Printed from Voxsanity (voxsanity.com.au) — NCT07442565 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Lung Cancer Trial, Not Yet Recruiting
NCT07442565
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, understand what the study involves, and are able to sign a consent form.
- People aged 18 or older; there is no restriction on sex.
- People who have been confirmed by a tissue test to have a specific type of lung cancer — locally advanced or metastatic non-squamous non-small cell lung cancer (a type that is not driven by EGFR gene mutations) — either at an advanced stage not suitable for surgery or intensive radiation, or at the most advanced (Stage IV) level; EGFR mutations approved for targeted treatment must be confirmed absent, and if test results are not available, a tumour tissue sample will need to be provided for genetic testing.
- People whose cancer has been previously treated with either: (a) immunotherapy and platinum-based chemotherapy, with or without anti-blood-vessel-growth therapy (for those without other driver gene mutations), or (b) targeted therapy for their specific driver gene mutation plus platinum-based chemotherapy, with or without anti-blood-vessel-growth therapy — and whose cancer has stopped responding to that first-line treatment; only first-line regimens approved by regulatory authorities are counted.
- People who have at least one tumour that can be measured on a CT or MRI scan, according to standard measurement guidelines.
- People with a general health and activity level rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
- People whose doctor estimates they are expected to live for at least 3 more months.
- People whose blood counts and organ function meet specific levels when tested within 7 days before starting the trial (blood cell counts, kidney function, liver function, and clotting levels must all be within set ranges; certain blood-boosting treatments must not have been received in the 2 weeks before joining).
- Women of childbearing age must have a negative pregnancy test within 7 days before joining, and all participants must agree to use effective contraception from the time of signing the consent form until 7 months after the last dose; women must not be breastfeeding during this period, and men must not donate sperm during this period.
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 whose lung cancer has been confirmed as small cell lung cancer, squamous cell carcinoma, neuroendocrine carcinoma, or sarcomatoid carcinoma.
- People who have cancer that has spread to the lining around the brain, the brainstem, the spinal cord, or who have active brain metastases; an exception may apply for certain brain metastases in specific locations that have already been treated and have been stable for at least 2 weeks, with no or very low steroid use (confirm with trial site).
- People who have had another cancer in the 3 years before joining, except for certain fully treated skin cancers, superficial bladder cancer, or early-stage prostate or cervical cancer.
- People with a known allergy to any ingredient in the study drug SYS6010 or to humanised monoclonal antibody medicines, or who have a known allergy or intolerance to docetaxel (a chemotherapy drug used in this trial).
- People who still have side effects from previous cancer treatment rated above a mild level (with the exception of a certain level of hair loss, or other side effects the doctor considers low-risk).
- People who have previously been treated with a class of cancer medicines called topoisomerase I inhibitors, including certain antibody-drug combinations (ADCs) in this class.
- People who have not waited long enough since their last cancer treatment or surgery — specific waiting periods apply depending on the type of treatment received (confirm exact timeframes with trial site).
- People who have received an experimental drug or a live vaccine within 4 weeks before the first dose.
- People who have had a serious heart or blood vessel problem in the 6 months before joining, including significant irregular heart rhythms, a prolonged heart electrical interval, heart attack, unstable chest pain, aortic dissection, certain heart procedures, heart failure of a certain severity, stroke, or a blood clot in the lungs.
- People with a history of, or currently active, inflammatory lung disease (such as interstitial lung disease) that required steroid treatment, or where imaging or breathing tests suggest serious lung damage.
- People who have had a serious infection in the 4 weeks before joining, or who have an active infection currently requiring intravenous antibiotics.
- People with a history of ulcerative colitis or Crohn's disease.
- People who have had fluid around the lungs or heart that required a procedure to drain it in the 2 weeks before joining.
- People with an active hepatitis B or hepatitis C infection meeting specific test thresholds.
- People with a weakened immune system due to HIV, a genetic or acquired immune disorder, or who have had an organ or stem cell transplant from a donor.
- People who have other conditions that the trial doctor considers would make participation unsuitable, such as uncontrolled mental health conditions or uncontrolled high blood pressure or diabetes.
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.
Contact this trial
Phone: 031169085587
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Registry
ClinicalTrials.gov
Start date
10 March 2026
Est. completion
30 December 2027
Primary endpoints
PFS (Progression-Free Survival) assessed by IRC (Independent Review Committee) in the EGFR high-expression population.; OS (Overall Survival) in the overall population
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 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.