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Phase 1 Lung Cancer Trial, Not Yet Recruiting
NCT07436858
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 a written consent form agreeing to take part.
- People aged 18 or older who are willing and able to follow the study procedures, as assessed by the study doctor.
- People whose general health and ability to carry out daily activities falls within a specific range on a standard scale used in cancer care (a score of 0 or 1 on the ECOG scale, meaning fully active or restricted in strenuous activity only).
- People who have a confirmed advanced-stage cancer diagnosis with either: a high level of a protein called HER2 on at least 10% of tumour cells (without a specific HER2 gene mutation), or a specific type of HER2 gene change (an "insertion" mutation) identified through a specialised genetic test called RNA sequencing.
- People whose cancer has continued to grow or spread after receiving at least one course of platinum-based chemotherapy, with or without immunotherapy, and who are about to start a new systemic (whole-body) treatment.
- People who are willing to provide a recent tumour tissue sample taken after their last treatment, where the sample is of sufficient size and quality.
- People who are able to undergo PET scan imaging.
- People who have measurable disease according to a standard set of cancer measurement guidelines (RECIST 1.1).
- People who have at least two measurable tumour areas, each measuring 2 cm or more in their longest dimension.
- People whose blood counts and organ function fall within acceptable ranges when tested within 21 days before the study tracer is given, including: platelet count of at least 100,000/mm³ (without a platelet transfusion in the 14 days before the first study dose); haemoglobin of at least 9.0 g/dL; neutrophil count of at least 1,500/mm³; liver enzyme levels within three times the normal upper limit (or five times if liver spread is present); bilirubin within 1.5 times the normal upper limit (with specific allowances for a condition called Gilbert's Syndrome or liver spread); and kidney function showing a clearance rate of at least 30 mL/min as calculated by a standard formula.
- People whose blood clotting test results are within 1.5 times the normal upper limit, or — for those taking certain blood thinners (coumarin-type anticoagulants) — whose clotting levels fall within the treatment range considered appropriate by the study doctor.
- Women under 50 years of age may be considered post-menopausal if they have had no periods for 12 or more months after stopping hormone treatments, and their hormone levels (LH and FSH) fall within the post-menopausal range.
- Women aged 50 or older may be considered post-menopausal if they have had no periods for 12 or more months after stopping all hormone treatments, or if their periods stopped more than one year ago due to radiation therapy or chemotherapy.
- Women on hormone replacement therapy (HRT) whose menopausal status is uncertain will need to either use an approved contraceptive method while continuing HRT during the study, or stop HRT long enough for post-menopausal status to be confirmed before joining — after which HRT may be resumed without contraception being required.
- Women of childbearing potential who are sexually active with a male partner who has not been sterilised must use at least one highly effective contraceptive method from the time of screening and for 7 months after the last dose of the study treatment; breastfeeding must be avoided during the study and for 7 months after the last dose; complete abstinence from heterosexual sex throughout the study and washout period is acceptable if it reflects the person's usual lifestyle, but periodic abstinence, the rhythm method, and withdrawal are not accepted.
- Female participants must not donate eggs or retrieve eggs for personal use from the time of screening, throughout treatment, and for at least 7 months after the last study drug dose.
- Highly effective contraceptive methods (those with less than 1% failure rate) accepted in this trial include: complete abstinence from heterosexual sex (assessed in relation to the study duration and the person's usual lifestyle); a vasectomised partner (where that partner is the only sexual partner and has had medical confirmation of a successful vasectomy); surgical blockage of both fallopian tubes; a copper intrauterine device (IUD); combined hormonal contraception (containing both oestrogen and progestogen) that prevents ovulation, taken orally, vaginally, or via a skin patch; progestogen-only hormonal contraception that prevents ovulation, taken orally, by injection, or implant; or a hormone-releasing intrauterine system (IUS).
- All contraceptive methods must be used together with a condom worn by the male sexual partner during intercourse.
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 for whom systemic (whole-body) treatment would be medically unsuitable, as determined by the treating doctor.
- People who are pregnant or currently breastfeeding.
- People who have had an allergic reaction to immunoglobulins (a type of protein used in some medical treatments) or who have a known immunoglobulin allergy.
- People who are unable to follow the study procedures.
- People who have substance use issues or other medical conditions — such as significant heart or mental health conditions — that the study doctor believes could interfere with participation or the reliability of study results.
- People who have previously been treated with HER2-targeted therapies, with the exception of a class of drugs called pan-HER TKIs.
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: +31205129111
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
Sponsor
The Netherlands Cancer Institute
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
1 June 2030
Where this trial is recruiting
🇳🇱 Netherlands
Primary endpoints
Standard uptake values (SUVs) in tumor lesions
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 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.