Printed from Voxsanity (voxsanity.com.au) — NCT07092137 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07092137
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 been diagnosed with locally advanced (Stage IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that cannot be fully removed by surgery or treated with intensive radiation and chemotherapy combined, confirmed by tissue or cell testing.
- People who have been diagnosed with extensive-stage small cell lung cancer (SCLC), confirmed by tissue or cell testing, based on recognised staging systems (excluding mixed small cell lung cancer).
- People who have not previously received chemotherapy for metastatic disease, or who received earlier chemotherapy or chemoradiotherapy aimed at curing non-metastatic disease and experienced disease progression more than 6 months after finishing that treatment.
- People who have at least one measurable tumour that can be assessed using standard imaging criteria (RECIST v1.1).
- People who meet the criteria for pre-cachexia, meaning all three of the following apply: unintentional weight loss of 5% or less in the past 6 months, signs of body-wide inflammation (a blood marker called CRP above 5 mg/L), and reduced appetite as measured by a specific questionnaire score (FAACT-A/CS 12 score of 37 or below).
- People who meet the criteria for cachexia, meaning they have reduced appetite (FAACT-A/CS 12 score of 37 or below) or body-wide inflammation (CRP above 5 mg/L), along with either unintentional weight loss of more than 5% in the past 6 months, or weight loss of more than 2% when their body mass index (BMI) is below 18.5 kg/m².
- People who are willing to follow the study requirements and have signed a consent form agreeing to take part.
- People aged 18 to 75 years, of any gender.
- People with a general health and activity level rated 0, 1, or 2 on a standard scale used by doctors to measure how cancer affects daily functioning (ECOG performance status).
- People whose life expectancy is at least 6 months.
- People whose blood cell counts meet minimum levels: neutrophils (a type of white blood cell) at or above 1.5×10⁹/L, haemoglobin (a measure of red blood cells) at or above 9 g/dL, and platelets at or above 100×10⁹/L.
- People whose liver function blood test results fall within acceptable ranges as defined by the trial (confirm specific values with trial site), and whose blood albumin (a protein) level is at or above 3 g/dL.
- People whose blood clotting test results fall within acceptable ranges as defined by the trial (confirm with trial site).
- People whose kidneys are filtering blood at a rate of at least 60 mL/min, calculated using a standard formula.
- People whose urine protein levels are within acceptable limits as defined by the trial (confirm with trial site).
- People whose heart pumping function (left ventricular ejection fraction) is at or above 50%.
- Women who could become pregnant must have a negative pregnancy test within 3 days before starting the study drug, and must use an acceptable method of contraception from the screening period through to 120 days after the last dose of the study drug.
- Men who have not been sterilised and who are sexually active with women who could become pregnant must use effective contraception from the screening period through to 120 days after the last dose of the study drug.
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 active or untreated cancer spread to the brain or the lining of the brain or spinal cord, unless that spread has been treated, has been stable for at least 2 months, and steroid medication (above a certain dose) was stopped more than 4 weeks before the start of the trial.
- People who have cancer-related pain that is not currently controlled.
- People who have had a blood clot, fluid build-up in the abdomen (ascites), or swelling in the lower legs within the past 6 months.
- People who have had another type of cancer within the 5 years before joining the trial, with some exceptions for certain low-risk cancers that are considered cured after treatment (confirm specific exceptions with trial site).
- People who still have side effects from previous cancer treatment that have not recovered to an acceptable level (except hair loss).
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study.
- People with active hepatitis B infection based on specific blood test results, or active hepatitis C infection based on specific blood test results (confirm exact thresholds with trial site).
- People who have tested positive for HIV.
- People who have had major surgery (not including surgery done just for diagnosis) within 28 days before starting the trial, or who are expected to need major surgery during the study.
- People who have significant heart conditions, including moderate-to-severe heart failure (New York Heart Association class II or higher), a heart attack within 3 months before joining, unstable heart rhythm problems, unstable chest pain, stroke, or a temporary stroke-like event; or people with known coronary artery disease or certain other heart conditions who are not on a stable, optimised treatment plan.
- People who have had a serious infection within 4 weeks before starting the study drug, or an active infection requiring systemic antibiotic, antifungal, or antiviral treatment (other than treatment for hepatitis B or C) within 2 weeks before starting.
- People who have any condition that affects the ability to absorb food or medication through the gut, such as difficulty swallowing, malabsorption, uncontrollable vomiting, difficulty eating enough food, or a need for tube feeding or intravenous nutrition; or people with anorexia nervosa, loss of appetite due to a mental health condition, or eating difficulty caused by pain.
- People who are currently using or planning to use other medications intended to increase appetite or body weight, such as certain steroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or similar drugs.
- People who have Cushing's syndrome, adrenal or pituitary gland insufficiency, poorly controlled diabetes, or high blood pressure that remains above certain levels (systolic at or above 160 mmHg or diastolic at or above 100 mmHg) despite taking oral blood pressure medication.
- People who have a history, within 6 months before starting the study drug, of enlarged veins in the oesophagus or stomach, severe ulcers, a hole or abnormal opening in the gut wall, bowel obstruction, an abscess in the abdomen, or acute gastrointestinal bleeding.
- People who are known to be allergic to any ingredient in the study drug.
- People whom the trial investigators consider unsuitable for the trial for other reasons.
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: +8613632326736
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Guangzhou Institute of Respiratory Disease
Registry
ClinicalTrials.gov
Start date
10 October 2025
Est. completion
10 October 2026
Primary endpoints
The proportion of participants with a body weight increase of >5% relative to the baseline.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 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.