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A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01)

NCT06731907 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-18

No results posted yet for this study

Summary

Researchers are investigating new treatments for untreated advanced non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and lung cancer that has spread beyond surgical removal. Standard treatments include immunotherapy, such as pembrolizumab, and chemotherapy. This study aims to determine the effectiveness of adding other treatments, including the human epidermal growth factor receptor 3-directed antibody-drug conjugate (HER3-DXd) patritumab deruxtecan, to pembrolizumab, with or without chemotherapy. The primary goals are to assess safety and efficacy of the treatments.

Conditions

Interventions

BIOLOGICAL

Pembrolizumab

Pembrolizumab 200mg IV Infusion.

DRUG

Carboplatin

Carboplatin IV infusion AUC5 or 6 mg/mL•min and not exceeding 900mg.

DRUG

Paclitaxel

Paclitaxel 200 mg/m\^2 IV infusion.

DRUG

Nab-paclitaxel

Nab-paclitaxel 100mg/m\^2 IV infusion.

DRUG

Pemetrexed

Pemetrexed 500mg/m\^2 IV infusion.

BIOLOGICAL

HER3-DXd

HER3-Dxd 5.6mg/kg IV infusion.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-30
Primary Completion
2032-03-12
Completion
2032-03-12
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT06731907 on ClinicalTrials.gov