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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Goethe University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hypothesize, that in patients with on-label osimertinib 1st-line treatment of stage IIIB or IV NSCLC, a biomarker-driven escalation of osimertinib therapy with a platinum-based chemotherapy regimen will effectively enhance PFS and subsequently OS. Lack of EGFRm clearance after an osimertinib treatment period of 3 weeks as assessed by liquid biopsy will be used to predict sub-optimal response. In these patients, treatment will be escalated after approx. 7 weeks of on-label osimertinib monotherapy by adding up to 4 cycles of a combination regimen of pemetrexed and cisplatin or carboplatin. Patients with complete EGFR plasma clearance will continue to receive standard of care osimertinib and will not be eligible for the study. Primary outcome measure will be PFS, which will be compared to historical data on TKI monotherapy from persistent EGFR shedder from the FLAURA trial.

Conditions

• NSCLC Stage IIIB
• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	Osimertinib	80 mg daily or reduced dose 40 mg daily
DRUG	Pemetrexed	500 mg/m² i.v. d1 of every 21-day cycle for a maximum of 4 cycles
DRUG	Cisplatin	75mg/m² i.v. d1 of every 21-day cycle for a maximum of 4 cycles
DRUG	Carboplatin	AUC 5 mg/mL/min i.v. d1 of every 21-day cycle for a maximum of 4 cycles

Timeline

• Start date: 2021-11-12
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2022-03-16
• Last updated: 2025-02-21

Locations

16 sites across 1 country: Germany