Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 3

Conditions: 2-year Disease-Free Survival

Treatments: Drug: Oral Navelbine + Carboplatin; Drug: Gefitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT03203590

3939366

Details and patient eligibility

About

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.

Full description

Lung cancer is the most common cause of cancer mortality in men and women in the world. LACE meta analysis shows that the 5-year survival rate of post-operation chemotherapy group rose by 5.4%, therefore, adjuvant chemotherapy has been the main treatment after surgery according to National Comprehensive Cancer Network (NCCN) Guideline. But patients have poor compliance due to physical condition after surgery. Compared with adjuvant chemotherapy, neoadjuvant therapy has better patient compliance and tolerance.Targeted therapy, with milder side effect compared with chemotherapy, may be a promising choice to treat NSCLC previously. But to date, there is no enough evidence to support the efficacy and safety of neoadjuvant targeted therapy in patients with EGFR mutation.The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy vs Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable NSCLC patients harboring EGFR mutation.

Enrollment: 590 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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590 participants in 2 patient groups

Oral Navelbine + Carboplatin

Active Comparator group

Description:

Neoadjuvant therapy Patients with EGFR mutation will be recruited and treated with Navelbine + Carboplatin.

Treatment:

Drug: Oral Navelbine + Carboplatin

Gefitinib

Experimental group

Description:

Neoadjuvant therapy Patients with EGFR mutation will be recruited and treated with gefitinib.

Treatment:

Drug: Gefitinib