Actively Recruiting
Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harboring Oncogenic EGFR Mutations (NEOpredict-EGFR)
Led by University Hospital, Essen · Updated on 2025-08-29
20
Participants Needed
4
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harboring Oncogenic EGFR Mutations (NEOpredict-EGFR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with non-small-cell lung cancer (NSCLC) eligible for surgical removal, clinical stages I B, II, or selected III A
- Confirmed oncogenic EGFR mutation by validated testing before treatment
- Male or female aged 18 years or older
- Negative pregnancy test if of childbearing potential and agreement to use contraception during and for 6 months after the study
- ECOG performance status 0 or 1 (able to carry out daily activities)
- No extensive mediastinal lymph node metastases as determined by imaging and biopsy
- No distant metastases as confirmed by imaging studies
- Measurable target tumor before starting study therapy
- Adequate lung function to undergo surgery (FEV1 and DLCO above 30%)
- Adequate blood counts and organ function (liver, kidney, blood clotting)
- Sufficient heart function (left ventricular ejection fraction at least 50%) within 6 months prior to treatment
- Willing and able to provide informed consent and comply with study and surgical procedures
You will not qualify if you...
- Lung cancer stage or type outside those defined in inclusion criteria
- No detectable oncogenic EGFR mutation in pretreatment biopsy
- Active or past interstitial lung disease or pneumonitis
- Need for continuous systemic immunosuppressive therapy or high-dose corticosteroids
- History of organ or stem cell transplantation
- Lung function below thresholds indicating inability to undergo surgery
- Recent or uncontrolled significant cardiovascular disease (heart attack, angina, arrhythmias, uncontrolled hypertension, blood clots)
- Need for daily supplemental oxygen due to heart or lung disease
- Active neurological disease
- Active cancer or cancer within past 3 years except certain treated or low-risk cancers
- Known HIV infection
- Positive hepatitis B or C tests without adequate control
- Uncontrolled diabetes
- Active infection requiring treatment
- Psychiatric or social conditions limiting compliance
- Clinically unstable eye conditions
- Other diseases or conditions that increase risk or interfere with study drugs
- Recent live vaccination within 30 days
- Recent serious wounds or surgery within 28 days except minor procedures
- Use of other preoperative cancer treatments
- Pregnant or breastfeeding women
- Poor heart function (LVEF below 50%)
- History of severe infusion reactions to antibody or immune therapies
- Prior treatment with amivantamab or EGFR tyrosine kinase inhibitors
- Participation in other interventional studies within 3 months
- Other investigator-determined reasons for exclusion
- Contraindications against amivantamab, carboplatin, or pemetrexed (stage specific)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Jessa Ziekenhuis, Department of Pneumology
Hasselt, Belgium, 3500
Actively Recruiting
2
Thoraxklinik Heidelberg gGmbH, Studienzentrum Thoraxonkologie
Heidelberg, Baden-Wurttemberg, Germany, 69126
Actively Recruiting
3
West German Cancer Center, Department of Medical Oncology, University Hospital Essen
Essen, Germany, Germany, 45147
Actively Recruiting
4
Erasmus Universitair Medisch Centrum Rotterdam Department of Pulmonary Medicine
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
Research Team
M
Martin Schuler, Prof. Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here