Efficacy and Safety Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy
Status:
Unknown status
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
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.