Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients

NCT03203590 | Unknown Phase 3 DMC

• 1 other identifier: 3939366
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 5

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.

Conditions

2-year Disease-Free Survival

Outcome Measures

Primary Outcomes (1)

• 2-year disease free survival

  2 years

Secondary Outcomes (10)

• Objective response rate

  1 week before surgery

• Pathologic complete response

  Within 1 month after surgery

• Side effects

  1 week before surgery

• Standard uptake value

  1 week before surgery

• Tumor reduction rate

  Within 1 month after surgery

Study Arms (2)

Oral Navelbine + Carboplatin

ACTIVE COMPARATOR

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

Drug: Oral Navelbine + Carboplatin

Gefitinib

EXPERIMENTAL

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

Drug: Gefitinib

Interventions

Oral Navelbine + Carboplatin 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.

Also known as: Vinorelbine, Carboplat

Oral Navelbine + Carboplatin

Gefitinib 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.

Also known as: Iressa

Gefitinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Shenzhen People's Hospital: collaborator
• Dongguan People's Hospital: collaborator
• Sixth Affiliated Hospital, Sun Yat-sen University: collaborator
• Maoming Affiliated Hospital of Southern Medical University: collaborator

Study Sites (5)

Dongguan People's Hospital

Dongguan, Guangdong, 523000, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Maoming Affiliated Hospital of Southern Medical University

Maoming, Guangdong, 525000, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Interventions

Vinorelbine; Carboplatin; Gefitinib

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Coordination Complexes; Organic Chemicals; Quinazolines

Study Officials

• Guowei Ma, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guowei Ma, MD

CONTACT

13501546669; magw@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor,Chief Physician

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 29, 2017
• Study Start: September 1, 2017
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: June 29, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (5)