OncoMatch/Clinical Trials/NCT07192068
Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.
Is NCT07192068 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Zanidatamab for non-small cell lung cancer.
Treatment: Zanidatamab — Alterations in the HER2 gene are involved in the development of cancer. These abnormalities are found at highly variable rates (from approximately 2% to 60%) in cancers of the lung, breast, stomach, bile ducts, salivary glands, colon, endometrium, uterus, bladder, bones, blood, etc. Zanidatamab is an anti-cancer drug that acts on cells with alterations in the HER2 gene. It is used in Europe to treat people with bile duct cancer. However, in various clinical trials, zanidatamab has shown promising activity in a few patients with different cancers that have a HER2 gene alteration. This treatment could therefore be effective in several types of cancer once this gene alteration is detected. The primary objective is to evaluate the efficacy of zanidatamab in patients with cancer in one of the following locations: endometrium, colorectal, head and neck, sarcoma or lung cancer. Efficacy will be measured by the number of patients in whom a reduction in tumour size was observed. All patients included in the study will receive zanidatamab by intravenous infusion every 3 weeks. Treatment will continue as long as there is a benefit (stabilisation or regression of the disease). During treatment, participants will visit the hospital regularly for medical consultations to: * assess and treat potential adverse effects of zanidatamab. A dose reduction may be applied to improve tolerance. * monitor disease progression using scans and/or MRI, performed every 6 weeks for the first 18 months of treatment and then every 12 weeks. After treatment is stopped (due to intolerance or disease progression), patients will be monitored according to hospital practices until the end of the trial, i.e. for 1 to 4 years, depending on when they were included in the clinical trial.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Sarcoma
Colorectal Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ exclusively) (IHC 3+ exclusively)
HER2-overexpressing (IHC 3+ exclusively) for endometrial, colorectal, head & neck cancers, or sarcoma
Required: HER2 (ERBB2) activating mutation
HER2 activating mutation for NSCLC
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: HER2-directed therapy
Exception: unless marketed for the study cohort indication
Patient who received prior treatment with HER2-directed therapy unless marketed for the study cohort indication.
Cannot have received: anthracycline (doxorubicin)
Exception: total lifetime load exceeding 360 mg/m2 doxorubicin or equivalent
Treatment with anthracyclines within 90 days before first dose of zanidatamab and/or total lifetime load exceeding 360 mg/m2 doxorubicin or equivalent
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L, platelet count ≥75 × 10⁹/L, haemoglobin ≥9 g/dL (transfusion allowed with 2-week washout)
Kidney function
estimated serum creatinine clearance ≥ 30 mL/min (Cockcroft-Gault)
Liver function
total bilirubin level ≤1.5 × ULN (≤3.0 ULN when Gilbert syndrome or liver metastasis), AST and ALT ≤2.5 × ULN (≤5 ULN when tumor liver involvement)
Cardiac function
LVEF ≥ 50% at baseline by ECHO or MUGA within 14 days before inclusion
Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5 × 10⁹/L, platelet count ≥75 × 10⁹/L, and haemoglobin ≥9 g/dL. Transfusion is allowed with a 2-week washout period before treatment initiation; Adequate liver function: total bilirubin level ≤1.5 × ULN (≤3.0 ULN when the patient has documented Gilbert syndrome or liver metastasis), and AST and ALT ≤2.5 × ULN (≤5 ULN when documented tumor liver involvement); Adequate cardiac function: LVEF ≥ 50% at baseline as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 14 days before inclusion; Adequate renal function: estimated serum creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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