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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01297101
Expanded Access Status : Temporarily not available
First Posted : February 16, 2011
Last Update Posted : February 16, 2011
Guangdong Provincial People's Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Information provided by:
Shanghai Chest Hospital

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.

Condition or disease Intervention/treatment
Non-small Cell Lung Cancer Drug: Erlotinib

Detailed Description:

Concurrent Chemoradiation therapy remain the standard treatment for stage IIIA disease, but its treatment-related life threaten toxicity limit its use for those patients.

Tarceva monotherapy have been demonstrated a significant improvement in overall survival and disease progression free survival when used for the treatment of patients with metastatic NSCLC, after failure of at least one prior chemotherapy regimen. It is well tolerated without the side effects usually associated with chemotherapy.

Based on the encouraging results reported from the SLCG phase II study reported the efficacy of Tarceva as first line treatment for metastatic NSCLC with EGFR mutation patients would prolong overall survival, delay disease progression and be well tolerated, mOS reached 27 months, ORR reached 71%. Besides, with different mechanism and more tolerable than chemo, Tarceva may provide an important treatment alternative for local advanced pts with EGFR mutation.

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Study Type : Expanded Access
Official Title: A National, Multi Center, Randomized, Open-label, Phase II Trial of Tarceva Versus Combination of Gemcitabine Plus Cisplatin as Neoadjuvant Treatment in Stage IIIA-N1,N2 NSCLC With Activating EGFR Mutation in Exon 19 or 21

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Erlotinib
    150mg/qd, on day 15-28 of each 28 day cycle.
    Other Name: Tarceva

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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

No Contacts or Locations Provided
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lu Shun / Profess, Shanghai Chest Hospital Identifier: NCT01297101    
Other Study ID Numbers: ML25268(C-TONG1101)
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: February 16, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action