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

NCT06788912 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-31

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2032-02-06
Completion
2032-02-06
FDA Drug
Yes

Countries

  • United States
  • Chile
  • Greece
  • Hungary
  • Italy
  • Poland
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06788912 on ClinicalTrials.gov