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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).

Phase 2RecruitingUniversity Hospital, EssenNCT06784791Data as of May 2026

Treatment: Amivantamab Intravenous · Carboplatin/PemetrexedThe 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.

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Extracted 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

No prior treatment (treatment-naive required)
Max 0 prior lines

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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