NCT06731907

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)

KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-30
• Primary completion: 2032-03-12
• Completion: 2032-03-12
• First posted: 2024-12-13
• Last updated: 2026-02-18

Locations

41 sites across 11 countries: United States, Chile, Greece, Hungary, Israel, Italy, Poland, Spain, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study