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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Cisplatin; Erlotinib Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

• Written informed consent provided.

• Males or females aged ≥18 years.

• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

• Pathologically diagnosed of non-small cell lung cancer.

• Diagnosed as stage IIIA- N2.The diagnosis standard of N2 is as below: Pts with resectable stage IIIA-N2 NSCLC confirmed by mediastinoscopy or EBUS or PET/CT.

• EGFR activating mutation in exon 19 or 21 by the biopsy of primary tumor or N2 lymph node.

• Measurable disease must be characterized according to RECIST 1.1 criteria.

• Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10mm by spiral CT or MRI scan. The measurable criteria of lymph node is the short axis ≥ 15 mm.

• ECOG performance status 0-1.

• Life expectancy ≥12 weeks.

• Adequate hematological function:Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).

• Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.

• Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.

• Female subjects should not be pregnant or breast-feeding.

Exclusion Criteria:

• Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).

• Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).

• Resection of primary malignancy.

• EGFR mutation (exon 19 or 21) negative or unknown.

• Uncontrolled central nervous system (CNS) metastasis.

• History of another malignancy in the last 5 years with the exception of the following:Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted; Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.

• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

• Known hypersensitivity to Tarceva or gemcitabine or cisplatin.

• Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.

• Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.