Printed from Voxsanity (voxsanity.com.au) — NCT07360132 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Lung Cancer
Phase 3 Lung Cancer Trial, Not Yet Recruiting
NCT07360132
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 able to fully understand and voluntarily sign a consent form, and who are willing and able to follow the study procedures and attend follow-up visits.
- People who have a good general level of physical functioning, rated 0 or 1 on a standard cancer performance scale (meaning fully active or able to carry out light work).
- People whose doctors expect them to survive for at least 12 weeks.
- People who have been confirmed by a tissue or cell test to have locally advanced (Stage IIIB or IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that cannot be treated with surgery, and is not suitable for combined chemotherapy and radiotherapy or immunotherapy as a follow-up treatment.
- People who have not previously received systemic anti-cancer treatment for locally advanced or metastatic squamous NSCLC — or, if they did receive earlier treatment intended to cure non-metastatic disease, their cancer must have progressed more than 12 months after that treatment ended.
- People who are able to provide a tumor tissue sample (either archived or newly collected) taken at or after the diagnosis of locally advanced or metastatic disease, for laboratory testing of a protein called PD-L1.
- People whose tumor does not have certain specific gene changes (called sensitive EGFR mutations or ALK rearrangements), confirmed by prior test reports or by testing before joining the trial.
- People who have at least one measurable tumor lesion (not in the brain) that can be measured repeatedly and accurately using standard imaging guidelines (RECIST v1.1).
- People whose blood, kidney, liver, and heart function meet specific laboratory thresholds confirmed during screening (confirm exact values with the trial site).
- People whose side effects from any previous cancer treatment have recovered to a mild or absent level before joining the trial.
- People of childbearing potential who agree to use effective contraception from the screening period until at least 90 days after the last dose of study treatment, and female participants who are not breastfeeding and who have a negative pregnancy test within 7 days before joining the trial.
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 tumor contains small cell carcinoma, neuroendocrine carcinoma, or sarcoma components on tissue testing (note: mixed-type NSCLC such as adenosquamous carcinoma is permitted).
- People whose cancer has known gene changes for which approved first-line treatments already exist, such as sensitive EGFR mutations, ALK fusion, ROS1 fusion, BRAF V600 mutation, NTRK fusion, MET exon 14 skipping mutation, or RET fusion.
- People who have had another separate cancer diagnosed within the 3 years before joining the trial (some early-stage or locally treated cancers that are considered cured may still be eligible — confirm with the trial site).
- People who have brain metastases causing symptoms, or who have received brain radiotherapy within 2 weeks before joining, or who are expected to need brain radiotherapy during the first treatment cycle (people with stable, symptom-free brain metastases meeting specific criteria may still be considered — confirm with the trial site).
- People who have previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1 or anti-CTLA-4 treatments), immune checkpoint activators, or cell-based immunotherapy — though people who received certain immunotherapy as earlier consolidation or neoadjuvant/adjuvant treatment and whose disease progressed more than 12 months after the last dose may be considered with sponsor approval.
- People who have previously received systemic treatments that target the growth of blood vessels in tumors, such as bevacizumab, Endostar, certain targeted small molecule drugs, or ramucirumab.
- People who are currently enrolled in another interventional clinical trial, unless at least 4 weeks have passed since the last dose from that study.
- People who have received high-dose chest radiotherapy (more than 30 Gy) within 180 days before joining, high-dose non-chest radiotherapy within 4 weeks before joining, or low-dose palliative radiotherapy within 2 weeks before joining.
- People who have used certain herbal medicines with anti-cancer indications within 1 week before joining, or certain immune-boosting therapies within 2 weeks before joining.
- People who have needed ongoing steroid medicines at a moderate or higher dose (10 mg/day prednisone or equivalent) or other immune-modifying drugs within 2 weeks before joining (short-term or topical use may be permitted — confirm with the trial site).
- People who are currently on blood-thinning or anti-clotting medications and have not yet reached a stable, safe level of treatment before joining (people already on stable anticoagulant therapy within a safe therapeutic range may be considered — confirm with the trial site).
- People who have had major surgery or a serious injury within 4 weeks before the first dose, have not fully recovered from prior surgery, are expected to need major surgery during the study, have had minor local procedures within 7 days before joining, or have wounds that have not fully healed.
- People who have an active autoimmune disease that has required systemic treatment within the past 2 years (hormone replacement therapies for certain conditions may be permitted — confirm with the trial site).
- People who have had a severe infection requiring hospitalisation within 4 weeks before the first dose, an active infection requiring antibiotics within 2 weeks before joining, known active tuberculosis, known active syphilis, a known history of HIV, or active hepatitis B or C (people with certain low-level or clinically cured hepatitis B or C may be considered — confirm with the trial site).
- People with a known allergy or sensitivity to protein-based drugs, recombinant proteins, any component of the study drug HB0025, or the chemotherapy drugs used in this trial (pemetrexed and carboplatin/cisplatin).
- People with high blood pressure that cannot be controlled with standard treatment (systolic pressure at or above 160 mmHg or diastolic pressure at or above 100 mmHg).
- People who have previously needed steroid treatment for non-infectious lung inflammation, or who currently have certain lung conditions such as interstitial lung disease, pneumoconiosis, or drug- or radiation-related lung inflammation, or who have severely reduced lung function on breathing tests.
- People who have had significant bleeding events (including coughing up blood, gastrointestinal bleeding, or nosebleeds) within 4 weeks before the first dose, or certain artery or blood vessel problems within 6 months before the first dose, or deep vein clots within 3 months before the first dose.
- People whose scans at screening show that the tumour is growing into or around major blood vessels or vital organs, or where there is a risk of an opening forming between the oesophagus and the airway or chest cavity, or where tumour lesions appear to carry a significant bleeding risk.
- People with a history of ongoing or past bleeding disorders or problems with blood clotting.
- People who have had significant heart or stroke-related events within 6 months before the first dose, including heart attack, heart failure, poorly controlled irregular heartbeat, or stroke, or who have an abnormal heart electrical reading (QTcF above 480 ms) or a history of a specific inherited heart condition affecting heart rhythm.
- People who have had conditions that could cause bowel bleeding or perforation within 6 months before the first dose, or who have ongoing Crohn's disease or ulcerative colitis (even if currently in remission), unless they have had their entire colon and rectum removed.
- People with a history of a fistula (an abnormal opening or connection) in the gastrointestinal or urinary/reproductive tract that has not healed after surgery.
- People with a blocked kidney causing fluid build-up that has not been relieved by medical procedures, or an infected blocked kidney or urinary tract.
- People who currently have significant fluid build-up in spaces around the lungs, heart, or abdomen that requires repeated draining, or who have had such drainage within 2 weeks before the first dose.
- People who have had a sudden worsening of chronic obstructive pulmonary disease (COPD) within 30 days before the first dose.
- People who currently have other serious uncontrolled medical conditions, including severe liver cirrhosis, nephrotic syndrome, uncontrolled metabolic conditions, or severe active stomach ulcers or gastritis (confirm with the trial site).
- Women who are pregnant or breastfeeding, or who plan to breastfeed during the study.
- People who have had an organ transplant or a bone marrow/stem cell transplant from a donor.
- People who have received a live or weakened live virus vaccine within 30 days before joining, or who plan to receive one during the study (inactivated vaccines are permitted).
- People with a known history of serious mental illness, alcoholism, drug misuse, or substance abuse.
- People who have current or past uncontrolled medical conditions, abnormal test results, or other circumstances that could put them at higher risk or affect the reliability of the study results, as assessed by the study doctors.
- People who, for any other reason assessed by the study doctors, are considered not suitable to take part in this trial.
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: +86 021-58822171
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 3
Sponsor
Shanghai Huaota Biopharmaceutical Co., Ltd.
Registry
ClinicalTrials.gov
Start date
15 January 2026
Est. completion
10 April 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression-free survival (PFS)
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.