Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients

2-year Disease-Free Survival Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03203590
• Other study ID #: 3939366
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 21, 2017
• Last updated: June 28, 2017
• Start date: September 2017
• Est. completion date: January 2026

Study information

• Verified date: June 2017
• Source: Sun Yat-sen University
• Contact: Guowei Ma, MD
• Phone: 13501546669
• Email: magw[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 590
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Pathologic diagnosis of non small cell lung cancer, Stage ?-?A 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 ß-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

Related Conditions & MeSH terms

• 2-year Disease-Free Survival

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	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

Sponsors (5)

Lead Sponsor	Collaborator
Sun Yat-sen University	Dongguan People's Hospital, Maoming Affiliated Hospital of Southern Medical University, Shenzhen People's Hospital, Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year disease free survival		2 years
Secondary	Objective response rate		1 week before surgery
Secondary	Pathologic complete response		Within 1 month after surgery
Secondary	Side effects		1 week before surgery
Secondary	Standard uptake value		1 week before surgery
Secondary	Tumor reduction rate		Within 1 month after surgery
Secondary	Mediastinal lymph nodes clearance		Within 1 month after surgery
Secondary	Postoperative complications		Within 1 month after discharge
Secondary	R0 resection rate		Within 1 month after surgery
Secondary	Postoperative mortality rate		Within 1 month after discharge
Secondary	5-year overall survival		5 years after surgery