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Early Phase 1 Lung Cancer Trial, Not Yet Recruiting
NCT06685653
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
Applies to all participants:
- People who are able to understand the study and are willing to follow its procedures, and who voluntarily sign the consent form before screening begins.
- People aged 18 to 75 years old (inclusive); any gender is eligible.
- People who are willing to provide a tumor tissue sample for genetic testing and analysis of unique cancer markers (neoantigens).
- People whose physical functioning is rated as 0 or 1 on a standard cancer performance scale (ECOG), meaning they are fully active or have minor limitations in strenuous activity.
- People whose life expectancy is estimated to be at least 6 months.
- People who are willing to provide blood samples before and after treatment to check the body's immune response and other biological markers; blood samples taken during screening must be from someone who has not received a blood transfusion, blood products, or blood-stimulating medications in the 7 days before the sample is collected.
- People whose blood cell counts meet minimum levels (neutrophils ≥1.5×10⁹/L, lymphocytes ≥0.5×10⁹/L, platelets at or above the lower limit of normal, and haemoglobin ≥90g/L), with no blood products or growth factor medications used in the 14 days before starting the study treatment.
- People whose liver function blood test results are within acceptable ranges (bilirubin ≤1.5× normal upper limit, liver enzymes ALT and AST ≤2.5× normal upper limit, albumin ≥30g/L, and creatinine ≤1× normal upper limit), with no blood products or growth factor medications used in the 14 days before starting the study treatment.
- People whose blood clotting results are within acceptable ranges (INR ≤1.5 and APTT ≤1.5× normal upper limit), with no blood products or growth factor medications used in the 14 days before starting the study treatment.
- People whose heart pumping function (left ventricular ejection fraction) is at least 50%, with no blood products or growth factor medications used in the 14 days before starting the study treatment.
- People whose heart electrical activity reading (QTcF interval on an ECG) is below 470 milliseconds, with no blood products or growth factor medications used in the 14 days before starting the study treatment.
- Women who could become pregnant must have a negative pregnancy blood test taken within 7 days before the first dose, and must not be breastfeeding.
- Women who could become pregnant, and men whose partners could become pregnant, must agree to use contraception from the time of signing the consent form until 90 days after the last treatment session.
Applies to Part A only (surgery-related group):
- People who have had surgery to remove stage IIB, IIIA, or stage IIIB (N2) non-small cell lung cancer (NSCLC), confirmed by laboratory tissue analysis under the AJCC 8th edition staging guidelines.
- People who received 3 to 4 cycles of pre-surgery chemotherapy (containing platinum) combined with immune checkpoint inhibitor treatment, and whose surgical tissue analysis showed that a major pathological response (meaning less than or equal to 10% of living tumour cells remaining) was not achieved after complete tumour removal (R0 resection); or people who did not receive pre-surgery therapy but still required surgery to achieve complete tumour removal.
- People who have recovered from any complications after surgery, or whose complications are below a certain severity level (below Clavien-Dindo grade 3).
- People who show no signs of remaining disease on physical examination, chest and abdomen CT scan, and head MRI scan taken within 14 days before the first vaccine dose.
Applies to Part B only (advanced/metastatic group):
- People with locally advanced unresectable, or recurrent or metastatic NSCLC confirmed by laboratory tissue analysis.
- People whose cancer progressed during or after first-line platinum-based chemotherapy (with or without immunotherapy).
- People who have at least one measurable tumour lesion according to standard imaging criteria (RECIST 1.1); lesions that have previously been treated with radiotherapy cannot be used as the measured target unless clear growth is seen on imaging after radiotherapy.
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.
Applies to all participants:
- People whose cancer is confirmed to be small cell lung cancer (SCLC), a mix of SCLC and NSCLC, or any cancer type other than NSCLC.
- People whose cancer carries certain gene changes (such as EGFR or ALK mutations) for which approved targeted therapies are already available and accessible.
- People who have previously received immune cell therapies or tumour vaccine treatments, including treatments such as TILs, CAR-T, TCR-T, or other therapeutic cancer vaccines.
- People who have received a live attenuated vaccine within 28 days before screening, or who plan to receive one during the study or within 90 days after the last study treatment (inactivated vaccines are permitted).
- People assessed by the study doctor as being unsuitable for immunotherapy for any reason.
- People with autoimmune diseases, except for an underactive thyroid caused by autoimmune thyroiditis that is managed with hormone replacement therapy.
- People with evidence of an active tuberculosis infection within the 1 year before screening, regardless of whether it has been treated.
- People with a known or strongly suspected history of interstitial pneumonia, or evidence of active interstitial pneumonia seen on a chest CT scan during screening; or people with a known history of idiopathic pulmonary fibrosis or organising pneumonia (such as bronchiolitis obliterans or cryptogenic organising pneumonia).
- People who have had a severe infection requiring intravenous antibiotics, antifungal, or antiviral medications in the 28 days before screening; or people who have an active infection requiring intravenous antibiotics during the screening period.
- People with uncontrolled fluid build-up around the lungs or in the abdomen that required drainage within 14 days before screening.
- People with a known allergy to the study drug or any of its ingredients, or a history of severe allergic reactions to other vaccines.
- People with a history of another cancer in the past 5 years, with the exception of certain cancers considered fully treated (such as cervical carcinoma in situ, certain skin cancers, localised prostate cancer after complete removal, ductal carcinoma in situ after complete removal, and papillary thyroid cancer); hormone therapy for non-metastatic prostate or breast cancer is permitted.
- People with a known history of having received an organ transplant or bone marrow/stem cell transplant from another person.
- People with inherited or acquired immune system deficiencies (such as DiGeorge syndrome, severe combined immunodeficiency, Wiskott-Aldrich syndrome, ataxia telangiectasia, or common variable immunodeficiency), or people who are living with HIV.
- People with active hepatitis B (confirmed by specific blood test results during screening) or active hepatitis C (confirmed by specific blood test results during screening).
- People with poorly controlled or severe heart conditions, including significant heart failure (NYHA class III or IV), a heart attack within the 6 months before screening, unstable chest pain within 1 month before screening, a serious heart rhythm problem requiring treatment, or high blood pressure that remains poorly controlled (systolic ≥160mmHg or diastolic ≥100mmHg) despite adequate treatment.
- People with other circumstances the study doctor judges may affect the conduct or results of the study, such as concerns about a participant's ability to follow the study requirements, any condition that poses a safety risk, insufficient neoantigens found in the tumour tissue for vaccine preparation, or failure to successfully prepare the vaccine.
Applies to Part B only (advanced/metastatic group):
- People with active cancer spread to the lining of the brain and spinal cord (leptomeningeal disease), or brain metastases that are uncontrolled and have not been treated.
- People whose side effects from previous cancer treatment have not recovered to their pre-treatment level or to a mild level (grade 1 or below), except for hair loss and skin pigmentation changes; nerve-related side effects must have recovered to grade 2 or below.
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.
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.
Contact this trial
Phone: 86 13851761392
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
Early Phase 1
Sponsor
Nanjing Tianyinshan Hospital
Registry
ClinicalTrials.gov
Est. completion
30 November 2026
Primary endpoints
• Incidence of DLTs; • Safety endpoints
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 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.