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

Sponsor
University Hospital, Essen
Study ID
NCT06784791
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 6, 2024
Status verified
Aug 2025
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pre-operative amivantamab monotherapy
    Patients in stage 1 will receive 1 cycle (28 days) of pre-operative amivantamab monotherapy, splitted on 5 treatment days. Dosing will be weight-adapted.
  • Experimental: Amivantamab + chemotherapy
    Patients in stage 2 will receive 1 cycle (28 days) of pre-operative amivantamab monotherapy, splitted on 5 treatment days (dosing will be weight-adapted) plus additional chemotherapy (carboplatin/pemetrexed) on day 1.

Primary Outcome Measure

Feasibility of one cycle of preoperative amivantamab therapy [ Time Frame: 28 days pre-operative treatment ]

Central Contacts

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