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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508308-40-00

Acronym

MK-3475-A86

Enrollment

215

Registered

2024-03-25

Start date

2021-07-30

Completion date

Unknown

Last updated

2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic (stage IV) squamous or nonsquamous non-small cell lung cancer (NSCLC).

Brief summary

Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab at Cycle 1, Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab

Detailed description

Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR), Observed Ctrough of Pembrolizumab at the End of Cycle 1, Maximum Concentration (Cmax) of Pembrolizumab at Cycle 1, AUC 0-3wks of Pembrolizumab at Cycle 6, Cmax of Pembrolizumab at Cycle 6, Observed Ctrough of Pembrolizumab at the End of Cycle 6, Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an AE, Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR, Overall Survival (OS), Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGpembrolizumab

DRUGCARBOPLATIN

DRUGPACLITAXEL ALBUMIN-BOUND

DRUGPACLITAXEL

DRUGCISPLATIN

DRUGPEMETREXED

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Area Under The Curve From 0-3 Weeks (AUC 0-3wks) of Pembrolizumab at Cycle 1, Cycle 6 Model-Based Minimal Concentration (Ctrough) of Pembrolizumab	—

Secondary

Measure	Time frame
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR), Observed Ctrough of Pembrolizumab at the End of Cycle 1, Maximum Concentration (Cmax) of Pembrolizumab at Cycle 1, AUC 0-3wks of Pembrolizumab at Cycle 6, Cmax of Pembrolizumab at Cycle 6, Observed Ctrough of Pembrolizumab at the End of Cycle 6, Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an AE, Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR, Overall Survival (OS), Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR, Anti-Drug Antibodies (ADAs) Incidence After Administration of Pembrolizumab	—

Measure

Time frame

—

Countries

France, Hungary, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026