Status:
NOT_YET_RECRUITING
Primary Tumor Resection Plus Osimertinib in Advanced EGFR-mutant Non-small Cell Lung Cancer
Lead Sponsor:
Jianxing He
Conditions:
Non-Small Cell Lung Cancer
EGFR
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 sensi...
Detailed Description
Osimertinib is a third-generation EGFR-TKI that has become one of the standard first-line treatments for patients with advanced NSCLC harboring sensitizing EGFR mutations such as exon 19 deletion and ...
Eligibility Criteria
Inclusion
- 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.
- ECOG performance status of 0-1.
- Estimated life expectancy of at least 6 months.
- Primary lung tumor size ≥1 cm, with at least one measurable lesion remaining after resection according to RECIST v1.1 criteria.
- 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).
- 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.
- Evaluated by the study team and deemed suitable for primary tumor resection.
- Signed written informed consent and willingness to comply with study protocol.
Exclusion
- 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.
- Pregnancy.
- 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.
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT07177092
Start Date
September 8 2025
End Date
December 1 2030
Last Update
September 16 2025
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