Primary Tumor Resection Plus Osimertinib in Advanced EGFR-mutant Non-small Cell Lung Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJianxing He

About this trial

This study is designed to explore whether resecting the primary lung cancer, followed by osimertinib, can improve outcomes for patients with advanced non-small cell lung cancer (NSCLC) harboring sensitizing EGFR mutations (exon 19 deletion or L858R). Patients with stage III-IV NSCLC will be included and randomly assigned to receive either surgery to remove the primary lung cancer followed by osimertinib, or osimertinib alone. All patients will continue treatment until disease progression or they need to stop for another reason. The primary outcome being studied is progression-free survival (PFS). Secondary outcomes include overall survival (OS), objective response rate (ORR), disease control rate (DCR), adverse effects (AEs), serious adverse effects (SAEs) and quality of life (QoL). The findings from this study may help determine whether surgery combined with EGFR tyrosine kinase inhibitor (TKI) provides more benefit than EGFR-TKI alone for patients with EGFR-mutant advanced NSCLC.

Eligibility criteria

Qualifiers

Age 18-75 years, no restriction on sex.

Histologically or cytologically confirmed stage III-IV non-squamous NSCLC, unresectable as assessed by multidisciplinary team (MDT).

Presence of EGFR exon 19 deletion (19Del) or L858R mutation, confirmed by ARMS-PCR, NGS, or other validated methods.

No prior systemic therapy for lung cancer.

Disqualifiers

Presence of any other known EGFR mutations.

Histological evidence of mixed small-cell lung cancer (SCLC) or history of transformation to SCLC.

Immunodeficiency: history of primary immunodeficiency disorders, or prior allogeneic organ or bone marrow transplantation.

Active brain metastases. Patients with adequately treated brain metastases may be eligible if they are neurologically stable for at least 2 weeks before enrollment, and are either not requiring corticosteroids or receiving a stable or decreasing dose of ≤10 mg prednisone (or equivalent) once daily.

Trial design

Treatments tested in this trial

  • Surgery
  • Osimertinib

Treatment groups

118 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Jianxing He

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Sponsor institution