NCT06074588

Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

A Randomized, Open-label, Phase 3 Study of MK-2870 vs Chemotherapy (Docetaxel or Pemetrexed) in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 556 (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 chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
BIOLOGICAL	Sacituzumab tirumotecan	4 mg/kg of MK-sacituzumab tirumotecan by IV infusion
DRUG	Docetaxel	75 mg/m\^2 of docetaxel by IV Infusion
DRUG	Pemetrexed	500 mg/m\^2 of pemetrexed by IV infusion

Timeline

• Start date: 2023-11-12
• Primary completion: 2027-05-10
• Completion: 2030-03-11
• First posted: 2023-10-10
• Last updated: 2026-02-13

Locations

192 sites across 25 countries: United States, Australia, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Malaysia, Mexico, Philippines, Poland, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study