Overview

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