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Evaluating molecular factors and resistance mechanisms in lung cancer treatment

A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19)

Not applicable Interventional Intergroupe Francophone de Cancerologie Thoracique · NCT06053099

This study is testing how well a specific lung cancer treatment works for patients with certain gene mutations and aims to find out why some patients might not respond to the treatment or have a relapse.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorIntergroupe Francophone de Cancerologie Thoracique Academic / other
Drugs / interventionsosimertinib, chemotherapy
Locations36 sites (Angers and 35 other locations)
Trial IDNCT06053099 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with completely resected stage pIB-IIIA NSCLC and confirmed common EGFR mutations.

Not a fit: Patients with non-EGFR mutations or those who have not undergone complete surgical resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with NSCLC, enhancing their chances of long-term survival.

How similar studies have performed: Previous studies have shown promise in using molecular profiling to guide treatment in lung cancer, suggesting that this approach may yield beneficial results.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Angers and 35 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non Small Cell Lung CancerEGFR Activating MutationEGFR DEL19EGFR L858RIFCTNSCLCAdjuvant Osimertinib
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.