drugset / Trial / 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)

NCT06074588

Phase 3 Active not recruiting 556 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

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 hypothesis is that sacituzumab tirumotecan is superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

Timeline

Start
2023-11-12
Primary completion
2027-05-10
Completion
2030-03-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Comparator Pemetrexed Small molecule 500 mg/m2 Intravenous
Subject Sacituzumab Tirumotecan Other / unclassified 4 mg/kg Intravenous