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)

A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 616 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an efficacy and safety study of pembrolizumab (MK-3475) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned to receive pembrolizumab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin). With Amendment 10 (effective date 23-Dec-2019), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded, and all participants in the 'control' arm will discontinue saline placebo. With Amendment 11 (effective date 31-Jan-2022), once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. The primary hypothesis is that pembrolizumab in combination with pemetrexed/platinum chemotherapy prolongs Progression-Free Survival (PFS) and Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.

Conditions

• Non-Small-Cell Lung Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-01-15
• Primary completion: 2017-11-08
• Completion: 2023-06-22
• First posted: 2015-10-19
• Last updated: 2024-09-20
• Results posted: 2018-11-28

Regulatory

• FDA-regulated drug study