Evaluating Efficacy and Safety of Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Chemotherapy
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Purpose
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 | Intervention |
|---|---|
|
Non-small Cell Lung Cancer |
Drug: Erlotinib |
| Study Type: | Expanded Access What is 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 |
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Drug: Erlotinib
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Lu Shun / Profess, Shanghai Chest Hospital |
| ClinicalTrials.gov Identifier: | NCT01297101 History of Changes |
| Other Study ID Numbers: | ML25268(C-TONG1101) |
| Study First Received: | February 15, 2011 |
| Last Updated: | February 15, 2011 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Cisplatin Erlotinib Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013