Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients

June 28, 2017 updated by: Guowei Ma, Sun Yat-sen University

Oral Navelbine Carboplatin Versus Gefitinib Neoadjuvant Therapy for Resectable EGFR Mutation Positive Stage Ⅱ-ⅢA NSCLC, Prospective, Randomized, Multicenter, Phase Ⅲ Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
590

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Dongguan, Guangdong, China, 523000
        • Dongguan People's Hospital
        • Contact:
          • Jianping Zhou, MD
      • Guangzhou, Guangdong, China, 510000
        • Sun yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Guowei Ma
      • Guangzhou, Guangdong, China, 510000
        • The sixth affiliated hospital of Sun Yat-Sen University
        • Contact:
          • Jinming Zhao, MD
      • Maoming, Guangdong, China, 525000
        • Maoming Affiliated Hospital of Southern Medical University
        • Contact:
          • Jiang Huang, MD
      • Shenzhen, Guangdong, China, 518000
        • ShenZhen People's Hospital
        • Contact:
          • Guangsuo Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Oral Navelbine + Carboplatin
Neoadjuvant therapy Patients with EGFR mutation will be recruited and treated with Navelbine + Carboplatin.
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.
Other Names:
  • Carboplat
  • Vinorelbine
Experimental: Gefitinib
Neoadjuvant therapy Patients with EGFR mutation will be recruited and treated with gefitinib.
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.
Other Names:
  • Iressa

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
2-year disease free survival
Time Frame: 2 years
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Objective response rate
Time Frame: 1 week before surgery
1 week before surgery
Pathologic complete response
Time Frame: Within 1 month after surgery
Within 1 month after surgery
Side effects
Time Frame: 1 week before surgery
1 week before surgery
Standard uptake value
Time Frame: 1 week before surgery
1 week before surgery
Tumor reduction rate
Time Frame: Within 1 month after surgery
Within 1 month after surgery
Mediastinal lymph nodes clearance
Time Frame: Within 1 month after surgery
Within 1 month after surgery
Postoperative complications
Time Frame: Within 1 month after discharge
Within 1 month after discharge
R0 resection rate
Time Frame: Within 1 month after surgery
Within 1 month after surgery
Postoperative mortality rate
Time Frame: Within 1 month after discharge
Within 1 month after discharge
5-year overall survival
Time Frame: 5 years after surgery
5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shenzhen People's Hospital
Sixth Affiliated Hospital, Sun Yat-sen University
Dongguan People's Hospital
Maoming Affiliated Hospital of Southern Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guowei Ma, MD, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3939366

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on 2-year Disease-Free Survival

Clinical Trials on Oral Navelbine + Carboplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings