Lung Cancer Non-small Cell Stage IVNCT05127382
Osimertinib as 1st Line Therapy for Patients With Advanced EGFR Positive Non-Small Cell Lung Cancer
An observational study of Lung Cancer Non-small Cell Stage IV, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Non-small Cell Stage IV
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2020to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the detailed 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.
- Conditions
- Lung Cancer Non-small Cell Stage IV
- Keywords
- non-small cell lung cancer, egfr mutation, osimertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| untreated patients with advanced EGFR positive non-small cell lung cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
the time from treatment initiation to either the first documented disease progression or death from any cause
Measured: through the completion of the study, up to 2 years
Secondary outcomes (6)
overall survival (OS)
the time from treatment initiation to patient death or last contact
Measured: through the completion of the study, up to 2 years
overall response rate (ORR)
the response rate for all enrolled population and for the response evaluable population
Measured: through the completion of the study, up to 2 years
quality of life data
quality of life data through EQ-5D-5L questionnaire
Measured: through the completion of the study, up to 2 years
Safety profile and toxicity
Rates of adverse events because of treatment with osimertinib
Measured: through the completion of the study, up to 2 years
health economics
description of health costs to determine cost-effectiveness of osimertinib
Measured: through the completion of the study, up to 2 years
second progression-free survival (PFS2)
time from treatment initiation to objective tumour progression on next-line treatment or death from any cause
Measured: through the completion of the study, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Feb 2020
- Primary completion15 May 2026
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Non-small Cell Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127382
- Sponsor's protocol ID
- HE219
- Status last verified
- Oct 2026
- First submitted
- 9 Nov 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05127382
- Acronym / sponsor ID
- HE219
- Conditions
- Lung Cancer Non-small Cell Stage IV
- Keywords
- non-small cell lung cancer, egfr mutation, osimertinib
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| untreated patients with advanced EGFR positive non-small cell lung cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
progression-free survival (PFS)
Time frame: through the completion of the study, up to 2 years
the time from treatment initiation to either the first documented disease progression or death from any cause
6 secondary outcomes
overall survival (OS)
Time frame: through the completion of the study, up to 2 years
overall response rate (ORR)
Time frame: through the completion of the study, up to 2 years
quality of life data
Time frame: through the completion of the study, up to 2 years
Safety profile and toxicity
Time frame: through the completion of the study, up to 2 years
health economics
Time frame: through the completion of the study, up to 2 years
second progression-free survival (PFS2)
Time frame: through the completion of the study, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer Non-small Cell Stage IV, run by Hellenic Cooperative Oncology Group at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: through the completion of the study, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.