trialsTrialActive

Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participan

A phase 3 trial of Pembrolizumab, Paclitaxel / nab-paclitaxel, Carboplatin in non-small-cell lung cancer and small-cell lung cancer, run by Merck Sharp & Dohme LLC, active and no longer recruiting.

Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86) is a phase 3 interventional study registered as NCT04956692 by Merck Sharp & Dohme LLC, with 531 participants enrolled, started 2021-08-05 and due to reach its primary completion in 2023-04-04. Interventions recorded: Pembrolizumab SC, Pembrolizumab IV, Paclitaxel, Nab-Paclitaxel, Carboplatin. Conditions listed: Non-Small Cell Lung Cancer. Results were posted on ClinicalTrials.gov in 2024; the figures recorded here are the registry's, not a publication's.

Setting

A Randomized, Phase 3, Open-label Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab, Administered With Platinum Doublet Chemotherapy, in the First-Line Treatment of Participants With Metastatic Squamous or Nonsquamous Non-Small-Cell Lung Cancer

Phase

Phase 3

Sponsor

Merck Sharp & Dohme LLC

Registry

Started

2021-08-05

Reported

2024

Enrolled

531 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

531 enrolled

Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumabprimaryother endpoint

Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy: 471.3 hr*µg/ml; Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy: 455 hr*µg/ml.

The p-value (<0.0001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
These results apply to the people the trial enrolled: A Randomized, Phase 3, Open-label Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Versus Intravenous Pembrolizumab, Administered With Platinum Doublet Chemotherapy, in the First-Line Treatment of Participants With Metastatic Squamous or Nonsquamous Non-Small-Cell Lung Cancer. People in a different situation may not see the same effect.

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.

531 enrolled.

Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumabprimary

· p <0.0001

Download

95% CI 452.22 to 491.26; Figures from the ClinicalTrials.gov results section (first posted 2024-05-17), not from a publication · 95% CI 438.54 to 471.99

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Cycle 1 Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumabprimary	Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy	355	471.33 hr*µg/ml	-	<0.0001	link
	Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy	170	454.96 hr*µg/ml	-	<0.0001	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)

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)