Printed from Voxsanity (voxsanity.com.au) — NCT07376382 — 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
NCT07376382
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 aged 18 to 75 years old (any gender).
- People who have been diagnosed through laboratory testing with locally advanced or metastatic non-small cell lung cancer (a type of lung cancer) that has spread or cannot be removed with surgery or treated with radiation, at a specific stage of severity.
- People whose lung cancer has a specific gene change called an EGFR mutation (either ex19del or L858R, which may also appear alongside other EGFR mutations) — the exact testing requirements differ depending on which part of the trial a person is entering (confirm with trial site).
- People who have at least one measurable area of cancer that can be seen on a CT or MRI scan, according to standard measurement guidelines.
- People who are well enough to carry out normal daily activities, with a fitness rating of 0 or 1 on a standard medical scale (ECOG scale).
- People whose doctors expect them to live for at least 3 more months.
- People whose major organs (blood, kidneys, liver, and clotting function) are working within acceptable ranges based on blood tests taken within the 7 days before starting 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 signing the consent form until 7 months after the last dose; women must not be breastfeeding during this time, and men must not donate sperm during this period.
- People who are willing to take part in the study, 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 cancer has spread to the lining of the brain, the brainstem, the spinal cord, or who have active cancer spread in the brain.
- People who have had another type of cancer in the past 3 years, unless it was a fully cured skin cancer (certain types), superficial bladder cancer, or very early-stage prostate or cervical cancer.
- People with a known allergy to the study drugs (SYS6010 or Osimertinib) or to a type of laboratory-made antibody used in treatment.
- People who still have significant side effects from previous cancer treatments that have not sufficiently improved (with some exceptions for certain types of hair loss or nerve-related symptoms, as assessed by the trial doctor).
- People who have used certain medications or treatments within specified time periods before the first dose (confirm with trial site for the specific medicines and timeframes).
- People who have had a serious heart or blood vessel problem in the 6 months before the first dose, including serious irregular heartbeats, heart attack, unstable chest pain, aortic tearing, heart bypass surgery, significant heart failure, stroke, or a blood clot in the lungs.
- People who have previously been treated with steroids for a lung inflammation condition (ILD or non-infectious pneumonitis), currently have this condition, cannot rule it out based on screening scans, or have severely reduced lung function on breathing tests.
- People who have had a serious infection requiring hospitalisation in the 4 weeks before the first dose, or who have had an active infection requiring antibiotics within 2 weeks before the first dose.
- People who currently have a skin condition that requires treatment given by mouth or through a vein.
- People with an active autoimmune disease or a history of autoimmune disease (such as ulcerative colitis or Crohn's disease), although people with well-controlled type 1 diabetes, well-controlled thyroid conditions managed only with hormone replacement, skin conditions not requiring whole-body treatment, or autoimmune conditions very unlikely to flare up may be considered for further screening (confirm with trial site).
- People who have fluid build-up around the lungs, abdomen, or heart that requires medical treatment.
- People with conditions that seriously affect how the gut absorbs medicines, such as ongoing nausea, vomiting, long-term digestive diseases, or previous gastrointestinal surgery, as assessed by the trial doctor.
- People with an active hepatitis B or hepatitis C infection based on specific blood test results (confirm with trial site for exact thresholds).
- People with a history of immune system deficiency, including a positive HIV test or other inherited or acquired immune conditions, or people who have had a stem cell or organ transplant from another person.
- People with other conditions the trial doctor considers unsuitable for participation, such as certain mental health conditions, specific eye conditions, poorly controlled high blood pressure or diabetes, or active bleeding.
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
1 June 2026
Est. completion
12 December 2026
Primary endpoints
Progression Free Survival(PFS) evaluated by IRC
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 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.