OncoMatch/Clinical Trials/NCT06784791
Preoperative Amivantamab or Amivantamab and Carboplatin/Pemetrexed Treatment in Patients With Resectable Non-small-cell Lung Cancer Harboring Oncogenic EGFR Mutations (NEOpredict-EGFR)
Is NCT06784791 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Amivantamab Intravenous and Carboplatin/Pemetrexed for lung cancer (nsclc).
Treatment: Amivantamab Intravenous · Carboplatin/Pemetrexed — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR L858R
Confirmation of an oncogenic EGFR mutation (EGFR p.L858R, EGFR exon 19 in-frame deletion, EGFR exon 20 in-frame insertions, EGFR p.S768I, EGFR p.L861Q, EGFR p.G719x - additional EGFR mutations with clinically validated oncogenicity and susceptibility to amivantamab may be eligible...)
Required: EGFR exon 19 in-frame deletion
Confirmation of an oncogenic EGFR mutation (EGFR p.L858R, EGFR exon 19 in-frame deletion, EGFR exon 20 in-frame insertions, EGFR p.S768I, EGFR p.L861Q, EGFR p.G719x - additional EGFR mutations with clinically validated oncogenicity and susceptibility to amivantamab may be eligible...)
Required: EGFR exon 20 in-frame insertions
Confirmation of an oncogenic EGFR mutation (EGFR p.L858R, EGFR exon 19 in-frame deletion, EGFR exon 20 in-frame insertions, EGFR p.S768I, EGFR p.L861Q, EGFR p.G719x - additional EGFR mutations with clinically validated oncogenicity and susceptibility to amivantamab may be eligible...)
Required: EGFR S768I
Confirmation of an oncogenic EGFR mutation (EGFR p.L858R, EGFR exon 19 in-frame deletion, EGFR exon 20 in-frame insertions, EGFR p.S768I, EGFR p.L861Q, EGFR p.G719x - additional EGFR mutations with clinically validated oncogenicity and susceptibility to amivantamab may be eligible...)
Required: EGFR L861Q
Confirmation of an oncogenic EGFR mutation (EGFR p.L858R, EGFR exon 19 in-frame deletion, EGFR exon 20 in-frame insertions, EGFR p.S768I, EGFR p.L861Q, EGFR p.G719x - additional EGFR mutations with clinically validated oncogenicity and susceptibility to amivantamab may be eligible...)
Required: EGFR G719X
Confirmation of an oncogenic EGFR mutation (EGFR p.L858R, EGFR exon 19 in-frame deletion, EGFR exon 20 in-frame insertions, EGFR p.S768I, EGFR p.L861Q, EGFR p.G719x - additional EGFR mutations with clinically validated oncogenicity and susceptibility to amivantamab may be eligible...)
Allowed: EGFR additional EGFR mutations with clinically validated oncogenicity and susceptibility to amivantamab
additional EGFR mutations with clinically validated oncogenicity and susceptibility to amivantamab may be eligible following discussion and approval by the coordinating investigator
Disease stage
Required: Stage IB, II, SELECTED IIIA (T3 N1, T4 WITH SATELLITE NODULE IN THE SAME LUNG N0/N1, SELECTED T1A-T2B N2 CASES) (UICC 8th edition)
Excluded: Stage MULTILEVEL N2, DISTANT METASTASES
Clinical stages I B, II or selected stage III A (T3 N1, T4 with satellite nodule in the same lung N0/N1, selected T1a-T2b N2 cases considered suitable for primary surgical approach by the multidisciplinary tumor board) according to UICC 8th edition
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: EGFR tyrosine kinase inhibitor
Prior treatment with amivantamab or any EGFR tyrosine kinase inhibitor
Cannot have received: amivantamab (amivantamab)
Prior treatment with amivantamab
Cannot have received: any concurrent preoperative antineoplastic treatment including irradiation
Any other concurrent preoperative antineoplastic treatment including irradiation
Lab requirements
Blood counts
Leukocytes ≥ 2,000/mm³, platelets ≥ 100,000/mm³, ANC ≥ 1,500/μL, hemoglobin ≥ 9 g/dL (stage 1) or 10 g/dL (stage 2)
Kidney function
Serum creatinine ≤ 1.5 x ULN and creatinine clearance >45 mL/min (Cockcroft-Gault)
Liver function
Bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3.0 x ULN, alkaline phosphatase ≤ 6 x ULN. Subjects with Gilbert's syndrome can be enrolled if conjugated bilirubin is within normal limits
Cardiac function
LVEF ≥ 50% by echocardiography or MUGA within 6 months before first administration of study drug
Adequate hematological, hepatic and renal function parameters... Sufficient cardiac left ventricular defined as LVEF ≥ 50% documented either by echocardiography or MUGA
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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