drugset / Trial / NCT06784791

Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harboring Oncogenic EGFR Mutations (NEOpredict-EGFR)

NCT06784791

Phase 2 Recruiting 20 enrolled University Hospital, Essen
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary objective of this study is to determine the feasibility of four weeks of preoperative antibody therapy with amivantamab. Amivantamab will be administered as monotherapy (stage 1), and combined with carboplatin/pemetrexed chemotherapy (stage 2). Study treatment is followed by standard of care surgery, and (if clinically indicated) standard of care adjuvant therapy (chemotherapy, radiotherapy, EGFR tyrosine kinase inhibitor therapy) in patients with early stage or locally advanced non-small-cell lung cancer harboring oncogenic EGFR mutations who are eligible for curative resection.

Timeline

Start
2024-11-06
Primary completion
2027-07-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Amivantamab Monoclonal antibody Intravenous
Subject Carboplatin Small molecule
Subject Pemetrexed Small molecule