Printed from Voxsanity (voxsanity.com.au) — NCT07560111 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Lung Cancer Trial, Recruiting
NCT07560111
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 have signed the consent form and are able to follow the study schedule and procedures.
- People aged 18 to 70 years old, of any gender.
- People diagnosed with a type of lung cancer called non-small cell lung cancer, who have previously tested negative for certain genetic mutations (EGFR, ALK, and ROS-1), and who either: have another type of actionable genetic mutation and have already tried at least one approved targeted treatment (with the treating doctor determining that further targeted therapy is not in the person's best interest), and whose cancer has not responded to platinum-based chemotherapy; or (confirm with trial site for any additional sub-criteria not listed here).
- People who have a tumour area that can be surgically removed to collect immune cells, where the tissue is larger than 150mm³, and where that area has either not received local treatments (such as radiotherapy or radiofrequency ablation) or the cancer has come back after such treatment.
- People who still have at least one measurable tumour remaining after the immune cell collection and tissue removal procedure.
- People with a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physical activity (confirm with trial site).
- People with an expected survival of more than 3 months.
- People with adequate blood counts and organ function.
- Women who have not gone through menopause or had sterilisation surgery must agree to use effective contraception from the start of treatment until one year after the cell infusion, and must have a negative pregnancy test during screening; men who have not had sterilisation surgery must agree to use effective contraception from the start of treatment until one year after the cell infusion.
- People who have no medical or surgical reasons preventing them from having an operation.
- People who have stopped all previous cancer treatments (including radiotherapy, chemotherapy, hormone therapy, targeted therapy, immunotherapy, tumour embolisation, or herbal/traditional medicine with anti-cancer indications) at least 28 days before the cell infusion; for certain targeted drugs, this period may be shortened to 5 half-lives of that drug (confirm with trial site).
- People who are willing and able to follow the study visit schedule and all study requirements.
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 taken part in another clinical drug or biological therapy trial, or received a similar cell therapy, within 28 days before the cell infusion.
- People who have more than one current or recent malignant (cancerous) condition, unless the additional cancer has been fully cleared and has been inactive for 5 or more years with very low risk of return, or was a type of non-melanoma skin cancer or early-stage cancer that was fully treated with no signs of return.
- People who have received a live attenuated vaccine after signing the consent form, or who are scheduled to receive one during the study.
- People who have not yet recovered from side effects of a previous procedure or treatment to a mild level or below (with exceptions for side effects such as hair loss that the treating doctor considers to pose no safety risk).
- People with a known allergy to streptomycin, ciprofloxacin, or micafungin, or to any ingredient in the infused product.
- People with uncontrolled serious health conditions, including uncontrolled high blood pressure despite standard treatment, or any unstable heart or blood vessel condition (such as a stroke, mini-stroke, heart attack, or unstable chest pain) within the 6 months before enrolment; significant heart failure with reduced pumping function; serious heart rhythm or electrical conduction problems requiring treatment; or significantly abnormal heart electrical test (ECG) results including a prolonged QTc measurement of 450ms or more.
- People with varicose veins in the oesophagus or stomach that need immediate treatment or are considered high-risk for bleeding, evidence of high blood pressure in the liver's blood vessels (including an enlarged spleen seen on imaging), or a past history of bleeding from such veins, unless a camera examination of the digestive tract (endoscopy) has been done within 3 months before enrolment.
- People with uncontrolled metabolic conditions such as poorly controlled diabetes, or other serious non-cancer organ or body-wide diseases that may increase medical risk or make it harder to assess survival outcomes.
- People with brain complications from liver disease, kidney problems caused by liver failure, moderately severe or worse cirrhosis (Child-Pugh class B or above), or liver failure.
- People with another serious organ disease or serious psychiatric (mental health) condition.
- People with an active infection in the body that requires treatment, including active tuberculosis, supported by positive blood cultures or imaging.
- People who are HIV-positive, have a positive syphilis blood test, or have currently active hepatitis A, B, or C infection — including people who carry the hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb) (confirm with trial site for exact carrier exclusions).
- People with active autoimmune diseases that still require steroid medication (more than 10mg per day of prednisone or equivalent) or other immune-suppressing drugs during the screening period.
- People who experienced a severe immune-related side effect (grade 3 or higher) during any previous immunotherapy treatment.
- People who have had an organ transplant from a donor, a stem cell transplant from a donor, kidney replacement therapy, or a previous T-cell or NK-cell therapy from a donor.
- People with pulmonary fibrosis, interstitial lung disease (whether past or current), acute lung disease, or obstructive or restrictive lung disease where a key breathing test result (FEV1) is 70% or below.
- People with fluid build-up in body cavities (such as around the lungs or in the abdomen) that cannot be controlled by drainage or other means before enrolment.
- People with brain or nervous system metastases (cancer spread to the brain) that are causing symptoms such as swelling of the brain, requiring steroid treatment, or that are continuing to grow — unless prior brain metastasis treatment has resulted in clinical stability on MRI for at least 2 months and steroid medication has been stopped for more than 4 weeks.
- People who are pregnant or breastfeeding.
- People whom the treating doctor considers unsuitable for enrolment for any other reason.
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
Recruiting
Phase
Phase 2
Sponsor
Shanghai Juncell Therapeutics
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 June 2027
Primary endpoints
Objective Response Rate; Progression-Free Survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 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.