Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC patients with EGFR mutation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Dongguan People's Hospital; Maoming Affiliated Hospital of Southern Medical University; Shenzhen People's Hospital; Sixth Affiliated Hospital, Sun Yat-sen University
• Treatments: Carboplatin; Gefitinib; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Pathologic diagnosis of non small cell lung cancer, Stage Ⅱ-ⅢA before treatment

• EGFR Gene mutated

• ECOG 0-1

• liver, kidney and bone marrow are functional healthy，WBC>4.0×109/L，PLT>100×109/L Hb>10g/dL;Cr<1.8mg/dL，bilirubin<1.5mg/dL，GPT<1.5 upper limit of normal

• No vital systems dysfunction or malnutrition

• No other malignant diseases in 5 years（except non melanoma or Cervical carcinoma in situ）

• Have never accepted radiation therapy、overall chemotherapy or biotherapy

• Know the whole protocol，Voluntary participate and sign a consent form

Exclusion Criteria:

• Tumor has violated the surrounding tissue organs（T4）

• Preoperative have evidence of distant metastasis including the contralateral mediastinal lymph nodes

• Arrhythmia need anti-arrhythmic treatment（except for β-blockers or digoxin），Symptomatic coronary artery disease and myocardial ischemia (myocardial infarction) in the past 6 months or more than NYHA class II congestive heart failure

• Adverse drug control severe hypertension

• Moderate to severe proteinuria

• History of HIV infection or activity of chronic hepatitis b or hepatitis c, or other active clinical severe infection

• Cachexy,organ function decompensation

• History of chest radiotherapy

• Not fully control the eye inflammation

• Epilepsy patients needed treatment（such as Steroids or antiepileptic cure）

• Interstitial pneumonia

• Drug abuse and medical, psychological or social conditions may interfere with the patients involved in the research or have an impact on the results of evaluation

• Known or suspected to study drug allergy or to give any drug allergies associated with this test

• Any unstable situation or may endanger the patient safety and compliance

• Fertility and pregnancy or lactation women, and have not been sufficient precautions