Clinical trial NCT03203590: Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients
Official title: Oral Navelbine Carboplatin Versus Gefitinib Neoadjuvant Therapy for Resectable EGFR Mutation Positive Stage Ⅱ-ⅢA NSCLC, Prospective, Randomized, Multicenter, Phase Ⅲ Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: 2-year Disease-Free Survival
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Shenzhen People's Hospital
name: Dongguan People's Hospital
name: Sixth Affiliated Hospital, Sun Yat-sen University
name: Maoming Affiliated Hospital of Southern Medical University
First posted: 2017-06-29
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 2-year disease free survival
timeFrame: 2 years
Secondary outcomes:
measure: Objective response rate
timeFrame: 1 week before surgery
measure: Pathologic complete response
timeFrame: Within 1 month after surgery
measure: Side effects
timeFrame: 1 week before surgery
measure: Standard uptake value
timeFrame: 1 week before surgery
measure: Tumor reduction rate
timeFrame: Within 1 month after surgery
measure: Mediastinal lymph nodes clearance
timeFrame: Within 1 month after surgery
measure: Postoperative complications
timeFrame: Within 1 month after discharge
measure: R0 resection rate
timeFrame: Within 1 month after surgery
measure: Postoperative mortality rate
timeFrame: Within 1 month after discharge
measure: 5-year overall survival
timeFrame: 5 years after surgery
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Maoming
country: China
facility: Maoming Affiliated Hospital of Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Guowei Ma, MD
role: PRINCIPAL_INVESTIGATOR
References: