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

Lung Cancer Non-small Cell Stage IV Clinical Trial

Official title:

Osimertinib as First Line Therapy for Patients With Advanced EGFR Positive Non-Small Cell Lung Cancer: the Experience of the Hellenic Cooperative Oncology Group (HeCOG)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05127382
• Other study ID #: HE219
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2023
• Source: Hellenic Cooperative Oncology Group
• Contact: Maria Drizou, MD
• Phone: +30 2104807252
• Email: drizoumaria[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This will be an observational, multicentric, retrospective/ prospective analysis of patients with advanced EGFR positive non-small cell lung cancer that receive osimertinib as 1st line therapy. The patient data will be collected at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology during scheduled patient clinical visits, from February 2020 for a total period of three years. The biological material obtained from the patients of this analysis will be possibly used in a future translational study as an exploratory analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer Non-small Cell Stage IV
• Lung Neoplasms

Locations

Country	Name	City	State
Greece	Hellenic Cooperative Oncology Group	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Cooperative Oncology Group

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	overall survival (OS)	the time from treatment initiation to patient death or last contact	through the completion of the study, up to 2 years
Secondary	overall response rate (ORR)	the response rate for all enrolled population and for the response evaluable population	through the completion of the study, up to 2 years
Secondary	quality of life data	quality of life data through EQ-5D-5L questionnaire	through the completion of the study, up to 2 years
Secondary	Safety profile and toxicity	Rates of adverse events because of treatment with osimertinib	through the completion of the study, up to 2 years
Secondary	health economics	description of health costs to determine cost-effectiveness of osimertinib	through the completion of the study, up to 2 years
Secondary	second progression-free survival (PFS2)	time from treatment initiation to objective tumour progression on next-line treatment or death from any cause	through the completion of the study, up to 2 years