Gefitinib Versus Vinorelbine/Platinum as Adjuvant Treatment in Stage II-IIIA(N1-N2) NSCLC With EGFR Mutation

Summary

Activating somatic mutations of the tyrosine kinase domain of epidermal growth factor receptor (EGFR) have been characterized in a subset of patients with advanced NSCLC.The EGFR mutation rate was 30% in Chinese Non-small Cell Lung Cancer(NSCLC). Patients harboring these mutations in their tumors show excellent response to EGFR tyrosine kinase inhibitors (EGFR-TKIs). This randomized phase III trial is studying gefitinib to see how well it works compared to cisplatin-based chemotherapy in treating patients who have undergone surgery for stage II-IIIA(N1-N2) NSCLC with EGFR activating mutation in Asian population.

Conditions

• Non-small Cell Lung Cancer

Interventions

DRUG

Gefitinib

Gefitinib 250 mg/day oral daily

DRUG

Vinorelbine+Cisplatin

Vinorelbine 25 mg/m2 intravenous infusion on day 1 and day 8, Cisplatin 75 mg/m2 on day 1 for 4 cycles

Sponsors & Collaborators

• Guangdong Provincial People's Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Jilin Provincial Tumor Hospital

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• First Hospital of China Medical University

  collaborator OTHER

• Chinese PLA General Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Beijing Chest Hospital

  collaborator OTHER

• 309th Hospital of Chinese People's Liberation Army

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Jiangsu Cancer Institute & Hospital

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Shanghai Pulmonary Hospital, Shanghai, China

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Zhejiang University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• Guangdong Association of Clinical Trials

  lead OTHER

Principal Investigators

• Yi-Long WU, MD · Guangdong Provincial People's Hospital

• Xue-Ning YANG, MD · Guangdong Provincial People's Hospital

• Wen-Zhao ZHONG, MD · Guangdong Provincial People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-19

Primary Completion

2017-03-31

Completion

2020-12-31

Countries

• China

Study Locations