OncoMatch/Clinical Trials/NCT07738172
Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer
Official title: A Multicenter, Randomized Controlled Phase III Clinical Trial of Primary Tumor Resection in Patients With Oligometastatic EGFR-Mutant Non-Small Cell Lung Cancer After EGFR-Targeted Therapy
Is NCT07738172 recruiting? Yes, currently enrolling (Oct 2026). This Phase 3 trial studies Osimertinib for lung neoplasms, non-small cell lung cancer.
Treatment: Osimertinib — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
Required: EGFR l858r
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
WHO 0–1
Prior therapy
Must have received: EGFR tyrosine kinase inhibitor (osimertinib) — first-line induction for stage IV NSCLC
The subject has received first-line protocol-defined osimertinib induction according to the study protocol, consisting of osimertinib once daily (QD) for 12 weeks
Cannot have received: systemic anticancer therapy for current stage IV NSCLC
Exception: protocol-defined osimertinib induction
Any prior EGFR-TKI, chemotherapy, immunotherapy, or other systemic anticancer therapy for the current stage IV NSCLC, except for the protocol-defined osimertinib induction
Cannot have received: systemic therapy for current stage IV NSCLC
Exception: protocol-defined osimertinib induction
Any systemic therapy other than the protocol-defined osimertinib induction for the current stage IV NSCLC
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07738172 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy for current stage IV NSCLC, systemic therapy for current stage IV NSCLC disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR l858r is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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