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Phase 3 Lung Cancer Trial, Not Yet Recruiting
NCT06828757
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 are willing to sign a written consent form, are 18 years of age or older, and have a physical fitness level rated between 0 and 2 on a standard oncology scale (meaning they are fully active to capable of limited self-care).
- People whose doctors expect them to live at least 6 months, and who have been diagnosed with advanced non-small cell lung cancer (NSCLC) that cannot be fully removed by surgery and cannot be treated with the standard combination of chemotherapy and radiation, or who have cancer that has spread to other parts of the body (stage IIIB, IIIC, or IV).
- People who have not yet received chemotherapy for their advanced or metastatic NSCLC — though people who received earlier chemotherapy as part of adjuvant, neoadjuvant, or radical treatment may be eligible if their cancer came back more than 6 months after that treatment ended.
- People who previously received certain immunotherapy drugs (called PD-1/L1 inhibitors) before surgery (neoadjuvant stage) may be considered for the trial after the investigator reviews and approves their case; however, people who received these drugs after surgery (adjuvant stage) or as consolidation treatment after chemoradiation are not eligible.
- People whose cancer does not have certain specific genetic changes known as EGFR-sensitive mutations or ALK gene translocations — for people with squamous NSCLC who smoke or have smoked, unknown EGFR and ALK status is considered acceptable (confirm with trial site).
- People who have at least one measurable area of cancer that can be reliably and repeatedly measured using standard imaging criteria.
- People who are considered at high risk of malnutrition based on a standard nutrition screening tool (a score of 3 or more on the Nutrition Risk Screening 2002 scale).
- People whose blood, kidney, liver, and heart are functioning well enough to meet the trial's specific laboratory requirements, including: sufficient levels of white blood cells, platelets, and haemoglobin; adequate kidney function and low urine protein; liver enzyme and bilirubin levels within acceptable ranges (with slightly higher limits allowed for people with liver involvement or a specific liver condition called Gilbert's disease); normal blood clotting levels (or within expected range if already on blood thinners); and a heart pumping function of at least 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 form of contraception from the screening period until 120 days after the last dose; men who are not surgically sterile and have a partner who could become pregnant must also use effective contraception from screening until 120 days after the last dose.
- People who are willing and able to attend scheduled visits, follow the treatment plan, complete required tests, and meet all other study requirements.
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 whose NSCLC has been found to have EGFR-sensitive mutations or ALK gene translocations, or whose cancer has a small cell carcinoma component identified under a microscope.
- People who have difficulty swallowing, problems absorbing food, uncontrollable vomiting, or any other condition affecting how food or medication is absorbed through the gut; people who are currently receiving tube feeding or nutrition through a drip; and people with anorexia nervosa, loss of appetite due to a psychiatric condition, or pain that makes eating very difficult.
- People who are currently taking or plan to take other medications intended to increase appetite or body weight, such as certain steroids (except short-term dexamethasone during chemotherapy), androgens, progesterone-type drugs, thalidomide, olanzapine, anamorelin, or other appetite-stimulating medicines.
- People with Cushing's syndrome, insufficient function of the adrenal or pituitary glands, or diabetes that is difficult to control.
- People who currently have a blockage in their digestive tract (gastrointestinal obstruction) based on imaging or symptoms.
- People who have had an active autoimmune disease requiring ongoing medical treatment (such as disease-modifying drugs, steroids, or immune-suppressing medicines) within the past two years; or people who have a current or past history of non-infectious lung inflammation (pneumonitis) or scarring of the lung tissue (interstitial lung disease) that required or requires steroid treatment.
- People who currently have serious uncontrolled health conditions, including but not limited to severe liver scarring (decompensated cirrhosis), kidney failure, uncontrolled metabolic disorders, severely active stomach ulcers or gastritis, or mental health or social conditions that would prevent them from following the study requirements or giving informed consent.
- People who were hospitalised in the 12 months before the first dose for unstable chest pain, heart attack, significant heart failure, or serious blood vessel disease (such as aortic aneurysm); or who have other poorly controlled heart conditions; or who have had certain serious digestive problems (including bleeding from oesophageal or stomach varices, severe ulcers, a hole or leak in the digestive tract, a blockage requiring drip nutrition, an abscess in the abdomen, or acute gastrointestinal bleeding) in the 6 months before the first dose.
- People who have had a serious blood clot in an artery, a severe vein clot (grade 3 or above, such as pulmonary embolism), a mini-stroke or stroke, a hypertensive crisis, or hypertensive brain swelling in the 6 months before the first dose; or who have had a sudden worsening of chronic lung disease (COPD) in the month before the first dose; or who currently have high blood pressure that remains at or above 160/100 mmHg even while taking blood pressure medication.
- People with a history of serious bleeding problems or clotting disorders; or who have had significant bleeding in the month before the first dose, including gastrointestinal bleeding or coughing up fresh blood or blood clots (people with blood-tinged sputum, as opposed to coughing up pure blood, may still be considered — confirm with trial site).
- People who have had a serious infection in the 4 weeks before the first dose, including infections requiring hospitalisation, blood poisoning (sepsis), or severe pneumonia; or who have had an active infection (other than hepatitis B or C antiviral treatment) requiring systemic antibiotic or antifungal treatment within 2 weeks before the first dose.
- People with any other current or past medical condition, treatment, or abnormal test result that could interfere with the study results, prevent full participation, or may not be in their best interest.
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
Hunan Province Tumor Hospital
Registry
ClinicalTrials.gov
Start date
1 May 2025
Est. completion
31 December 2026
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Appetite improvement level; Weight improvement level
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 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.