Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients

Launched by SUN YAT-SEN UNIVERSITY · Jun 28, 2017

Keywords

ClinConnect Summary

This clinical trial is investigating two different treatments for patients with a type of lung cancer called non-small cell lung cancer (NSCLC) that can be surgically removed. The goal is to see how effective and safe these treatments are for patients who have specific genetic changes known as EGFR mutations. The treatments being studied are Gefitinib, which is a targeted therapy, and a combination of Oral Navelbine and Carboplatin, which are traditional chemotherapy drugs. The trial aims to find out which treatment can help patients live without cancer for at least two years after their initial treatment.

To participate in this trial, you must have a confirmed diagnosis of stage Ⅱ-ⅢA NSCLC with an EGFR mutation, be in generally good health, and not have received previous treatments like radiation or chemotherapy. The trial is open to adults aged 65 and older. If you qualify and choose to participate, you will receive detailed information about the study and will need to sign a consent form. It's essential to know that this trial is not yet recruiting participants, so it won't be starting immediately.

Gender

ALL

Eligibility 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