40
Participants
Start Date
February 22, 2016
Primary Completion Date
May 20, 2019
Study Completion Date
June 22, 2023
Pembrolizumab 200 mg
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Pemetrexed
IV infusion
Folic acid 350-1000 μg
Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.
Vitamin B12 1000 μg
Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.
Dexamethasone 4 mg
For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
Saline solution
IV infusion
National Hospital Organization Nagoya Medical Center ( Site 0324), Nagoya
Kurume University Hospital ( Site 0326), Kurume
Hyogo Cancer Center ( Site 0325), Akashi
Kanazawa University Hospital ( Site 0328), Kanazawa
Kansai Medical University Hospital ( Site 0313), Hirakata
Shizuoka Cancer Center Hospital and Research Institute ( Site 0322), Sunto-gun
National Hospital Organization Shikoku Cancer Center ( Site 0303), Matsuyama
Okayama University Hospital ( Site 0327), Okayama
National Cancer Center Hospital ( Site 0301), Tokyo
The Cancer Institute Hospital of JFCR ( Site 0323), Tokyo
Merck Sharp & Dohme LLC
INDUSTRY