Osimertinib as 1st Line Therapy for Patients With Advanced EGFR Positive Non-Small Cell Lung Cancer

NCT05127382 | Unknown

• 1 other identifier: HE219
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will evaluate the use of osimertinib as 1st line therapy for patients with advanced EGFR positive non-small cell lung cancer who are treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology.

Conditions

Lung Cancer Non-small Cell Stage IV

Keywords

non-small cell lung cancer; egfr mutation; osimertinib

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  the time from treatment initiation to either the first documented disease progression or death from any cause

  through the completion of the study, up to 2 years

Secondary Outcomes (6)

• overall survival (OS)

  through the completion of the study, up to 2 years

• overall response rate (ORR)

  through the completion of the study, up to 2 years

• quality of life data

  through the completion of the study, up to 2 years

• Safety profile and toxicity

  through the completion of the study, up to 2 years

• health economics

  through the completion of the study, up to 2 years

Study Arms (1)

untreated patients with advanced EGFR positive non-small cell lung cancer

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

patients with advanced EGFR positive non-small cell lung cancer that receive osimertinib as 1st line therapy and are treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology

You may qualify if:

• men or women of 18 years or older that live in Greece
• histologically or cytologically confirmed, advanced EGFR positive non-small cell lung cancer
• untreated patients for advanced NSCLC
• patients who are expected to receive osimertinib regardless of their enrollment in the study
• signed written informed consent

You may not qualify if:

• patients with cancer other than NSCLC that require treatment
• pretreated patients for NSCLC
• patients that receive or are expected to receive or have received an investigational drug/product/intervention

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (1)

Hellenic Cooperative Oncology Group

Athens, 11526, Greece

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected from patients with advanced egfr positive non-small cell lung cancer

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

Central Study Contacts

Maria Drizou, MD

CONTACT

+30 2104807252; drizoumaria@gmail.com

Maria Moschoni

CONTACT

+30 2106912520; m_moschoni@hecog.ondsl.gr

Study Design

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

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 19, 2021
• Study Start: February 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: January 31, 2025
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

GR (1)