Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)

PHASE3CompletedINTERVENTIONAL
Enrollment

616

Participants

Timeline

Start Date

January 15, 2016

Primary Completion Date

November 8, 2017

Study Completion Date

June 22, 2023

Conditions
Non-Small-Cell Lung Carcinoma
Interventions
BIOLOGICAL

Pembrolizumab 200 mg

IV infusion

DRUG

Cisplatin

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Pemetrexed

IV infusion

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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.

DRUG

Dexamethasone 4 mg

For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.

DRUG

Saline solution

IV infusion

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02578680 - Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189) | Biotech Hunter | Biotech Hunter