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

Expanded access is temporarily not available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01297101
First Posted: February 16, 2011
Last Update Posted: February 16, 2011
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.
Collaborators:
Guangdong General Hospital
Shanghai Pulmonary Hospital, Shanghai, China
Information provided by:
Shanghai Chest Hospital
February 15, 2011
February 16, 2011
February 16, 2011
 
Evaluating Efficacy and Safety of Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Chemotherapy
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.

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.

Expanded Access
Drug: Erlotinib
150mg/qd, on day 15-28 of each 28 day cycle.
Other Name: Tarceva
Not Provided
 
Temporarily not available
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01297101
Lu Shun / Profess, Shanghai Chest Hospital
Shanghai Chest Hospital
  • Guangdong General Hospital
  • Shanghai Pulmonary Hospital, Shanghai, China
Not Provided
Shanghai Chest Hospital
January 2011