Erlotinib Versus Gemcitabine/Cisplatin as (Neo)Adjuvant Treatment in Non-small Cell Lung Cancer

Summary

Stage IIIA NSCLC represents a relatively heterogeneous group of pts with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of treatment modalities are not clearly defined. Concurrent chemoradiation therapy remains an important treatment for stage IIIA disease, but its treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitor (TKI) may provide a dramatic response in pts with pulmonary adenocarcinoma carrying EGFR activating mutations in the metastatic setting. In the OPTIMAL study, first-line erlotinib versus carboplatin/GEM in advanced NSCLC pts with EGFR activating mutations, the primary analysis showed significantly prolonged progressive free survival (PFS) was with erlotinib vs carboplatin/GEM (p\<0.0001). The aim of this study is to investigate the efficacy and safety of erlotinib versus GEM plus cisplatin (GC) as neoadjuvant treatment in pts with stage IIIA-N2 NSCLC with EGFR activating mutations and to explore a new treatment strategy for this subset.

Conditions

• Non-small Cell Lung Cancer

Interventions

DRUG

Erlotinib

In the neo-adjuvant treatment phase, erlotinib 150 mg/day taken orally for 6 weeks(42 days).In the post-surgery phase, erlotinib 150mg/day taken orally for 1 year or till disease progression or unacceptable toxicity.

DRUG

Gemcitabine/cisplatin

In the neo-adjuvant treatment phase, patient will receive gemcitabine 1250mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 1 of a 3-week schedule for 2 cycles. In the post-surgery phase, Gemcitabine 1250mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 1 of a 3-week schedule for 2 cycles or till disease progression or unacceptable toxicity.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Jilin Provincial Tumor Hospital

  collaborator OTHER

• Jiangsu Cancer Institute & Hospital

  collaborator OTHER

• Zhejiang Cancer Hospital

  collaborator OTHER

• Peking University Cancer Hospital & Institute

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Xi'an Jiaotong University

  collaborator OTHER

• Shanghai Zhongshan Hospital

  collaborator OTHER

• Guangzhou General Hospital of Guangzhou Military Command

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Fujian Medical University Union Hospital

  collaborator OTHER

• Linyi Tumour Hospital

  collaborator OTHER

• Northern Jiangsu People's Hospital

  collaborator OTHER

• Guangdong Association of Clinical Trials

  lead OTHER

Principal Investigators

• Yi-Long WU, MD · Guangdong Lung Cancer Institute

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

• Wen-Zhao ZHONG, MD · Guangdong Lung Cancer Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-05

Primary Completion

2018-04-24

Completion

2022-12-31

Countries

• China

Study Locations