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

NCT01297101 | Unknown

• 1 other identifier: ML25268(C-TONG1101)
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Non-small Cell Lung Cancer

Interventions

Erlotinib DRUG

150mg/qd, on day 15-28 of each 28 day cycle.

Also known as: Tarceva

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead
• Guangdong Provincial People's Hospital: collaborator
• Shanghai Pulmonary Hospital, Shanghai, China: collaborator

Related Publications (1)

• Chen Z, Shen S, Shi W, Jiang G, Wang X, Jian H, Zhou Z, Ding Z, Lu S. Intercalated combination of chemotherapy and erlotinib for stage IIIA non-small-cell lung cancer: a multicenter, open-label, single-arm, phase II study. Cancer Manag Res. 2019 Jul 12;11:6543-6552. doi: 10.2147/CMAR.S189287. eCollection 2019.

  PMID: 31372055 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 16, 2011
• Last Updated: February 16, 2011

Record last verified: 2011-01