Printed from Voxsanity (voxsanity.com.au) — NCT07633873 — 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
NCT07633873
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
- Adults aged 18 to 75 years old, male or female.
- People with a laboratory-confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (a specific type of lung cancer), including certain advanced stages that are not suitable for surgery or intensive radiation treatment, or the most advanced stage of the disease.
- People who have not previously received systemic (whole-body) treatment for their cancer — though those who had earlier preventive or pre-surgery treatment may still be considered if their cancer came back more than 12 months after that treatment ended.
- People whose cancer tests negative for two specific genetic markers known as EGFR mutation and ALK fusion.
- People whose cancer shows a certain level of a protein called PD-L1 (a score of 1% or higher), as measured by a central laboratory test.
- People who have at least one tumour that can be measured on a CT or MRI scan, according to standard medical 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 work).
- People with a life expectancy of at least 3 months.
- People whose major organ functions (such as liver, kidneys, and blood) meet required levels within 7 days before starting the trial treatment.
- Women who could become pregnant must have a negative blood pregnancy test within 7 days before the first dose, and all participants must agree to use effective contraception from the time of signing consent until 7 months after the last dose; women must not breastfeed during this period, and men must not donate sperm during this period.
- People who are willing to take part voluntarily, understand what the study involves, and are able to sign a written consent form.
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 features of certain specific tumour types, including small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma, confirmed by tissue or cell testing.
- People whose cancer has specific genetic changes, including ROS1, RET, or NTRK fusions, a MET exon 14 skipping mutation, or a BRAF V600E mutation.
- People with cancer that has spread to the membranes around the brain or spinal cord, the brainstem, the spinal cord itself, or with active brain metastases — though people with certain treated and stable brain metastases that meet specific conditions as assessed by the trial site may still be considered.
- People who have had another type of cancer in the past 3 years, with some exceptions such as certain fully treated skin cancers, superficial bladder cancer, or certain in-situ cancers (confirm with trial site).
- People who are known to have an allergy to any ingredient in the trial drugs (SYS6010, Enlonstobart, or Tislelizumab), to humanised monoclonal antibody products generally, or to the chemotherapy drugs Paclitaxel, Carboplatin, Pemetrexed, or Cisplatin.
- People who have previously been treated with a specific type of drug called a topoisomerase I inhibitor toxin ADC therapy.
- People who still have side effects from previous cancer treatment that have not resolved to a mild level (with some exceptions as judged by the trial doctor), or who had severe immune-related side effects during previous treatment, or who had to permanently stop a previous treatment because of immune-related side effects.
- People who have not completed the required waiting period after certain previous medications or treatments (confirm with trial site for specific timeframes).
- People who have had a serious heart or blood vessel (cardiovascular or cerebrovascular) event in the 6 months before starting the trial.
- People who have a history of certain lung conditions (interstitial lung disease or non-infectious pneumonitis) that were treated with steroids, who currently have these conditions, whose screening scans cannot rule these conditions out, or whose lung function tests show severe breathing or oxygen-transfer problems.
- People who have had a serious infection requiring hospitalisation in the 4 weeks before starting the trial, or who have an active infection requiring antibiotic treatment in the 2 weeks before starting the trial.
- People with active autoimmune diseases or a history of autoimmune diseases (such as ulcerative colitis or Crohn's disease) — though people with well-controlled type 1 diabetes or hypothyroidism managed only with hormone replacement may still be considered.
- People who have had fluid around the lungs or heart requiring medical treatment in the 2 weeks before starting the trial.
- People with active hepatitis B or hepatitis C infection, as defined by specific blood test results (confirm with trial site for details).
- People with a history of immune system deficiency, including a positive HIV test, other immune deficiency conditions, or a history of stem cell or organ transplant from a donor.
- People with other conditions the trial doctor considers unsuitable for participation, such as certain mental health conditions, poorly controlled high blood pressure, or poorly controlled 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
2 June 2026
Est. completion
30 September 2027
Primary endpoints
Progression Free Survival (PFS) assessed by IRC
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 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.