Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients

NCT ID: NCT03203590

Last Updated: 2017-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 590 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2026-01-31

Brief 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.

Detailed 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.

Conditions

2-year Disease-Free Survival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Navelbine + Carboplatin

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

Group Type: ACTIVE_COMPARATOR

Oral Navelbine + Carboplatin

Intervention Type: DRUG

The patient will be given Navelbine 60 mg/m2, p.o. day 1 and 8 of every cycle (21 days) plus carboplatin AUC 5, i.v. day 1 of every cycle.After 2 cycle we will evaluate their clinical response.Then operable patients will have surgery.

Gefitinib

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

Group Type: EXPERIMENTAL

Gefitinib

Intervention Type: DRUG

The patient will be given Gefitinib 250mg,p.o.,q.d. for 8 weeks.After 8 weeks we evaluate their clinical response.Then operable patients will have surgery.

Interventions

Oral Navelbine + Carboplatin

The patient will be given Navelbine 60 mg/m2, p.o. day 1 and 8 of every cycle (21 days) plus carboplatin AUC 5, i.v. day 1 of every cycle.After 2 cycle we will evaluate their clinical response.Then operable patients will have surgery.

Intervention Type: DRUG

Gefitinib

The patient will be given Gefitinib 250mg,p.o.,q.d. for 8 weeks.After 8 weeks we evaluate their clinical response.Then operable patients will have surgery.

Intervention Type: DRUG

Other Intervention Names

Vinorelbine; Carboplat; Iressa

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen People's Hospital

OTHER

Sponsor Role: collaborator

Dongguan People's Hospital

OTHER_GOV

Sponsor Role: collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Maoming Affiliated Hospital of Southern Medical University

UNKNOWN

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Guowei Ma

Professor,Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guowei Ma, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Dongguan People's Hospital

Dongguan, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Maoming Affiliated Hospital of Southern Medical University

Maoming, Guangdong, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Countries

China

Central Contacts

Guowei Ma, MD

Role: CONTACT

Phone: 13501546669

Email: magw@sysucc.org.cn

Facility Contacts

Jianping Zhou, MD

Role: primary

Guowei Ma, MD

Role: primary

Jinming Zhao, MD

Role: primary

Jiang Huang, MD

Role: primary

Guangsuo Wang, MD

Role: primary

Other Identifiers

3939366

Identifier Type: -

Identifier Source: org_study_id