants with Emergency Room Visits Related to NSCLC [Time frame: Up to approximately 7 years 9 months]
  • Percentage of Participants Hospitalized [Time frame: Up to approximately 7 years 9 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07680907 · 61186372NSC4016 · 61186372NSC4016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗