Evaluating molecular factors and resistance mechanisms in lung cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on patients with completely resected non-small cell lung cancer (NSCLC) who have common EGFR mutations. It aims to utilize centralized next-generation sequencing (NGS) testing to identify molecular prognostic factors and resistance mechanisms associated with osimertinib treatment. The study will also analyze molecular events linked to relapse after osimertinib exposure, providing insights for optimal treatment strategies in case of metastatic relapse. Patients will be monitored regularly to assess their response to the adjuvant therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed Informed consent.
2. Age ≥ 18 years.
3. Pre-surgical disease evaluation including brain MRI/CT-scan and total body PET-FDG CT-scan prior to surgery.
4. Histologically complete anatomical resection (R0) of stage pIB-IIIA (pTNM 8th edition) NSCLC.
5. Presence of a common EGFR mutation (Del19 or L858R).
6. Archival tumour tissue FFPE blocks from surgery available for centrally molecular analyses.
7. Patient eligible to receive osimertinib adjuvant therapy in a 3-year intent to treat decision; patients could receive if necessary adjuvant chemotherapy before starting osimertinib treatment.
8. Patient who is capable, according to the investigator, of complying with the study's requirements and restrictions.
9. Patient followed in the institution on a regular basis (every 3 to 6 months) according to standard recommendations.
10. Estimated life expectancy \> 3 years.
11. Woman patients who are of childbearing potential are eligible:

    * They must have a negative pregnancy test before the first dose of osimertinib.
    * They must agree to use effective methods of contraception throughout the course of treatment and should be maintained for 2 months after the end of treatment.
12. Male subjects who are sexually active with a woman of childbearing potential are eligible if an efficacious contraception method should be used during the treatment and during the 4 months following the last dose.

Exclusion Criteria:

1. History of cancer, except for the following situations:

   Patients with history of cancer for more than 3 years are eligible if they have been treated and considered cured. Patients with history of in situ carcinoma of the cervix or non-melanoma skin carcinoma are eligible.
2. Neoadjuvant anti-cancer treatment (osimertinib and/or chemotherapy or other anti-cancer treatment).
3. Incompletely resected NSCLC (R1 or R2).
4. Any medical condition that would, according to the investigator's judgment, prevent the patient's participation in the clinical study.
5. Active infection (e.g. patients receiving treatment for infection) including hepatitis C virus (HCV) and human immunodeficiency virus (HIV), or active uncontrolled hepatitis B infection except for the situations described in APPENDIX I. Screening for chronic conditions is not required.

Where it's running

• Angers - CHU
  Angers, France Recruiting
• Bayonne - CH
  Bayonne, France Recruiting
• Boulogne - Ambroise Paré
  Boulogne, France Recruiting
• Lyon - URCOT
  Bron, France Recruiting
• Caen - CHU
  Caen, France Recruiting
• Clermont-Ferrand - CHU
  Clermont-Ferrand, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.