drugset / Trial / NCT05281406

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)

NCT05281406

Phase 2 Recruiting 50 enrolled Goethe University
NaSingle-groupOpen-labelTreatment

Summary

PACE is a prospective multicenter single-arm investigator-initiated phase II trial that examines the value of a treatment escalation strategy by the addition of platinum-based doublet chemotherapy to osimertinib in patients with treatment-naïve NSCLC harboring L858R or del19 EGFR mutation who are suspected to have poor response upon single-agent TKI treatment.

Timeline

Start
2021-11-12
Primary completion
2025-11
Completion
2026-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Osimertinib Small molecule 40 mg
Subject Osimertinib Small molecule 80 mg
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous