Erlotinib Versus Gemcitabine/Cisplatin as (Neo)Adjuvant Treatment in Non-small Cell Lung Cancer (EMERGING)
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First Received Date ICMJE | July 26, 2011 | ||||||||||||
Last Updated Date | August 1, 2011 | ||||||||||||
Start Date ICMJE | July 2011 | ||||||||||||
Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
The objective response rate (ORR) in neoadjuvant treatment [ Time Frame: Tumor response will be evaluated after 6 weeks of induction treatment (during day 43 to day 49). ] [ Designated as safety issue: No ] To evaluate objective response rate (ORR) of Erlotinib versus combination of Gemcitabine plus Cisplatin as neoadjuvant treatment for stage IIIA- N2 NSCLC with EGFR activating mutation in exon 19 or 21. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT01407822 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Erlotinib Versus Gemcitabine/Cisplatin as (Neo)Adjuvant Treatment in Non-small Cell Lung Cancer | ||||||||||||
Official Title ICMJE | A National, Multi Center, Randomized, Open-label, Phase II Trial of Erlotinib Versus Combination of Gemcitabine Plus Cisplatin as (Neo)Adjuvant Treatment in Stage IIIA-N2 Non-small-cell Lung Cancer With Sensitizing EGFR Mutation in Exon 19 or 21(EMERGING) | ||||||||||||
Brief Summary | Stage IIIA NSCLC represents a relatively heterogeneous group of pts with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of treatment modalities are not clearly defined. Concurrent chemoradiation therapy remains an important treatment for stage IIIA disease, but its treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitor (TKI) may provide a dramatic response in pts with pulmonary adenocarcinoma carrying EGFR activating mutations in the metastatic setting. In the OPTIMAL study, first-line erlotinib versus carboplatin/GEM in advanced NSCLC pts with EGFR activating mutations, the primary analysis showed significantly prolonged progressive free survival (PFS) was with erlotinib vs carboplatin/GEM (p<0.0001). The aim of this study is to investigate the efficacy and safety of erlotinib versus GEM plus cisplatin (GC) as neoadjuvant treatment in pts with stage IIIA-N2 NSCLC with EGFR activating mutations and to explore a new treatment strategy for this subset. |
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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 pts. 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. In IPASS study (gefitinib or carboplatin/paclitaxel in pulmonary adenocarcinoma as first line treatment), the subgroup of 261 patients who were positive for the epidermal growth factor receptor gene (EGFR) mutation, progression-free survival was significantly longer among those who received gefitinib than among those who received carboplatin-paclitaxel (hazard ratio for progression or death, 0.48; 95% CI, 0.36 to 0.64; P<0.001). In OPTIMAL study (first-line erlotinib versus carboplatin/gemcitabine in Chinese advanced NSCLC patients with EGFR activating mutations), the primary analysis showed PFS was significantly prolonged with erlotinib vs carboplatin/paclitaxel(13.1months vs 4.6 months, HR 0.16 ; p<0.0001). The objective response rate was significantly improved with erlotinib vs carboplatin/paclitaxel (83% vs 36%, p=0.0000), as was the disease control rate (CR + PR + SD; 96 vs 82%; p=0.002). 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- N2 NSCLC with EGFR activating mutation in exon 19 or 21. |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Non-small Cell Lung Cancer | ||||||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||
Estimated Enrollment ICMJE | 90 | ||||||||||||
Estimated Completion Date | March 2016 | ||||||||||||
Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||
Ages | 18 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE |
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Location Countries ICMJE | China | ||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT01407822 | ||||||||||||
Other Study ID Numbers ICMJE | C-TONG 1103, ML25304 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
Responsible Party | Yi-Long WU/Chinese Thoracic Oncology Group, Chinese Thoracic Oncology Group | ||||||||||||
Study Sponsor ICMJE | Guangdong Association of Clinical Trials | ||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | Guangdong Association of Clinical Trials | ||||||||||||
Verification Date | August 2011 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |