Clinical Trial

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

Study acronym: AMIGO-1
Active, Not Recruiting Phase 2
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Record status
This record was last updated October 1, 2025 (before its estimated January 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2022-03-17; most recent amendment 2025-09-25.
Status change: Recruiting → Active, Not Recruiting 2025-02-11
Status change: Not Yet Recruiting → Recruiting 2023-06-01
Trial Details
NCT Number NCT05299125
Lead Sponsor Latin American Cooperative Oncology Group
Collaborators: Janssen, LP
Conditions Metastatic Non-small Cell Lung Cancers
Enrollment 54 participants
Start Date 2023-05-24
Primary Completion 2026-01-30 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-01