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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07630077
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are willing to take part voluntarily and have signed a consent form showing they understand and agree to the study.
- People aged between 18 and 75 years old at the time of signing the consent form.
- People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or able to carry out light work (confirm with trial site).
- People with an expected survival of more than 3 months.
- People diagnosed with non-small cell lung cancer (NSCLC) that is locally advanced, has spread to other parts of the body, or has come back after previous treatment, and where surgery and combined radiation and chemotherapy are not suitable options — with the cancer type confirmed by a lab test on tissue or cell samples. (Note: If the tumour contains any small cell component, the person would not meet this criterion.)
- People in Group 1 who have already received one round of treatment that stopped working, and whose cancer shows a specific protein marker called HER2 (either amplified or overexpressed at 2+ or 3+ level); OR people in Group 2 who have not yet received any treatment for their cancer, whose cancer shows HER2 amplification or overexpression (2+ or 3+), and whose cancer also tests positive for a marker called PD-L1 at 1% or higher.
- People who have at least one measurable area of cancer that can be tracked using standard imaging measurements (known as RECIST 1.1 criteria); areas previously treated with radiation cannot be counted unless the cancer has clearly grown back there.
- People whose blood and organ function results meet all of the following levels: neutrophil count at least 1,500 per microlitre; platelet count above 90,000 per microlitre; haemoglobin at least 9 g/dL (blood transfusion is allowed to reach this level); creatinine no more than 1.5 times the upper limit of normal; total bilirubin no more than 1.5 mg/dL or 26 μmol/L; liver enzyme levels (AST and ALT) within acceptable ranges depending on whether liver spread is present; and albumin at least 2.5 g/dL.
- Women of reproductive age and their male partners must agree to use effective contraception (hormonal methods, barrier methods, or abstinence) before joining, throughout the study, and for 90 days after finishing. Women who become pregnant or suspect they may be pregnant during the study must inform their doctor immediately. (Reproductive age applies to women who have not had a hysterectomy or both ovaries removed, and who have had a menstrual period at any point in the past 12 months.)
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have previously been treated with any anti-HER2 therapy, including antibodies, targeted small molecule drugs (TKIs), or antibody-drug combinations (ADCs).
- People who have a history of interstitial lung disease, pneumonitis related to radiation or immune treatments, active non-infectious lung inflammation seen on scans, active tuberculosis, dust-related lung disease, certain grades of other pneumonia, or severely reduced lung function confirmed by breathing tests.
- People who have had a blood clot event in an artery or deep vein within the 6 months before treatment, such as a stroke, mini-stroke, brain bleed, deep vein thrombosis, or pulmonary embolism.
- People with significant heart problems, including moderate-to-severe heart muscle damage or heart attack, certain abnormal heart rhythms (including specific measurements of the heart's electrical activity beyond set thresholds), moderate-to-severe heart failure, a pumping function of the heart (LVEF) below 50%, chest pain requiring medication, or significant heart valve disease.
- People with active autoimmune diseases or a history of autoimmune conditions such as Crohn's disease, ulcerative colitis, autoimmune hepatitis, or similar conditions — with some exceptions for well-controlled conditions such as type 1 diabetes managed with insulin, an underactive thyroid managed with hormone replacement, skin conditions not needing systemic treatment, or conditions considered cured and unlikely to return.
- People who need ongoing treatment with immune-suppressing medications (taken by mouth, injection, or applied locally for an immune-suppressing purpose) and who would still need to use them within 2 weeks before being assigned to a treatment group.
- People who have fluid build-up in the chest, abdomen, or around the heart that requires repeated draining to relieve symptoms, or who have had fluid drained for treatment purposes within 2 weeks before starting the trial.
- People with brain or central nervous system (CNS) spread of cancer that is causing symptoms or is getting worse, or who have cancer spreading through the fluid around the brain and spine; people with a history of brain metastases may be considered if their condition is clinically stable (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 July 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression free survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.