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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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-02-21

No results posted yet for this study

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.

Conditions

  • NSCLC Stage IIIB
  • NSCLC Stage IV

Interventions

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

Sponsors & Collaborators

  • Goethe University

    lead OTHER

Principal Investigators

  • Martin Sebastian, MD · Goethe University Frankfurt

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-12
Primary Completion
2025-11-30
Completion
2026-11-30

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05281406 on ClinicalTrials.gov