Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07177092

PHASE2

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

Sponsor: Jianxing He

View on ClinicalTrials.gov

Summary

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.

Official title: Efficacy and Safety of Primary Tumor Resection Combined With Osimertinib in Patients With Advanced EGFR-mutant Non-small Cell Lung Cancer: A Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

118

Start Date

2025-09-08

Completion Date

2030-12-01

Last Updated

2025-09-16

Healthy Volunteers

Conditions

Non-Small Cell Lung Cancer EGFR

Interventions

PROCEDURE

Surgery

① 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).

DRUG

Osimertinib

Dose: 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.

Inclusion Criteria: 1. Age 18-75 years, no restriction on sex. 2. Histologically or cytologically confirmed stage III-IV non-squamous NSCLC, unresectable as assessed by multidisciplinary team (MDT). 3. Presence of EGFR exon 19 deletion (19Del) or L858R mutation, confirmed by ARMS-PCR, NGS, or other validated methods. 4. No prior systemic therapy for lung cancer. 5. ECOG performance status of 0-1. 6. Estimated life expectancy of at least 6 months. 7. Primary lung tumor size ≥1 cm, with at least one measurable lesion remaining after resection according to RECIST v1.1 criteria. 8. Adequate organ function, including: ① Hematologic function: absolute neutrophil count ≥1.5 × 10⁹/L; platelet count ≥100 × 10⁹/L; hemoglobin ≥9.0 g/dL. ② Hepatic function: ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases are present); total bilirubin ≤1.5 × ULN. ③ Renal function: serum creatinine ≤1.5 × ULN, or creatinine clearance ≥50 mL/min (Cockcroft-Gault formula). 9. Adequate pulmonary function (must meet at least one of the following to ensure postoperative reserve): ① FEV1 ≥1.2 L (or ≥40% of predicted value); ② FEV1/FVC ≥0.7, to exclude severe obstructive ventilatory dysfunction; ③ DLCO (diffusing capacity for carbon monoxide) ≥40% of predicted value, to assess diffusion capacity. ④ If preoperative FEV1 \<1.2 L or DLCO \<40%, additional cardiopulmonary exercise testing (e.g., 6-minute walk test, stair climbing test) is recommended to evaluate postoperative pulmonary reserve. 10. Evaluated by the study team and deemed suitable for primary tumor resection. 11. Signed written informed consent and willingness to comply with study protocol. Exclusion Criteria: 1. Presence of any other known EGFR mutations. 2. Histological evidence of mixed small-cell lung cancer (SCLC) or history of transformation to SCLC. 3. Immunodeficiency: history of primary immunodeficiency disorders, or prior allogeneic organ or bone marrow transplantation. 4. 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. 5. Pregnancy. 6. Any serious comorbid condition that, in the opinion of the investigator, may interfere with participation in the study or interpretation of study results, including but not limited to: uncontrolled systemic diseases, psychiatric illness, active or uncontrolled infections, or other abnormal findings from laboratory or clinical examinations.