Efficacy and Safety Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy (SIIS)
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|ClinicalTrials.gov Identifier: NCT01485809|
Recruitment Status : Unknown
Verified December 2011 by Bong-Seog Kim, Seoul Veterans Hospital.
Recruitment status was: Recruiting
First Posted : December 6, 2011
Last Update Posted : December 6, 2011
Gefitinib was the first epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) approved for the treatment of advanced non-small cell lung cancer (NSCLC). Results from two randomised phase II trials (IDEAL 1 and 2) suggested that gefitinib was efficacious and less toxic, compared with previous results, than was chemotherapy in patients with previously-treated non-small-cell lung cancer. Two phase III trials of gefitinib in advanced non-small-cell lung cancer followed on from the IDEAL phase II studies: Iressa Survival Evaluation in Lung cancer (ISEL) and Iressa NSCLC Trial Evaluating REsponse and Survival versus Taxotere (INTEREST). Although the phase III ISEL trial failed to prove the superiority of gefitinib treatment compared to placebo in previously treated patients, a subgroup analysis demonstrated improved survival in particular populations (Asians and non-smokers). The INTEREST study compared an EGFR tyrosine kinase inhibitor with chemotherapy in pretreated advanced non-small-cell lung cancer. In INTEREST, survival was similar for gefitinib and docetaxel in almost all subgroups; no EGFR-related biomarker or any clinical factor (including female sex, adenocarcinoma histology, never-smoker, and Asian ethnicity) appeared to be predictive of a greater survival benefit for gefitinib versus docetaxel. However, these factors may still be predictive of a greater survival benefit for gefitinib and/or docetaxel versus best supportive care; alternatively, they may just be good prognostic factors. Progression free survival and overall response rate was no statistically significant difference between gefitinib and docetaxel. This suggests gefitinib can provide similar overall survival to docetaxel in pretreated advanced non-small-cell lung cancer patients. These studies have demonstrated that gefitinib is effective for the second-line treatment of NSCLC. Now, gefitinib is recommended in advanced and metastatic NSCLC as second-line chemotherapy.
But, there was no prospective study with gefitinib in NSCLC wih squamous cell histology. This trial will investigate the efficacy and safety of gefitinib in locally advanced, metastatic NSCLC patients with squamous cell histology who have failed first-line chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of Bronchus||Drug: Gefitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||February 2014|
Gefitinib 250mg/day, oral daily q every 4 weeks
Other Name: Iressa
- Disease control rate (complete response, partial response, or stable disease) at 8 weeks [ Time Frame: 8 weeks ]
- number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 2 years ]safety & tolerability: NCI CTCAE version 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485809
|Contact: Taekyu Lim, M.Dfirstname.lastname@example.org|
|Korea, Republic of|
|Seoul Veterans Hospital||Recruiting|
|Seoul, Korea, Republic of, 134-791|
|Contact: Taekyu Lim, M.D +82-2-2225-1599|
|Principal Investigator:||Bong-Seog Kim, M.D||Seoul Veterans Hospital|