NCT06305754

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs). The primary hypotheses of this study are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS).

Detailed description

Participants will be randomized 1:1 into two arms: * Sacituzumab tirumotecan * Pemetrexed plus Carboplatin Participants will receive treatment until any of the criteria for discontinuation of study intervention are met.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
BIOLOGICAL	Sacituzumab tirumotecan	4 mg/kg via IV infusion
DRUG	Pemetrexed	500 mg/m\^2 via IV infusion
DRUG	Carboplatin	AUC 5 mg/mL\*min via IV infusion
DRUG	H1 Receptor Antagonist	Administered as rescue medication per approved product label
DRUG	H2 Receptor Antagonist	Administered as rescue medication per approved product label
DRUG	Acetaminophen (or equivalent)	Administered as rescue medication per approved product label
DRUG	Dexamethasone (or equivalent)	Administered as rescue medication per approved product label
DRUG	Steroid Mouthwash (dexamethasone or equivalent)	Administered as rescue medication per approved product label

Timeline

• Start date: 2024-06-11
• Primary completion: 2028-09-12
• Completion: 2030-06-14
• First posted: 2024-03-12
• Last updated: 2026-04-02

Locations

156 sites across 19 countries: United States, Argentina, Canada, China, Colombia, France, India, Italy, Japan, Malaysia, Mexico, Poland, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Vietnam

Regulatory

• FDA-regulated drug study