NCT06788912

Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)

KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.

Conditions

• Lung Neoplasm Malignant

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab (neoadjuvant)	Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles
DRUG	Cisplatin	Cisplatin 75 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
DRUG	Gemcitabine	In squamous tumors Gemcitabine 1000 mg/m\^2 by IV infusion on day 1 and day 8 of each 21-day cycle for 4 cycles.
DRUG	Pemetrexed	In nonsquamous tumors Pemetrexed 500 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
DRUG	Sacituzumab tirumotecan	Sacituzumab tirumotecan 4 mg/kg by IV infusion on day 1 of each 14-day cycle for up to 6 cycles
DRUG	H1 receptor antagonist	Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
DRUG	H2 receptor antagonist	Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
DRUG	Acetaminophen (or equivalent)	Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
DRUG	Dexamethasone (or equivalent)	Administered as rescue medication 8 -10 mg before Sacituzumab tirumotecan infusion per approved product label
DRUG	Carboplatin	AUC 5 mg/mL min or AUC 6 mg/mL min by IV infusion on day 1 of each 21-day cycle for 4 cycles
BIOLOGICAL	Pembrolizumab (adjuvant)	After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles
DRUG	Paclitaxel	Paclitaxel 175 or 200 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles.
DRUG	Steroid mouthwash (dexamethasone or equivalent)	Administered orally as rescue medication 2-5 mL 4 times daily

Timeline

• Start date: 2025-03-20
• Primary completion: 2032-02-06
• Completion: 2032-02-06
• First posted: 2025-01-23
• Last updated: 2026-03-31

Locations

34 sites across 9 countries: United States, Chile, Greece, Hungary, Italy, Poland, Spain, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study