Non-Small Cell Lung CancerPhase 2AcSé HER2NCT07192068
Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.
A Phase 2 study testing Zanidatamab in people with Non-Small Cell Lung Cancer and Sarcoma, run by UNICANCER at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Sarcoma, Head &Amp; Neck Cancer
- What is being tested?
- Zanidatamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 4 sitesFrance
- Study dates
- 30 Oct 2025to 24 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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, or sarcoma or a HER2 activating mutation for NSCLC, determined on tissue (see Section 7.1.2 of the protocol)
- 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.
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- 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 progression has been clearly demonstrated in the lesion
- 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 (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 ULN when documented tumor liver involvement)
- 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 must also agree to not donate sperm and women must agree to not donate oocytes during the specified period
- 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 (cytology samples) and biopsies from sites of bone metastases are not acceptable) or patient accepts an optional biopsy under study
- 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 the investigator or the sponsor, can confirm in signing the patient's consent.
Who cannot join
- 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 potentially curative therapy for a prior malignancy, has no evidence of that disease for 4 years or more and is deemed at negligible risk for recurrence, is eligible for the trial
- 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 for the patient to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required for eligibility
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- 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 requiring therapy, uncontrolled hypertension, or any history of symptomatic congestive heart failure
- 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 clinically inactive or treated brain metastases who are asymptomatic (i.e. without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the study. Patient must have a stable neurologic status and no evidence of radiographic progression for at least 2 weeks prior to first zanidatamab dosing
- 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 subject must be free of neurological symptoms.
- 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 Criteria for Adverse Events (NCI-CTCAE) version 5.0. Patient with chronic Grade 2 toxicities may be enrolled at the discretion of the investigator after consultation and approval by the coordinating investigator.
- 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 otherwise approved by the coordinating investigator. Patient who requires use of bronchodilators, inhaled or topical or ocular steroids, or local steroid injections may be included in the study
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marta JIMENEZ contact
France4 sites, 2 recruiting
- Active, not recruiting
Institut de Cancérologie de l'Ouest
Angers
- Recruiting
Chu Timone
Marseille
Pascale TOMASINI, pascale.tomasini@ap-hm.fr
Albane TESTOT-FERRY, Albane.TESTOT-FERRY@ap-hm.fr
- Active, not recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
- Recruiting
Gustave Roussy
Villejuif
Barbara PISTILLI, Dr, +33 (0)1 42 11 61 62, barbara.pistilli@gustaveroussy.fr
About this study
Official title: Widening Treatment Options Among Adult Patients With HER2-overexpressing or Mutant Solid Cancers.
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.
Read more
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.
- Conditions
- Non-Small Cell Lung Cancer, Sarcoma, Head &Amp; Neck Cancer, Colorectal Carcinoma, Endometrial
- Being tested
- Zanidatamab
- Keywords
- zanidatamab, HER2 mutant, HER2-IHC3+
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Sarcoma, Head and Neck Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanidatamabDrug
Single arm study where the experimental regimen used for all patients will be zanidatamab, administered intravenously every 3 weeks :
- Patients <70 kg: 1800 mg IV Q3W on Day 1 of each 21-day cycle
- Patients ≥70 kg: 2400 mg IV Q3W on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| zanidatamab | Experimental | Single arm study where the experimental regimen used for all patients will be zanidatamab, administered intravenously every 3 weeks :
* Patients <70 kg: 1800 mg IV Q3W on Day 1 of each 21-day cycle
* Patients ≥70 kg: 2400 mg IV Q3W on Day 1 of each 21-day cycle. Receives: Drug: Zanidatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (ORR) by investigator
Confirmed Objective Response Rate (ORR) for each cohort, based on best overall response, defined as the percentage of patients with a complete response (CR) or partial response (PR) during treatment or follow-up, assessed according to RECIST1.1, by investigator assessment and confirmed by a follow-up scan at ≥ 4 weeks from first response assessment.
Measured: From Baseline to disease progression (up to 28 months)
Secondary outcomes (6)
Confirmed ORR by the BICR
Confirmed ORR for each cohort, based on best overall response as adjudicated by the BICR, defined as the percentage of patients with a CR or PR during treatment or follow-up, assessed according to RECIST1.1 and confirmed by a follow-up scan at ≥ 4 weeks from first response assessment
Measured: From baseline to the progression (up to 28 months)
Duration of Response (DoR)
Duration of Response (DoR) for each cohort will be evaluated in patients with either a CR or PR. DoR is defined as the time from the first assessment of a confirmed CR or PR until the date of the first occurrence of progressive disease (PD) according to RECIST1.1 or death from any cause (if death occurs within predefined period), whichever occurs first. At the time of analysis, a patient alive and without disease progression will be censored at the date of the last valid tumor assessment. DoR will be provided as assessed by investigators and as adjudicated by the BICR.
Measured: From baseline to the progression (up to 28 months)
Progression Free Survival (PFS)
Progression Free Survival (PFS) for each cohort is defined as the time from study registration until disease progression (per RECIST1.1) or death from any cause, whichever occurs first. At the time of analysis, a patient alive and without disease progression will be censored at the date of the last valid tumor assessment. PFS will be provided as assessed by investigators and as adjudicated by the BICR.
Measured: From baseline to disease progression or death (up to 28 months)
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) for each cohort is defined as the percentage of patients with a CR or PR or stable disease (SD) for more than 16 weeks from inclusion assessed according to RECIST1.1. CBR will be provided as assessed by investigators and as adjudicated by the BICR.
Measured: From baseline to the progression (up to 28 months)
Overall Survival (OS)
Overall Survival (OS) for each cohort is defined as the time from study registration until death from any cause. Patients who are alive at last follow-up will be censored at this date.
Measured: From baseline to death (up to 52 months)
Incidence of treatment-Emergent Adverse Events [Safety and Tolerability of zanidatamab]
The safety will be evaluated according to the incidence of adverse events (AEs) graded by NCI-CTCAE v5.0, per cohort and overall.
Measured: From baseline to the end of treatment (up to 28 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start30 Oct 2025
- Primary completion13 Mar 2028 (estimated)
- Study completion24 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Jazz Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Barbara PISTILLI, Dr, Principal investigator, Gustave Roussy, VILLEJUIF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192068
- Sponsor's protocol ID
- UC-GMP-2505
- Other IDs
- 2025-522169-31-00, 2025
- Acronym
- AcSé HER2
- Status last verified
- Dec 2025
- First submitted
- 21 Jun 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Widening Treatment Options Among Adult Patients With HER2-overexpressing or Mutant Solid Cancers.
- ClinicalTrials.gov ID
- NCT07192068
- Acronym / sponsor ID
- AcSé HER2 / UC-GMP-2505
- Conditions
- Non-Small Cell Lung Cancer, Sarcoma, Head &Amp; Neck Cancer, Colorectal Carcinoma, Endometrial
- Keywords
- zanidatamab, HER2 mutant, HER2-IHC3+
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Jazz Pharmaceuticals
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 13 Mar 2028 (estimated)
- Study completion
- 24 Jun 2030 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zanidatamab | Experimental | Drug: ZanidatamabSingle arm study where the experimental regimen used for all patients will be zanidatamab, administered intravenously every 3 weeks : * Patients <70 kg: 1800 mg IV Q3W on Day 1 of each 21-day cycle * Patients ≥70 kg: 2400 mg IV Q3W on Day 1 of each 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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, or sarcoma or a HER2 activating mutation for NSCLC, determined on tissue (see Section 7.1.2 of the protocol)
- 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
Key exclusion criteria (18 listed)
- 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 potentially curative therapy for a prior malignancy, has no evidence of that disease for 4 years or more and is deemed at negligible risk for recurrence, is eligible for the trial
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanidatamabSingle arm study where the experimental regimen used for all patients will be zanidatamab, administered intravenously every 3 weeks : * Patients <70 kg: 1800 mg IV Q3W on Day 1 of each 21-day cycle * Patients ≥70 kg: 2400 mg IV Q3W on Day 1 of each 21-day cycle. | Drug | zanidatamab |
Primary outcome
Confirmed Objective Response Rate (ORR) by investigator
Time frame: From Baseline to disease progression (up to 28 months)
Confirmed Objective Response Rate (ORR) for each cohort, based on best overall response, defined as the percentage of patients with a complete response (CR) or partial response (PR) during treatment or follow-up, assessed according to RECIST1.1, by investigator assessment and confirmed by a follow-up scan at ≥ 4 weeks from first response assessment.
6 secondary outcomes
Confirmed ORR by the BICR
Time frame: From baseline to the progression (up to 28 months)
Duration of Response (DoR)
Time frame: From baseline to the progression (up to 28 months)
Progression Free Survival (PFS)
Time frame: From baseline to disease progression or death (up to 28 months)
Clinical Benefit Rate (CBR)
Time frame: From baseline to the progression (up to 28 months)
Overall Survival (OS)
Time frame: From baseline to death (up to 52 months)
Incidence of treatment-Emergent Adverse Events [Safety and Tolerability of zanidatamab]
Time frame: From baseline to the end of treatment (up to 28 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No. Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta JIMENEZ contact
Barbara PISTILLI, Dr principal investigator
Gustave Roussy, VILLEJUIF
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanidatamab in people with Non-Small Cell Lung Cancer and Sarcoma, run by UNICANCER at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline MAHIER AIT OUKHATAR (+33 (0)6 17 51 34 29, c-mahier@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed Objective Response Rate (ORR) by investigator (time frame: From Baseline to disease progression (up to 28 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.