Printed from Voxsanity (voxsanity.com.au) — NCT07573696 — 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
NCT07573696
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 consent form agreeing to take part in the study
- People aged 18 or older at the time of signing the consent form
- People who are able to follow the study schedule and requirements
- People whose cancer is eligible to be treated with platinum-based chemotherapy according to local medical guidelines
- People who have been confirmed through laboratory testing of tissue samples to have locally advanced, inoperable Stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed
- Staging of the cancer must be based on Version 8 of a specific international lung cancer staging system (confirm with trial site)
- People who have a confirmed positive result for a specific genetic change called an ALK fusion, detected by an approved and validated test on tumour tissue performed in a certified laboratory — acceptable test types include next-generation sequencing, immunohistochemistry, fluorescence in situ hybridization, reverse transcription-polymerase chain reaction, or NanoString
- In China, only tests approved by the National Medical Products Administration (NMPA) for detecting ALK fusions are acceptable
- The specific gene partner involved in the ALK fusion must be identified, except in cases where the test type does not require this as part of its design (confirm with trial site)
- People with a general health status rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activities)
- People whose cancer can be measured using standard imaging criteria
- People with blood counts and organ function results within acceptable ranges, based on blood tests taken within 14 days before starting the study drug — specific thresholds include:
- White blood cell count (neutrophils) at or above a certain level, without the use of supporting medications
- Platelet count at or above a certain level, without needing a transfusion
- Haemoglobin at or above a certain level (transfusions or supportive treatments may be allowed to reach this level, as per local standard care)
- Liver enzyme levels (AST, ALT, and ALP) within an acceptable range
- Bilirubin within an acceptable range (a higher limit applies for people with a known condition called Gilbert disease)
- Kidney function, measured by creatinine clearance, at or above a certain level
- Albumin (a blood protein) at or above a certain level
- Blood clotting measures within an acceptable range for people not on blood-thinning medication; people already on blood-thinning medication must be on a stable regimen
- Women who could become pregnant must agree to use highly effective contraception (methods with less than 1% failure rate per year) or remain abstinent during treatment and for at least 90 days after the last dose of alectinib, and must also follow local guidelines for chemotherapy — acceptable methods include bilateral tubal ligation, male sterilisation, hormonal contraceptives that prevent ovulation, or certain intrauterine devices; oral contraceptives should be used with a barrier method such as a condom
- Women who could become pregnant must also agree not to donate eggs during this period
- Women should seek advice about fertility preservation before starting treatment
- Men must agree to use a condom plus an additional contraceptive method, or remain abstinent, during treatment and for at least 90 days after the last dose of alectinib when their partner could become pregnant; if their partner is already pregnant, men must use a condom or remain abstinent for the same period
- Men must agree not to donate sperm during this period
- Men should seek advice about fertility preservation before starting treatment
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 cancer or general health situation makes them ineligible for chemotherapy under local medical guidelines
- People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 90 days after the final dose of alectinib (or longer if required by local chemotherapy guidelines) — women who could become pregnant must have a negative blood pregnancy test before enrolling and within 7 days before the first dose
- People who have any prior history of NSCLC or who have previously received any treatment for NSCLC — only people newly diagnosed with inoperable Stage III disease are eligible
- People with any signs of Stage IV (more advanced/spread) disease, including fluid around the lungs (pleural effusion, unless it meets specific criteria below), fluid around the heart, brain metastases, history of bleeding in the brain or spinal cord, bone metastases, or cancer that has spread to distant parts of the body
- People with a pleural effusion (fluid around the lung) that is visible on both a CT scan and chest X-ray must have a sample of that fluid tested and confirmed to be free of cancer cells, and people with a certain type of effusion called exudative are excluded regardless of test results; only people whose effusion is very small and not visible on a chest X-ray, and too small to safely sample, may still be considered eligible
- People whose NSCLC has specific ALK gene mutations known as I1171X, V1180L, or G1202R
- People whose NSCLC has a known or likely cancer-driving mutation in the EGFR gene
- People with significant liver disease, including poor liver function, liver failure, or active liver inflammation from any cause (viral, autoimmune, alcohol-related, or other)
- People who test positive for hepatitis B surface antigen (a marker of active hepatitis B infection) at screening — people with a past resolved hepatitis B infection may be eligible only if a specific DNA test is negative (confirm with trial site)
- People who test positive for hepatitis C antibodies, unless further testing shows the virus is no longer active due to prior treatment or the body clearing the infection
- People living with HIV who have a low immune cell count (CD4+ below 350 cells per microlitre), who have been on HIV treatment for less than 4 weeks, who have a detectable HIV viral load at screening, or who have had a serious HIV-related infection in the past 12 months
- People with known active tuberculosis
- People with symptoms of an abnormally slow heart rate (symptomatic bradycardia)
- People who have had a significant heart or cardiovascular event — such as a heart attack or stroke — within the 3 months before starting the study, or who have an unstable heart rhythm or unstable chest pain; people with known heart disease or reduced heart pumping function below a certain level must be on a stable, optimised treatment plan as determined by their treating doctor
- People with a digestive condition that affects how the body absorbs oral medications, such as a malabsorption condition or having had a major bowel removal surgery
- People with any other serious illness, abnormal test finding, or physical condition that could make it unsafe to take the study drug, affect how results are interpreted, or put them at high risk of complications
- People with a history of certain lung conditions including idiopathic pulmonary fibrosis, organising pneumonia, drug-induced lung inflammation, or idiopathic pneumonitis, or who show signs of active lung inflammation on a CT scan at screening
- People who have had another cancer (other than NSCLC) within the 5 years before enrolling, with exceptions for certain low-risk cancers such as treated cervical carcinoma in situ, non-melanoma skin cancer, localised prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
- People currently receiving any other cancer treatment, including chemotherapy, immunotherapy, biologic therapy, or hormonal therapy (local treatment of specific non-target areas with palliative intent, such as local surgery or radiotherapy, may be acceptable — confirm with trial site)
- People who have had a major surgical procedure within 4 weeks before starting the study treatment
- People who have had a serious infection within 4 weeks before starting the study treatment, including hospitalisation for an infection, bacteria in the bloodstream, or severe pneumonia
- People who have received another experimental treatment within 28 days before starting the study treatment
- People who have previously been treated with an ALK inhibitor
- People with a known sensitivity or allergy to alectinib or any of the chemotherapy agents used in this trial, including people with certain rare inherited conditions affecting how the body processes sugars (such as galactose intolerance, congenital lactase deficiency, or glucose-galactose malabsorption)
- People currently enrolled in another clinical trial that involves an active treatment (participation in a non-interventional observational study or the follow-up phase of a previous interventional study may be acceptable)
- People who, in the opinion of the trial doctor, have any condition that could interfere with assessing how the study drug works or with evaluating safety
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.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: 86-020-83525815
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 2
Sponsor
Wen-zhao ZHONG
Registry
ClinicalTrials.gov
Start date
15 June 2026
Est. completion
8 February 2030
Primary endpoints
24-month EFS rate
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.