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Clinical Trial of Neoadjuvant Targeted Treatment to NSCLC Patients

NCT03203590 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 590

Last updated 2017-06-29

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Shenzhen People's Hospital

    collaborator OTHER

  • Dongguan People's Hospital

    collaborator OTHER_GOV

  • Sixth Affiliated Hospital, Sun Yat-sen University

    collaborator OTHER

  • Maoming Affiliated Hospital of Southern Medical University

    collaborator UNKNOWN

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Guowei Ma, MD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03203590 on ClinicalTrials.gov