Printed from Voxsanity (voxsanity.com.au) — NCT06941480 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Lung Cancer Trial, Not Yet Recruiting
NCT06941480
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 with a laboratory-confirmed diagnosis of advanced, spreading high-grade neuroendocrine cancer of the lung (small-cell lung cancer) or prostate (neuroendocrine prostate cancer) that has come back or continued to grow after at least one standard chemotherapy treatment.
- Prostate cancer patients may meet the disease definition through any of the following: a specific protein marker (chromogranin) found on tissue; at least two gene mutations in PTEN, RB1, or p53; cancer found only in internal organs; a PSA level below 10 with more than 20 bone lesions; laboratory evidence of small cell or neuroendocrine features on tissue; or a positive DLL3 result on previously collected tissue.
- People who are able to understand and are willing to sign a written consent form.
- People aged 18 years or older at the time of signing consent.
- People whose cancer has shown signs of growing within 3 months before entering the study, defined as at least a 20% increase in measurable disease on scans, the appearance of any new lesion, or — for prostate cancer — a rising PSA over at least two measurements one week apart, an increase in soft tissue disease, or two new bone lesions on a bone scan.
- People whose metastatic disease is visible on standard imaging scans (such as CT, MRI, or bone scintigraphy); disease detected only on PSMA PET scans does not meet this criterion.
- People who have at least one tumour lesion measuring 2 cm or larger on CT or MRI.
- People with an ECOG performance status of 0, 1, or 2 (a measure of general physical function; confirm with trial site if unsure what this means for a specific situation).
- Women who could become pregnant and men must agree to use adequate contraception before starting the study and for the full duration of participation.
- People who have had prior chemotherapy, immunotherapy, or investigational treatments are eligible provided those treatments were completed at least 4 weeks before entering the study, and that the cancer has been documented to have progressed since then.
- People with adequate blood counts: haemoglobin at least 9.0 g/dL, white blood cell count at least 3,000/mm³, neutrophils at least 1,500/mm³, and platelets at least 75,000/mm³.
- People with adequate kidney function: blood creatinine level no higher than 1.7 mg/dL and an estimated kidney filtration rate of at least 30 mL/min/1.73m².
- People with adequate liver function: liver enzyme levels (AST and ALT) no more than 3 times the upper limit of normal (or up to 5 times if liver metastases are present), and bilirubin no more than 1.5 times the upper limit of normal (unless due to a condition called Gilbert's syndrome or red blood cell breakdown).
- People who are willing to have a tissue biopsy at the start of the study and at follow-up points, to allow testing for DLL3 and genetic analysis.
- To receive the study treatment (177Lu-DTPA-SC16.56), a person's cancer must show high levels of a protein called DLL3 — confirmed by a specific type of scan — in at least 80% of the growing tumour lesions that are 2 cm or larger.
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 had a severe allergic (anaphylactic) reaction to humanised or human antibody-based medicines in the past.
- People who have had a severe allergic reaction to X-ray contrast dye even after being given medication to prevent it.
- People who have previously been treated with Rova-T (rovalpituzumab).
- Women who are pregnant or who are unwilling to stop breastfeeding.
- People with spinal cord compression or uncontrolled cancer affecting the area around the spine, unless it has been treated and has been stable for at least one week before enrolment.
- People of reproductive potential who are unwilling to use a highly effective method of contraception during the study and for 4 months after the last dose (for males) or 7 months after the last dose (for females); accepted methods include abstinence, vasectomy, bilateral tubal ligation or occlusion, or a condom with spermicide (for men) combined with hormonal contraception or an IUD (for women).
- People whose treating doctor estimates their life expectancy to be less than 6 months.
- People who still have unresolved side effects from previous cancer treatments that have not returned to mild (grade 1) or no symptoms (grade 0), as defined by standard medical criteria (CTCAE version 5.0).
- People who have had major surgery within 28 days before enrolment, with the exception of biopsy or insertion of a central venous catheter.
- People with uncontrolled ongoing illness, including active infection, heart failure with symptoms, unstable chest pain, irregular heart rhythm, or mental health or social circumstances that would make it difficult to follow the study requirements.
- People with known brain metastases or cancer spread to the membranes surrounding the brain or spinal cord, unless these have been treated and are stable.
- People with urinary incontinence that cannot be managed safely during treatment with 177Lu-DTPA-SC16.56 (for example, where a urinary catheter is not a feasible option).
- People with another active invasive cancer (not including certain low-risk cancers such as carcinoma in situ or non-invasive bladder cancer), or people with a previously treated cancer that has more than a 30% chance of coming back within the next two years.
- People who are unlikely to be available to complete all required study visits and procedures.
- People receiving concurrent chemotherapy, other radiopharmaceutical treatments of any kind, or immunotherapy at the same time as the study treatment.
- People who are taking complementary therapies known to affect PSA levels while on the trial.
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
Principal Investigator: Lisa Bodei, MD, PhD, Memorial Sloan Kettering Cancer Center
Phone: 212-639-7373
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 1
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 May 2030
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Maximum tolerated dose of 177Lu-DTPA-SC16.56
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.