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)

Sponsor
Goethe University
Study ID
NCT05281406
Phase
PHASE2
Status
Recruiting
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Conditions

  • NSCLC Stage IIIB
  • NSCLC Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 12, 2021
Status verified
Feb 2025
Primary completion
Nov 30, 2025
Completion
Nov 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Osimertinib in combination with platinum-based chemotherapy
    all patients received a platinum-based chemotherapy (carboplatin/pemetrexed or cisplatin/pemetrexed) for a maximum of 4 cycles (q3w) in combination with 80 mg Osimertinib daily

Primary Outcome Measure

Progression Free Survival (PFS1) [ Time Frame: 2 years ]

Central Contacts

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