Osimertinib and Etoposide as First-Line Treatment in Osimertinib-Resistant Advanced EGFR-Mutant NSCLC

Launched by DAPING HOSPITAL AND THE RESEARCH INSTITUTE OF SURGERY OF THE THIRD MILITARY MEDICAL UNIVERSITY · May 28, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation called EGFR. While the standard treatment, osimertinib, works well for many patients, some still experience resistance after a few months. This study will combine osimertinib with another drug called etoposide to see if this combination can help those who are resistant to osimertinib. The goal is to improve outcomes for patients with stage IIIB or IV NSCLC who have not had success with osimertinib alone.

To be eligible for this trial, participants need to be between 18 and 79 years old and have been diagnosed with locally advanced (stage IIIB) or metastatic (stage IV) EGFR-mutant NSCLC. They should have already received at least two cycles of osimertinib and showed either stable disease or slow progression. Participants will be closely monitored for their response to the treatment, and they should expect to undergo regular check-ups and tests to measure the effectiveness of the therapy. It’s important to note that individuals currently receiving other cancer treatments or those with certain health conditions may not be eligible for this study.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 to 79 years.
• • 2. Locally advanced (stage IIIB) or metastatic (stage IV) EGFR-mutant NSCLC.
• • 3. Harboring an EGFR sensitizing mutation (Exon 19 deletion or L858R).
• • 4. Received at least two cycles of first-line osimertinib treatment, with a best response of stable disease or slow progression.
• • 5. Life expectancy greater than 3 months.
• 6. At least one measurable tumor lesion meeting the following criteria:
• • 1.No prior radiation therapy; 2.Measurable by chest CT or PET-CT, with a longest diameter ≥ 10 mm at baseline (short axis ≥ 15 mm for lymph nodes); 3.Amenable to accurate repeated measurements.
• Exclusion Criteria:
• • 1. Currently receiving or planning to receive other anti-cancer therapies.
• • 2. Having contraindications to osimertinib or etoposide.
• • 3. Harboring known targetable osimertinib resistance mechanisms.