trialsTrialActive

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension

A phase 3 trial of Pemetrexed, Cisplatin, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension is a phase 3 interventional study registered as NCT06212752 by Merck Sharp & Dohme LLC, with 39 participants enrolled, started 2023-06-13 and due to reach its primary completion in 2024-11-06. Interventions recorded: Pembrolizumab Formulated with Berahyaluronidase Alfa, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel. Conditions listed: Metastatic Non-small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.

Setting

A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer

Phase

Phase 3

Sponsor

Merck Sharp & Dohme LLC

Registry

Started

2023-06-13

Reported

2025

Enrolled

39 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

39 enrolled

Objective Response Rate (ORR)primaryresponse endpoint

64.3 vs 18.2 out of 100 had their tumour shrink with Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy compared with Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy; 46.1 more per 100.
Roughly one extra person helped for every 2 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.

A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.
These results apply to the people the trial enrolled: A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer. People in a different situation may not see the same effect.
Only 39 people took part, so the numbers are less certain than in a large trial.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

39 enrolled.

Objective Response Rate (ORR)primary

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy64.3 of 100

n = 28

Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy18.2 of 100

n = 11

Download

95% CI 44.1 to 81.4; Figures from the ClinicalTrials.gov results section (first posted 2025-11-12), not from a publication · 95% CI 2.3 to 51.8

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Objective Response Rate (ORR)primary	Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy	28	64.3%	-	-	link
Objective Response Rate (ORR)primary	Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy	11	18.2%	-	-	link

Connected

Similar pages

cancers

Non-small-cell lung cancer Small-cell lung cancer

technologies

Immune checkpoint inhibitors

drugs

ApprovedCytotoxic chemotherapy (platinum)

ApprovedCytotoxic chemotherapy (platinum)

Cisplatin · Platinol (generic)

ApprovedRecombinant granulocyte colony-stimulating factor

Filgrastim (G-CSF) · Neupogen

ApprovedCytotoxic chemotherapy (taxane)

Paclitaxel / nab-paclitaxel · Taxol / Abraxane

ApprovedMonoclonal antibody (anti-PD-1)

Pembrolizumab · Keytruda / Keytruda Qlex (SC)

ApprovedCytotoxic (antifolate)

Pemetrexed · Alimta (and generics)

companies

Merck & Co. (MSD)