Erlotinib Versus Gemcitabine/Cisplatin as (Neo)Adjuvant Treatment in Non-small Cell Lung Cancer
Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Guangdong Association of Clinical Trials
Collaborators:
Beijing Cancer Hospital Fujian Medical University Fujian Medical University Union Hospital Guangdong General Hospital Guangdong Provincial People's Hospital Guangzhou General Hospital of Guangzhou Military Command Health Science Center of Xi'an Jiaotong University Health Science Center of Xi’an Jiaotong University Jiangsu Cancer Institute & Hospital Jilin Provincial Tumor Hospital Linyi Tumour Hospital Northern Jiangsu Province People's Hospital Peking University People's Hospital Shanghai Chest Hospital Shanghai Zhongshan Hospital Sun Yat-sen University The First Affiliated Hospital of Dalian Medical University The First Affiliated Hospital of Guangzhou Medical University Tianjin Medical University Cancer Institute and Hospital West China Hospital Zhejiang Cancer Hospital