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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Surgery
Procedure/Surgery① Preoperative evaluation must confirm resectability. Thoracoscopic minimally invasive surgery will be performed, with the surgical approach selected according to disease conditions, such as lobectomy, segmentectomy, wedge resection, or sleeve resection; ② Systematic mediastinal lymph node dissection or lymph node sampling (based on preoperative imaging and intraoperative evaluation) must be performed; ③ Postoperative recovery must be adequate (postoperative complications ≤ Clavien-Dindo grade II).
Osimertinib
DrugDose: 80 mg orally, once daily, until disease progression or the occurrence of unacceptable toxicity. The dose should be administered at approximately the same time each day, at 24-hour intervals.
Treatment groups
118 Participants
are divided into 2 treatment groupsGroup A: Control GroupActive comparator 1 intervention
Group B: Intervention GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Progression-free Survival
Progression-free survival is defined as the time from randomization to the first documentation of disease progression or death from any cause, whichever occurs first. Disease progression will be assessed by the Independent Radiology Review Committee according to RECIST version 1.1 criteria.
Time frame
From randomization until the first documentation of disease progression or death from any cause, whichever occurs first (up to 5 years).Secondary outcomes
1
Overall Survival
Overall survival is defined as the time from randomization to death from any cause.
Time frame
Randomization to death from any cause (up to 5 years).2
Objective Response Rate
The proportion of patients achieving complete and partial remission after treatment, measured according to RECIST v1.1 criteria.
Time frame
Randomization until disease progression or death, which ever occurs first (up to 5 years).3
Disease Control Rate
Disease control rate is defined as the proportion of participants with complete response, partial response, and stable disease, as determined by RECIST v1.1 criteria.
Time frame
Randomization until disease progression or death, which ever occurs first (up to 5 years).4
Adverse Events
Safety will be assessed by recording treatment-related adverse events (AEs) and serious adverse events (SAEs), graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame
From randomization to disease progression or death (up to 5 years).Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jianxing He
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Sponsor institution
Source ClinicalTrials.gov
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