A Randomized Placebo-controlled Phase II Study of Intercalated Administration of Pemetrexed/Cisplatin With Iressa® (Gefitinib) or Placebo as First-line Treatment of Stage IIIB/IV Lung Adenocarcinoma in Never-smokers
Investigators believe this PFS curve crossing-over in both IPASS and First-SIGNAL study is
mainly due to early progression of EGFR mutation-negative tumors after gefitinib alone.
Taken together with the FASTACT trial results, this PFS curve crossing-over may well be
averted if effective chemotherapy is given together with gefitinib in a most optimum timing
and sequence. Apparently, timing of EGFR-TKI administration within chemotherapy cycles is
very critical, as shown in OSI 9774 trial.
In this placebo-controlled randomized phase II, Investigators propose to give gefitinib on
days 5-18 of a 3-weekly chemotherapy cycle of pemetrexed/cisplatin to avoid any potential
overlap of EGFR-TKI effects on chemotherapy or vice versa. Investigators would like to
generate promising pilot data, which warrants a large phase III trial. Investigators hope to
show that intercalated administration of Iressa® (gefitinib) and Pemetrexed/platinum regimen
improves the outcome of never-smokers with advanced (stage IIIB/IV) lung adenocarcinoma.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
To compare progression-free survival
from date of randomization until the date of first documented progression or death from any case. Assessed minimum 1 years.
minimum 1-year follow-up
Jin Soo Lee, M.D. PhD.
National Cancer Center
South Korea: Korea Food and Drug Administration (KFDA)