Salvage Surgery Following Downstaging of Advanced Non-small Cell Lung Cancer by Targeted Therapy (SDANT)

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of neoadjuvant targeted therapy followed by surgery in participants with advanced non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Osimertinib

Criteria

Inclusion Criteria:

• Pathological diagnosis of NSCLC with confirmed activation of driver gene mutation (EGFR mutant: exon 19 deletion or exon 21 L858R mutation; ALK-rearrangement) by amplification refractory mutation system (ARMS);

• stage IIIB-IV according to the eighth edition of the American Joint Committee on Cancer staging system confirmed by pathological diagnosis and positron emission tomography-computed tomography (PET-CT) and biopsy

• Written informed consent provided；

• Age 18-70 when signing the consent form, both male and female;

• The ECOG score is 0 or 1;

• Adequate hematological function, liver function and renal function;

• Female participants should not be pregnant or breast-feeding.

Exclusion Criteria:

• Previously received systemic anti-tumor therapy for non-small cell lung cancer;

• Subjects who have received chest radiotherapy in the past;

• Known human immunodeficiency virus (HIV) infection;

• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);

• Pregnancy or breast-feeding women;

• Ingredients mixed with small cell lung cancer patients.