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)
Summary
The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state. Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.
Timeline
- Start
- 2021-08-05
- Primary completion
- 2023-04-04
- Completion
- 2026-10-14
Outcome
Met primary endpoint
registry analysis (non-inferiority test); Arm A: Pembrolizumab SC + Platinum Doublet Chemotherapy vs Arm B: Pembrolizumab IV + Platinum Doublet Chemotherapy; p <0.0001; NCT04956692 ↗
registry Geometric Mean Ratio (GMR) 1.85 (94% CI 1.69 to 2.03); t-test, 1 sided; note: The one-sided p-value non-inferiority boundary is 0.03 NCT04956692 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | — | Subcutaneous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Cisplatin | Other / unclassified | — | Intravenous |
| Background | Nab-paclitaxel | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |
| Background | Pemetrexed | Small molecule | — | Intravenous |