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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT05859217
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
- The person joining (or their legal representative) must be able to understand the study and be willing to sign a written consent form.
- Adults aged 18 years or older of any sex.
- People who are largely able to carry out daily activities with little or no restriction (confirm with trial site for exact fitness level required).
- People who have been diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) confirmed by laboratory testing, where a specific protein marker on their cancer cells (PD-L1) is found in less than 1% of cells using a particular laboratory test.
- People who have at least one measurable area of cancer that can be tracked over time using standard imaging measurements.
- People whose cancer does not have specific targetable genetic changes (such as in EGFR, ALK, or BRAF genes) and who have not yet received any systemic (whole-body) cancer treatment — though prior localised radiation therapy given more than 4 weeks earlier is allowed.
- People whose cancer does have specific targetable genetic changes (such as in EGFR, ALK, or BRAF genes) and who have already tried and had at least one FDA-approved targeted therapy fail, without having received other types of systemic cancer treatment such as chemotherapy or immunotherapy.
- A tumour tissue sample must be available for research purposes; providing a fresh tumour biopsy is optional but strongly encouraged if the doctor considers it safe and possible.
- People who have recovered from side effects of any previous cancer treatments, back to their baseline health or to a mild level, unless any remaining side effects are minor and stable with supportive care.
- Women who could become pregnant must have a negative blood pregnancy test within 72 hours before starting treatment, unless they have had a documented permanent surgical procedure to prevent pregnancy or are confirmed to be postmenopausal (confirm with trial site for specific hormone test requirements).
- Women who could become pregnant and men whose partners could become pregnant must agree to use abstinence or two forms of contraception (both a hormonal and a barrier method) from before starting the study, throughout participation, and for 6 months after finishing treatment.
- Men who could father a child must agree not to father a child or donate sperm during the study and for 6 months after the last study treatment.
- People who have adequate organ function as determined by blood tests (confirm with trial site for specific values required).
- People who test negative for HIV, or who test positive but are stable on anti-HIV medication, have an adequate immune cell count, and have an undetectable viral load, and are willing to continue their anti-HIV treatment throughout the study.
- People who test negative for hepatitis B (HBV) and hepatitis C (HCV), or who test positive but meet specific conditions: for HBV, the virus level in the blood must be below a set level and the person must have been on anti-HBV treatment for at least 14 days before starting the study and be willing to continue it; for HCV, the person must be receiving antiviral treatment and their liver function must have improved to a mild or better level.
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 currently enrolled in, or planning to enrol in, another therapeutic clinical trial at the same time.
- People currently using or planning to use other experimental treatments during this study.
- People who received an experimental treatment within 28 days before starting this study.
- People with a psychiatric illness or personal circumstances that would make it difficult to follow the study requirements.
- People who have had a severe (high-grade) active viral, bacterial, or fungal infection in the 2 weeks before the first study dose.
- People whose cancer has specific targetable genetic changes (such as in EGFR, ALK, or BRAF) and who have not yet had at least one frontline targeted therapy fail, or who have already received other systemic treatments such as chemotherapy or immunotherapy.
- People whose cancer has spread to the membranes surrounding the brain or spinal cord (leptomeningeal metastasis).
- People who have had major surgery within 2 weeks before starting the study, or whose surgical wound has not fully healed.
- People who have another active cancer that could affect their safety, interfere with study medications, or make it harder to interpret results — though people with certain types of apparently cured, localised cancers (such as some skin cancers, superficial bladder cancer, or early-stage cancers of the prostate, cervix, or breast) may still be considered (confirm with trial site).
- People who have previously been treated with cabozantinib and/or atezolizumab (the study drugs).
- People who received a small molecule kinase inhibitor (a type of targeted cancer drug, including experimental ones) within 2 weeks before the first study dose.
- People who received any cytotoxic, biologic, or other systemic anticancer therapy (including experimental therapies) within 4 weeks before the first study dose.
- People who received radiation therapy within 4 weeks before the first study dose, or systemic treatment with radioactive substances within 6 weeks before the first study dose, or who have ongoing significant complications from prior radiation therapy.
- People with known cancer spread to the brain or the area around the brain, unless it has been adequately treated and has been stable for at least 4 weeks, the person is neurologically symptom-free, and steroid use is at or below a low specified dose at the time of the first study dose.
- People taking certain blood-thinning medications, including warfarin, dabigatran, betrixaban, or clopidogrel — though some specific blood thinners at certain doses may be allowed (confirm with trial site).
- People who have received a live attenuated vaccine (such as the nasal flu vaccine) within 4 weeks before starting treatment, during treatment with atezolizumab, or within 5 months after the last dose of atezolizumab.
- People with uncontrolled or significant heart or blood vessel problems.
- People who have had clinically significant bleeding (for example, coughing up more than half a teaspoon of blood, or other significant bleeding events) in the 12 weeks before the first study dose.
- People whose cancer is growing into or wrapping around major blood vessels.
- People with other significant medical conditions that would make study participation unsafe.
- People who have had major surgery within 2 weeks, or minor surgery within 10 days, before the first study dose, or whose surgical wounds have not fully healed, or who have ongoing significant complications from prior surgery.
- People who are pregnant or breastfeeding.
- People who are unable to swallow tablets, or unable or unwilling to receive treatment given through an IV (intravenous drip).
- People with a known allergy or severe reaction to the components of the study drugs, or who have had a severe reaction to similar antibody-based treatments in the past.
- People with cancer pain that is not adequately controlled.
- People with uncontrolled fluid build-up around the lungs, heart, or abdomen that needs to be drained more than once a month — though people with a permanent drainage catheter in place may still be considered (confirm with trial site).
- People with uncontrolled or symptomatic high calcium levels in the blood.
- People with an active or past history of autoimmune disease or immune deficiency conditions, including but not limited to conditions such as lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, or similar conditions.
- People who had a severe infection within 4 weeks before starting treatment, including being hospitalised for an infection, a blood infection, or severe pneumonia.
- People who received antibiotic treatment (taken by mouth or by IV) within 2 weeks before starting treatment — though people taking antibiotics for prevention purposes (such as to prevent urinary tract infections) may still be considered (confirm with trial site).
- People who have previously been treated with certain immune-boosting or immune checkpoint cancer therapies, including anti-CTLA-4, anti-PD-1, or anti-PD-L1 antibody treatments.
- People who received systemic immune-stimulating treatments (such as interferon or IL-2) within 4 weeks, or within 5 half-lives of the drug (whichever is longer), before starting treatment.
- People with any serious or uncontrolled illness, active or uncontrolled infection, or other medical history that, in the investigator's opinion, would likely interfere with the person's participation or with interpreting the study results.
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
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Jun Zhang, MD, PhD
Registry
ClinicalTrials.gov
Start date
1 December 2024
Est. completion
1 June 2026
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Objective response rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 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.