The PACE-LUNG trial is a multicenter, non-randomised Phase II study evaluating a treatment intensification strategy with addition of platinum-based doublet chemotherapy to first-line osimertinib in adults with untreated advanced or unresectable locally advanced non-small cell lung cancer (NSCLC) harboring a documented EGFR mutation (exon 19 del or L858R) and with persistent circulating tumor DNA (ctDNA) after approximately three weeks of osimertinib therapy. The primary objective is to assess objective response rate (ORR) and safety of this escalated regimen. Eligible patients are adults with NSCLC stage IIIB/IV, treatment-naïve for systemic therapy, confirmed EGFR mutation, planned osimertinib initiation, and persistent EGFR-mutant ctDNA 21–28 days after osimertinib start. Molecular EGFR status and ctDNA persistence are confirmed at screening. All participants receive osimertinib combined with platinum-based doublet chemotherapy (e.g., cisplatin or carboplatin + pemetrexed). Key secondary endpoints include safety/tolerability, progression-free survival (PFS), overall survival (OS), and duration of response (DOR).
This study investigates whether adding platinum-based doublet chemotherapy to osimertinib in adults with advanced non-small cell lung cancer (NSCLC) and EGFR mutation could improve outcomes, if circulating tumor DNA (ctDNA) remains detectable after about three weeks of osimertinib. The aim is to evaluate whether early treatment intensification leads to better results. Eligible participants are adults with stage IIIB or IV NSCLC and a confirmed EGFR exon 19 deletion or L858R mutation, who have started first-line treatment with osimertinib. The molecular status (EGFR mutation) is confirmed at screening, and persistent ctDNA is used as an inclusion criterion. All participants receive osimertinib combined with platinum-doublet chemotherapy. Key secondary objectives include efficacy (response) and safety/tolerability of the intensified regimen.
