Study of Adding Platinum-Based Chemotherapy to Osimertinib for Treating Advanced EGFR-Mutated NSCLC with Persistent Blood Marker at Week 3

What this Trial Is About

Researchers are evaluating a treatment strategy for patients with advanced non-small cell lung cancer NSCLC that have specific EGFR mutations L858R or exon 19 deletions and are starting first-line treatment with osimertinib. This phase II trial focuses on patients who show a poor response to osimertinib alone, as indicated by the continued presence of EGFR mutations in their blood after three weeks of treatment. The purpose is to see if adding platinum-based chemotherapy to osimertinib can improve progression-free survival PFS and overall survival OS compared to historical data. Participants will initially receive standard osimertinib at 80 mg daily. After approximately seven weeks, those with persistent EGFR mutation signals in their plasma will have their treatment escalated by adding up to four cycles of platinum-based chemotherapy, either cisplatin or carboplatin combined with pemetrexed, administered intravenously every three weeks. Patients without persistent EGFR mutations will continue with osimertinib alone and are not eligible for the treatment escalation. This single-arm trial is conducted across multiple centers and is investigator-initiated. Throughout the study, participants will undergo regular assessments including imaging scans and liquid biopsies to monitor disease progression and treatment response. Safety and tolerability of the combined treatment will be evaluated up to 16 weeks after starting chemotherapy, alongside quality of life measurements using questionnaires. The primary outcome is progression-free survival over two years, with overall survival and other secondary outcomes also tracked. Participants are expected to comply with scheduled treatment and follow-up visits for the duration of the study.

Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)