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Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer

NCT07738172 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-08-07

No results posted yet for this study

Summary

Osimertinib is a standard first-line treatment for patients with metastatic non-small cell lung cancer harboring an epidermal growth factor receptor exon 19 deletion or exon 21 L858R mutation. Although osimertinib can provide effective disease control, most patients eventually experience disease progression, and the primary lung tumor may remain an important site of treatment resistance.

This multicenter, randomized, open-label phase III trial will evaluate whether surgical removal of the primary lung tumor, in addition to continued osimertinib treatment, prolongs progression-free survival in patients with EGFR-mutated oligometastatic non-small cell lung cancer.

All participants will initially receive osimertinib 80 mg orally once daily for 12 weeks. Participants who have a partial response or stable disease according to RECIST version 1.1 and remain suitable for surgery will be randomly assigned in a 1:1 ratio to continue osimertinib alone or to undergo primary lung tumor resection followed by resumption of osimertinib. The study will also evaluate overall survival, safety, pathologic response, quality of life, patterns of disease progression, and changes in molecular biomarkers.

Conditions

  • Lung Neoplasms, Non-Small Cell Lung Cancer

Interventions

PROCEDURE

Primary Tumor Resection

Participants assigned to the experimental arm will undergo therapeutic resection of the primary lung tumor after randomization. Acceptable procedures include lobectomy, sleeve lobectomy, bilobectomy, segmentectomy, and wedge resection. The surgical approach may include video-assisted thoracic surgery or thoracotomy. Pneumonectomy and sleeve pneumonectomy are not permitted. The procedure is intended to achieve maximal regional disease control and tumor-free resection margins whenever feasible.

DRUG

Osimertinib

Osimertinib will be administered orally at a dose of 80 mg once daily as first-line systemic therapy. Treatment will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or fulfillment of other protocol-defined discontinuation criteria. Dose interruption or reduction will be permitted for treatment-related adverse events according to the study protocol.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Chong-Jen Yu, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2031-08-01
Completion
2031-08-01

Countries

  • Taiwan

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 NCT07738172 on ClinicalTrials.gov