Ignite Creation Date:
2024-05-05 @ 11:43 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01407822
Status:
UNKNOWN
Last Update Posted:
2018-09-11
First Post:
2011-07-26
Brief Title:
Erlotinib Versus GemcitabineCisplatin as NeoAdjuvant Treatment in Non-small Cell Lung Cancer
Sponsor:
Guangdong Association of Clinical Trials
Organization:
Guangdong Association of Clinical Trials
Study Overview
Official Title:
A National Multi Center Randomized Open-label Phase II Trial of Erlotinib Versus Combination of GC as NeoAdjuvant Treatment in Stage IIIA-N2 NSCLC With Sensitizing EGFR Mutation in Exon 19 or 21EMERGING
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
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 carboplatinGEM in advanced NSCLC pts with EGFR activating mutations the primary analysis showed significantly prolonged progressive free survival PFS was with erlotinib vs carboplatinGEM p00001 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
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 carboplatinpaclitaxel 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 048 95 CI 036 to 064 P0001
In OPTIMAL study first-line erlotinib versus carboplatingemcitabine in Chinese advanced NSCLC patients with EGFR activating mutations the primary analysis showed PFS was significantly prolonged with erlotinib vs carboplatinpaclitaxel131months vs 46 months HR 016 p00001 The objective response rate was significantly improved with erlotinib vs carboplatinpaclitaxel 83 vs 36 p00000 as was the disease control rate CR PR SD 96 vs 82 p0002
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
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 carboplatinpaclitaxel 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 048 95 CI 036 to 064 P0001
In OPTIMAL study first-line erlotinib versus carboplatingemcitabine in Chinese advanced NSCLC patients with EGFR activating mutations the primary analysis showed PFS was significantly prolonged with erlotinib vs carboplatinpaclitaxel131months vs 46 months HR 016 p00001 The objective response rate was significantly improved with erlotinib vs carboplatinpaclitaxel 83 vs 36 p00000 as was the disease control rate CR PR SD 96 vs 82 p0002
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ML25304 | OTHER_GRANT | Roche | None |