UMIN ID: C000000376
Registered date:31/12/2008
Randomized Phase III Trial Comparing Gefitinib with Carboplatin/Paclitaxel in Previously Untreated Advanced Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor Gene Mutations
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Advanced Non-Small-Cell Lung Cancer with Epidermal Growth Factor Receptor Gene Mutations |
| Date of first enrollment | 2006/04/01 |
| Target sample size | 320 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Gefitinib Carboplatin/Paclitaxel |
Outcome(s)
| Primary Outcome | Progression-free survival |
|---|---|
| Secondary Outcome | Overall survival, response rate, toxicity, Quality of Life |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.With lung fibrosis detectable in chest CT 2.With gefitinib resistant EGFR mutation (T790M) 3.With symptomatic brain metastasis 4.Previous radiotherapy to primary lung cancer 5.With severe co-morbidities 6.With active double cancer |
Related Information
| Primary Sponsor | NEJ Gefitinib Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Self funding |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 022-717-8539 |
| Affiliation | NEJ Gefitinib Study Group Secretariat |
| scientific contact | |
| Name | Toshihiro Nukiwa |
| Address | 1-1, Seiryomachi, Aobaku, Sendai Japan |
| Telephone | |
| Affiliation | Tohoku University School of Medicine Respiratory Medicine |