Evaluating Efficacy and Safety of Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Chemotherapy

• Status: Temporarily not available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to investigate the efficacy and safety of Tarceva versus combination of Gemcitabine plus Cisplatin as neoadjuvant treatment in patients with stage IIIA-N1,N2 NSCLC with EGFR activating mutation in exon 19 or 21.

Details

• Lead Sponsor: Shanghai Chest Hospital
• Collaborators: Guangdong General Hospital; Guangdong Provincial People's Hospital; Shanghai Pulmonary Hospital, Shanghai, China
• Treatments: Cisplatin; Erlotinib Hydrochloride; Gemcitabine

Criteria

Inclusion Criteria:

• Pathologically diagnosed of non-small cell lung cancer

• Diagnosed as stage IIIA-NI, N2, except for T4N1M0

• The diagnosis standard of N1 or N2 is as below:

• The short axis of N1 lymph node of Stage IIIA-N1 must be ≥ 10 mm on Computed Tomography, and the Standard Uptake Value (SUV) on PET-CT of N1 lymph node must be > 2.5

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