Printed from Voxsanity (voxsanity.com.au) — NCT07663630 — 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
NCT07663630
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 an informed consent form agreeing to take part in the study.
- People who have been confirmed by tissue or cell testing to have non-small cell lung cancer (NSCLC) that is locally advanced, cannot be surgically removed, and is classified as stage III disease.
- People whose cancer can be measured on scans at the time of screening.
- People who have finished a chemotherapy plus radiation treatment using platinum-based chemotherapy, completed between 7 and 42 days before joining the trial.
- People whose cancer has not gotten worse after completing their chemotherapy and radiation treatment.
- People who are due to receive a follow-up immune therapy drug called durvalumab for up to 12 months, with the first dose of the study treatment timed to coincide with the first dose of durvalumab (within 7 days either side).
- People whose cancer does not have certain specific gene changes (such as EGFR or ALK mutations) that would affect treatment options.
- People who meet the medical definition of cachexia (severe unintended weight loss) under the Fearon criteria — either a body mass index below 20 kg/m² with more than 2% unintended weight loss in the past 6 months, or more than 5% unintended weight loss over the past 6 months regardless of body weight.
- People who have already tried available treatments for cachexia (severe weight loss) with no benefit, or who have been assessed as not suitable for those treatments.
- People whose general physical health and ability to function has been assessed by the trial doctor as being at a good to moderate level (ECOG performance status of 0 or 1).
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 currently have treatable, reversible reasons for reduced food intake, as determined by the trial doctor — such as severe mouth sores (grade 3 or 4 oral mucositis) or physical blockages that make eating difficult.
- People who are currently receiving nutrition through a feeding tube or directly into a vein (tube feeding or parenteral nutrition) at the time of screening or when joining the trial.
- People who have ever been diagnosed with heart failure, regardless of how well their heart is functioning.
- People whose severe weight loss (cachexia) is caused by a condition other than NSCLC, such as severe chronic lung disease, as determined by the trial doctor.
- People whose lung cancer is a mixed type containing both small cell and non-small cell lung cancer.
- People who have had major surgery within 4 weeks before joining the trial, or who have major surgery planned during the study period.
- People who have previously had serious immune-related side effects from immunotherapy that required treatment with steroid medicines taken throughout the body (systemic corticosteroids).
- People who regularly use steroid medicines that work throughout the body (systemic corticosteroids) on an ongoing basis.
- People who have had another cancer diagnosed in the last 2 years, except for certain treated skin cancers or very early-stage cancers that have been adequately treated.
- People who have brain metastases or cancer spread to the lining of the brain or spinal cord that are causing symptoms.
- People who have severe lung disease unrelated to their cancer — including severe asthma needing systemic steroids, severe chronic obstructive pulmonary disease requiring extra oxygen or systemic steroids, clinically severe or very serious blood clots in the lungs within 3 months of the first study dose (including clots in the main or large lung arteries), or autoimmune or inflammatory conditions significantly affecting the lungs (such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis).
- People whose kidneys are not working well enough and who require dialysis, or whose kidney function test result falls below a certain level (eGFR less than 30 mL/min/1.73 m²).
- People with a history of serious liver disease or liver scarring (cirrhosis) unrelated to cancer, or whose liver function blood test results at screening are above certain levels indicating possible liver problems (confirm with trial site for specific values).
- People whose heart pumping function, measured by a heart scan at screening, is below 50% (left ventricular ejection fraction less than 50%).
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: Pfizer CT.gov Call Center, Pfizer
Phone: 1-800-718-1021
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
Registry
ClinicalTrials.gov
Start date
22 July 2026
Est. completion
2 February 2028
Primary endpoints
Percent change from baseline in Lumbar Skeletal Muscle Index
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 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.