LUCC Lung Cohort
PREDICT-EGFR Project
Multicenter Retrospective Study — Information for Patients and the Public — LUCC Lung Cancer Framework Project
Lifen - Data intelligence for healthcare professionals - Medical document management platform
Sponsors
Saint-Joseph Hospital Foundation (Paris Saint-Joseph and Marie Lannelongue Hospitals)
Status
Project in progress
Data retention period
To be completed

Acknowledgments

We would like to sincerely thank everyone whose health data is contributing to this research. Without your participation, this study would not be possible. Every contribution helps researchers better understand lung cancer and improve care for patients today and in the future.

In brief

Study Name: PREDICT-EGFR

Study type: Retrospective study (i.e., based on medical information already collected in the past, without any changes to your care).

Main objective: To identify criteria that can predict the duration of response to osimertinib treatment in patients with lung cancer harboring an EGFR gene mutation, in order to help physicians better select the most appropriate treatment for each patient.

Number of patients involved: Approximately 300 people.

Country: France (11 hospitals and cancer treatment centers).

Study period: Patients treated through January 1, 2024, are included. The analysis is expected to be completed in the first quarter of 2026.

Impact on your care: None. This study has no direct impact on your care. No treatments will be changed, and no additional tests will be performed.

Who is responsible for this study?

Responsible institution: Saint-Joseph Hospital Foundation, on behalf of Paris Saint-Joseph and Marie Lannelongue Hospitals

Principal Investigator: Dr. Nadia Guezour

Contact: nguezour@ghpsj.fr — Tel.: 01 44 12 85 10

Technical subcontractor: Lifen (data structuring and pseudonymization as part of the LUCC project)

Framework project: LUCC "Lung Cancer" project, led by the Gustave Roussy Cancer Center

Project objective

Background

"Non-small cell" lung cancer is the most common type of lung cancer. In some patients (about 10 to 15 out of 100), the tumor has a specific change (called a mutation) in a gene called EGFR (for “Epidermal Growth Factor Receptor”). This mutation is even more common in people who have never smoked (more than 50 out of 100).

In recent years, a drug called osimertinib (a tablet taken orally once daily) has significantly improved the prognosis for people whose tumors carry this mutation. This treatment helps keep the disease under control for a long period of time.

The problem

Despite its effectiveness, osimertinib eventually loses its ability to control the disease (this is referred to as tumor progression ).

Recent studies have shown that combining osimertinib with chemotherapy (treatment administered as an infusion in a hospital) can delay this progression. However, this combination also causes:

  • More serious adverse effects (64 out of 100 patients, compared with 27 out of 100 with osimertinib alone);
  • Treatment discontinuation in approximately 24 out of 100 patients due to these adverse effects;
  • More frequent hospitalizations and a quality of life that is often diminished.

The research question

Currently, doctors lack a reliable tool to determine which patients would truly benefit from adding chemotherapy and which patients could continue with osimertinib alone while maintaining a good quality of life.

That is precisely the goal of this study: to develop a tool (a scoring system) to help doctors choose the best treatment for each patient.

Main objective

Identify the factors (patient and tumor characteristics) that can predict how long treatment with osimertinib alone will control the disease (known as “progression-free survival”).

The goal is to develop a risk score that can be used to classify patients into two groups:

  • A high-risk group: patients in whom the disease is likely to progress more rapidly with osimertinib alone → these patients may benefit from the addition of chemotherapy.
  • A low-risk group: patients in whom osimertinib alone provides prolonged disease control → these patients could continue to receive osimertinib alone, thereby maintaining their quality of life.

Other objectives

  • Assess patients' overall life expectancy.
  • To understand the mechanisms by which the tumor develops resistance to osimertinib in each group.
  • Analyze the tumor's response to treatment and adverse effects in each group.

Target population

The study includes adults (18 years of age and older) who meet all of the following criteria:

  • Diagnosis: "Non-small cell" lung cancer confirmed by a biopsy, at an advanced stage (metastatic stage, meaning the cancer has spread to other parts of the body).
  • EGFR gene mutation: Presence of a specific EGFR gene mutation, confirmed by molecular biology testing of the tumor sample.
  • Treatment: Must have received first-line treatment with osimertinib alone (tablets) prior to January 1, 2024.
  • No prior treatment: The patient must not have received any other treatment for metastatic disease prior to osimertinib.

This does not include individuals under the age of 18, those with another concurrent cancer, or those who have objected to the reuse of their data.

Data source

This study is retrospective and multicenter (conducted at multiple hospitals). This means that:

  • No new treatments are being tested.
  • No additional tests are performed.
  • Researchers are analyzing existing medical data collected during routine patient follow-up.

The data comes from the LUCC project (a major lung cancer research initiative). Lifen helps transform the information contained in medical records (radiology, laboratory results, consultations, etc.) into structured data that can be used for research, using supervised, non-generative artificial intelligence tools (meaning they do not create new information: they only extract what is already written in the documents). The results produced by these tools are verified by humans.

All data is pseudonymized: your name and contact information are replaced with a code, so researchers cannot directly identify you.

Patients

Why take part in the project?

Some of your medical and administrative data is collected when you are treated in a healthcare facility. This data is useful for the advancement of research.

This research, conducted in the public interest, aims to develop knowledge in order to develop new treatments or improve the overall management of patients suffering from the same disease as you. If you agree to your data being used for this study, you will not have to make any additional visits or undergo any additional examinations.

Only information already in your medical file will be collected. No directly identifying data (surname, first name or contact details) will be included in the cohorts.  

If you wish to object to the processing of your data, you may exercise your rights by informing :

  • your hospital doctor treating you for lung cancer follow-up or ;
  • Lifen's Data Protection Officer at the following address: dpo@lifen.fr ;
  • or by completing the opposition form.

Participating centers

Eleven centers in France are participating in this study as part of the LUCC project:

  1. Gustave Roussy Institute - Villejuif Campus
  2. Paris Saint-Joseph Hospital Group
  3. Foch Hospital (Suresnes)
  4. Saint-Louis Hospital (La Rochelle)
  5. Henri Duffaut Hospital in Avignon
  6. Auxerre Medical Center
  7. André Mignot Hospital in Versailles
  8. Côte de Nacre University Hospital (Caen University Hospital)
  9. Côte Basque Hospital
  10. CHI Aix-en-Provence Campus
  11. CHI Toulon La Seyne-sur-Mer - CH Sainte Musse

How is your data protected?

Protecting your personal data is our top priority. Here are the measures we have in place:

  • Regulatory Framework: This study complies with the General Data Protection Regulation (GDPR) and the French Data Protection Act. It follows the CNIL (Commission Nationale de l'Informatique et des Libertés) reference methodology MR-004, which applies to research not involving human subjects.
  • Pseudonymization: Your data is encrypted. Your name and contact information are never shared with researchers.
  • Encryption: Data is protected by encryption (digital coding) both during transmission and while in storage.
  • Secure hosting: Data is hosted by providers certified as HDS (Health Data Hosts), a rigorous certification required by French regulations. Lifen is also HDS-certified.
  • Traceability: All actions performed on the data are logged to ensure transparency and security.

Does this study affect your treatment?

No. This study has no direct impact on your care:

  • No treatments have been changed.
  • No additional tests are performed.
  • No individual information from the study will be used to change your treatment plan.
  • Under no circumstances may this study be used to stigmatize or discriminate against the individuals or groups included in it.

Are any further studies planned?

If the results of this study make it possible to develop a reliable risk score, future studies could be conducted to:

  • Validate this score in other patient groups and over the long term.
  • To guide treatment decisions between monotherapy with osimertinib and combination therapy with chemotherapy, with the aim of optimizing treatment personalization.

Where can I find more information?

Glossary

EGFR — A gene that, when altered (mutated), can promote the growth of lung cancer cells.

Mutation — A change in a gene that can alter how cells behave.

Osimertinib — An oral medication (tablet) that specifically targets cancer cells carrying a mutation in the EGFR gene.

Chemotherapy — A drug treatment (often administered by infusion) that destroys cancer cells, but can also affect normal cells and cause side effects.

Metastasis — The spread of cancer from its original site to other parts of the body.

Progression-free survival — The length of time during which the disease is under control and does not worsen while the patient is receiving treatment.

Pseudonymization — Replacing names and identifying information with a code to protect patients' identities.

Retrospective study — A study that analyzes medical data collected in the past, without any new intervention.

Risk score — A tool used to assess the likelihood of an event occurring (in this case, disease progression), to help doctors make treatment decisions.

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