Phase 1 Lung Cancer Trial, Recruiting
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 and dated a consent form agreeing to take part in the study.
- People aged 18 or older, of any gender.
- People who weigh at least 50 kilograms.
- People whose general health and ability to carry out daily activities meets a specific level of functioning, rated 0 or 1 on a standard medical scale (confirm with trial site).
- People who have been diagnosed through laboratory testing with either advanced or metastatic non-small cell lung cancer (a type of lung cancer that has spread), or another type of solid tumour cancer that has spread to the bones.
- People whose cancer has continued to grow or spread after receiving standard treatments, including platinum-based chemotherapy and immune checkpoint inhibitor therapy (for lung cancer), and for whom further standard cancer treatments are not suitable, not tolerated, or have been declined.
- People whose tumour has a known genetic change (such as EGFR, ALK, ROS-1, BRAF, RET, MET, or KRAS) must have already received a targeted therapy matched to that genetic change, and the cancer must have continued to grow despite that treatment.
- People who have at least one tumour that can be measured on a scan, based on standard imaging criteria — though people with cancer that has spread only to the bones are not required to have a measurable tumour.
- People whose side effects from previous cancer treatments have mostly resolved to a mild level or better (with hair loss being an exception).
- People with adequate blood, liver, and kidney function levels (confirm specific thresholds with trial site).
- People who agree to use effective contraception for up to 120 days after the last dose of the study drug.
- Women who could become pregnant must have a negative blood pregnancy test before joining.
- People whose cancer sites (both the original tumour and any spread) are suitable for a type of low-dose radiation therapy used in this trial (confirm with trial site).
- People with solid tumours that have spread to the bones (in a specific part of this trial) who are already receiving a bone-strengthening medication called zoledronic acid.
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 received chemotherapy, an experimental therapy, or an immune checkpoint inhibitor treatment within 30 days before the trial start date.
- People who have had major surgery within 30 days before the trial start date (minor procedures to place a vascular access device are excepted).
- People who have an active autoimmune disease that currently requires medication to suppress the immune system.
- People who have had an infection requiring treatment with systemic medication within 30 days before the trial start date.
- People with a history of fluid build-up in the abdomen, around the heart, or around the lungs.
- People with uncontrolled high blood pressure, a history of irregular heart rhythms (including atrial fibrillation), unstable chest pain, poorly controlled heart failure, reduced heart pumping function (ejection fraction of 50% or below), a previous heart attack, or abnormal heart electrical readings (prolonged QT/QTc interval).
- People who test positive for HIV, Hepatitis B, or Hepatitis C.
- People who are currently taking part in, or who completed, another clinical trial's treatment phase within 30 days before starting this study.
- People who have any other condition that the trial doctor believes would make participation in the study unsuitable.
- People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period.
- People who have a known allergy or intolerance to any ingredient in the study treatment.
- People who have received a live vaccine within 30 days before the trial start date.
- People who do not have the capacity to give consent for themselves.
- People who have a blockage of the large vein that carries blood from the upper body to the heart (superior vena cava obstruction).
- People who have received radiation therapy to a site being considered for treatment in this trial within 30 days before the trial start date.
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.
Contact this trial
Principal Investigator: Jason J Luke, MD, FACP, University of Pittsburgh
Phone: 1-844-539-2873
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
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
Primary endpoints
Number of participants with Adverse Events (AE) and/or Dose Limiting Toxicities (DLT) as a Measurement of Safety and Tolerability of KB-GDT-01 in Combination with LDRT
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.