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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |