drugset / Trial / NCT05299125

Amivantamab, Lazertinib, and Pemetrexed for First-line Treatment of Recurrent/Metastatic Non-small Cell Lung Cancers With Epidermal Growth Factor Receptor Mutations

NCT05299125

Phase 2 Active not recruiting 54 enrolled Latin American Cooperative Oncology Group Janssen, LP · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a phase II, single-arm, multicenter trial, conducted through Latin American Coorperative Oncology Group (LACOG). Treatment-naïve patients with recurrent/metastatic NSCLCs harboring EGFR exon 19 deletions or exon 21 L858R point mutations will be enrolled. At baseline, an archival or (optional) new tissue sample will be obtained for biomarker evaluation, as well as liquid biopsies. Treatment will continue until disease progression or unacceptable toxicity.

Timeline

Start
2023-05-24
Primary completion
2026-01-30
Completion
2027-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Amivantamab Monoclonal antibody 1750 mg Intravenous
Subject Amivantamab Monoclonal antibody 2100 mg Intravenous
Subject Lazertinib Small molecule 240 mg Oral
Subject Pemetrexed Small molecule 500 mg/m2 Intravenous