NCT06784791

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Amivantamab Intravenous	Stage 1: Pre-operative amivantamab monotherapy Stage 2: Pre-operative amivantamab treatment plus chemotherapy (carboplatin/pemetrexed)
DRUG	Carboplatin/Pemetrexed	Stage 2: Pre-operative amivantamab plus chemotherapy (carboplatin/pemetrexed)

Timeline

• Start date: 2024-11-06
• Primary completion: 2027-07-31
• Completion: 2027-12-31
• First posted: 2025-01-20
• Last updated: 2025-08-29

Locations

4 sites across 3 countries: Belgium, Germany, Netherlands