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New treatment option for Non-Small Cell Lung Cancer
Official title Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.
ClinicalTrials.gov ID: NCT07192068
What this study is testing
What is Zanidatamab?
Zanidatamab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed endometrial, colorectal, head \& neck, non-small cell lung cancer (NSCLC), or sarcoma
- Patient with progressive, unresectable and/or advanced or metastatic disease harboring a locally performed, centrally reviewed HER2-overexpressing...
- Age ≥ 18 years at inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Patient who progressed at least after 1 line of therapy, for whom there is no other standard therapeutic option available
You likely can't join if
- Patient, in the judgment of the investigator, who should be included in another recruiting study assessing an anti-HER2 therapy (including...
- Patient who received prior treatment with HER2-directed therapy unless marketed for the study cohort indication.
- Other primary malignancies within 3 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or...
- Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement not related to lung metastases (e.g. rheumatoid arthritis...
- Prior pneumonectomy
- Patient with any condition or any evidence of severe or uncontrolled systemic diseases (e.g. active bleeding diatheses, active infection, or...
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed endometrial, colorectal, head \& neck, non-small cell lung cancer (NSCLC), or sarcoma
- Patient with progressive, unresectable and/or advanced or metastatic disease harboring a locally performed, centrally reviewed HER2-overexpressing (IHC 3+ exclusively) for endometrial, colorectal, head \& neck cancers...
- Age ≥ 18 years at inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Patient who progressed at least after 1 line of therapy, for whom there is no other standard therapeutic option available
- Patient with a HER2 alteration covered by a standard marketed indication for any HER2 targeting therapy should be included after standard anti-HER2 strategy has been exhausted.
- Estimated life expectancy \>3 months
- Measurable disease according to RECIST1.1, whatever the disease location. Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable if...
- 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 × the upper limit of normal (ULN) range (total bilirubin ≤3.0 ULN when the patient has documented Gilbert syndrome or liver metastasis), and aspartate aminotransferase...
- Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 14 days before inclusion
- Normal prothrombin time (PT) \>70% and partial thromboplastin time (PTT), except for patient who uses anticoagulants
- Adequate renal function: estimated serum creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula
- Man, and woman of childbearing potential must agree to use highly effective contraception for the duration of trial participation and as required after completing study treatment (refer to Table 6 in the protocol). Man...
- Woman of childbearing potential must have a negative serum pregnancy test performed within 3 days before the date of treatment initiation
- Availability of a suitable archived FFPE sample of primary or metastatic tumor tissue (archived FFPE is \<2 years old (desirable), maximum 5 years (accepted), buffered formalin fixed only. Fine-needle aspiration...
- Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, specimen sampling for research, and other study procedures
- Affiliated to a social security system
- Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from...
What rules you out
- Patient, in the judgment of the investigator, who should be included in another recruiting study assessing an anti-HER2 therapy (including zanidatamab)
- Patient who received prior treatment with HER2-directed therapy unless marketed for the study cohort indication.
- Other primary malignancies within 3 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivor, who has undergone...
- Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement not related to lung metastases (e.g. rheumatoid arthritis, Sjögren's syndrome, sarcoidosis)
- Prior pneumonectomy
- Patient with any condition or any evidence of severe or uncontrolled systemic diseases (e.g. active bleeding diatheses, active infection, or psychiatric illness) which in the investigator's opinion makes it undesirable...
- History of myocardial infarction or unstable angina within 6 months prior to enrolment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease, such as ventricular arrhythmia...
- Evidence of spinal cord compression or brain metastases, defined as being clinically active and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Patient with...
- Patient with evidence of any leptomeningeal disease. If leptomeningeal disease has been reported radiographically on baseline magnetic resonance imaging (MRI), but is not suspected clinically by the investigator, the...
- Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease
- Patient with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤1 or baseline, as defined by National Cancer Institute Common Terminology...
- Patient receiving chronic systemic corticosteroids dosed at \>10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy within 2 weeks of first zanidatamab dosing unless...
- Treatment with anthracyclines within 90 days before first dose of zanidatamab and/or total lifetime load exceeding 360 mg/m2 doxorubicin or equivalent
- A history of life-threatening hypersensitivity to monoclonal antibodies or recombinant proteins
- Woman who is pregnant or breast-feeding
- Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable
- Patient unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
- Individual deprived of liberty or placed under protective custody or guardianship.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Marseille, France
- Vandœuvre-lès-Nancy, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Marseille, France; Vandœuvre-lès-Nancy, France; Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.