Printed from Voxsanity (voxsanity.com.au) — NCT07318883 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Lung Cancer Trial, Not Yet Recruiting
NCT07318883
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 take part voluntarily, have been fully informed about the study, have signed a consent form, and are able to follow all study procedures.
- Adults aged 18 or older at the time of signing the consent form.
- People who have been diagnosed through laboratory tissue testing with a specific type of lung cancer called squamous non-small cell lung cancer (sqNSCLC) at an advanced or spread stage (stage IIIB, IIIC, or IV), where surgery or high-dose radiation therapy to cure the cancer is not an option.
- People who are able to provide enough tumour tissue samples that meet the quality standards needed to test for certain markers (EGFR and PD-L1 levels).
- Tissue samples provided should be from tumour sites that have not been treated with radiotherapy, collected at or after the diagnosis of advanced or spread sqNSCLC — ideally from within the past six months — along with the relevant pathology reports (confirm with trial site for detailed sample requirements).
- People who have not previously received systemic (whole-body) treatment for advanced or spread sqNSCLC; people who have had earlier adjuvant or neoadjuvant therapy may be considered if that treatment was completed at least 6 months before the advanced or spread diagnosis.
- People whose prior non-systemic anti-tumour therapy or Chinese herbal anti-tumour therapy ended at least 2 weeks before joining the study, and whose side effects from that treatment have largely resolved (confirm with trial site for specific grading details).
- People who have at least one measurable tumour lesion confirmed by a review process in the 4 weeks before joining the study, as assessed using standard criteria (RECIST v1.1).
- People with a general health and activity level scored at 0 or 1 on a standard scale (ECOG performance status) within 7 days before joining the study, meaning they are fully active or have only minor restrictions on physical activity.
- People with a life expectancy of at least 12 weeks.
- People with certain hepatitis B test results that fall within acceptable ranges, as defined by the trial (confirm with trial site for specific values).
- People who test negative for the hepatitis C antibody, or — if positive — test negative for active hepatitis C virus before joining; people with both hepatitis B and hepatitis C infections are not eligible.
- People whose major organ functions (such as liver, kidneys, and blood counts) meet the required levels set by the trial (confirm with trial site for specific values).
- Women who are post-menopausal (no periods for at least 1 year with no other medical cause), or who have had surgical removal of the ovaries and/or uterus, or — if able to become pregnant — who have a negative pregnancy blood test within 7 days before joining and agree to use highly effective contraception or remain abstinent from signing the consent form until at least 6 months after the last dose, and who agree not to donate eggs or breastfeed during this time.
- Men who agree to remain abstinent or use effective contraception during treatment and for at least 6 months after the last dose, and who agree not to donate sperm during this period.
- People who have previously received a bone-strengthening medication called denosumab for bone metastases and who are willing to switch to a different type of bone-strengthening medication called bisphosphonates, if the trial site determines this is appropriate.
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 lung cancer is confirmed to be a non-squamous type; people whose tumour contains small cell or neuroendocrine components are not eligible (mixed tumours are classified by the main cell type, and tumours where squamous cells are the main type may still be considered).
- People whose cancer has a known gene change (such as EGFR-sensitising mutation, ALK or ROS1 rearrangement, or other known driver mutations) for which locally approved targeted first-line treatments exist.
- People who have had another cancer within the past 5 years or have a currently active cancer, although people with certain localised cancers that have been fully treated (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, or breast cancer in situ) may still be considered.
- People who have had, or are scheduled to have, an organ or bone marrow transplant.
- People with fluid build-up around the lungs, heart, or abdomen that cannot be adequately controlled.
- People with active brain metastases or cancer spread to the lining of the brain or spinal cord found at screening, except in specific circumstances: people with small, symptom-free brain metastases (no symptoms, no need for steroid medications, and lesion size no larger than 1.5 cm) may be considered; people with previously treated brain metastases that have been stable for at least 1 month, with no new or growing lesions, and who have stopped steroid medication at least 3 days before joining, may also be considered (confirm with trial site).
- People with spinal cord compression that has not been fully treated with surgery and/or radiotherapy.
- People who have significant coughing up of blood combined with a blockage of the main vein in the chest (superior vena cava syndrome).
- People who have had a heart attack within the past 6 months, or who have poorly controlled irregular heartbeat, including certain abnormal heart rhythm measurements on an ECG.
- People with significantly reduced heart function, classified as NYHA Class III or IV heart failure, or with a reduced heart pumping measurement below 50% on an echocardiogram (heart ultrasound).
- People with high blood pressure that is not adequately controlled (systolic pressure at or above 150 mmHg and/or diastolic pressure at or above 100 mmHg), especially with a history of hypertensive crisis or hypertension affecting the brain.
- People with moderate or severe nerve damage in the hands or feet (Grade 2 or higher peripheral neuropathy).
- People with HIV infection.
- People with active tuberculosis of the lungs.
- People with a history of or currently active lung inflammation conditions such as interstitial pneumonia, dust-related lung disease, radiation-related lung damage, or drug-related lung damage, or who have severely reduced lung function that could make it hard to detect or manage potential lung side effects from the study treatment.
- People with a known active or suspected condition where the immune system attacks the body (autoimmune disease); people with a history of autoimmune disease that has not required immune-suppressing treatment for at least 12 months before screening may be considered.
- People who have received a live vaccine within 28 days before joining the study (standard inactivated flu vaccines and COVID-19 vaccines are generally permitted, but live nasal spray flu vaccines are not).
- People who require treatment with steroid medications above a certain dose (more than 10 mg/day prednisone equivalent) or other immune-suppressing drugs within 14 days before joining or during the study, with some exceptions for low-dose or locally applied steroids (confirm with trial site).
- People who have an active infection currently requiring antibiotic, antiviral, or antifungal treatment, or who have received such treatment within 14 days before joining.
- People who have had major surgery within 28 days before joining the study, where major surgery is defined as any operation requiring at least 3 weeks of recovery before starting the study treatment; people who have had only a needle biopsy or lymph node biopsy may still be considered.
- People who have had high-dose (radical) radiotherapy within 3 months before joining; certain palliative (symptom-relief) radiotherapy to bones or surface lesions completed at least 2 weeks beforehand may be permitted, but radiotherapy covering a large portion of the bone marrow within 28 days is not allowed (confirm with trial site).
- People who have previously received immune checkpoint treatments (such as medications targeting PD-1, PD-L1, or CTLA-4), or prior systemic anti-EGFR antibody therapy.
- People currently taking part in another clinical trial, or whose last treatment in a previous clinical trial ended less than 14 days before the planned start of treatment in this study.
- People with a known history of severe allergic reactions to any monoclonal antibody medication.
- People with a known allergy to carboplatin or paclitaxel (or nab-paclitaxel), which are chemotherapy drugs used in this trial.
- Women who are pregnant or currently breastfeeding.
- People with a known history of misuse of psychiatric medications, illicit drugs, or alcohol.
- People who, in the opinion of the investigator, have any other factor that may cause them to leave the study early.
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: +86-021-33395800
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 Henlius Biotech
Registry
ClinicalTrials.gov
Start date
1 March 2026
Est. completion
1 January 2031
Where this trial is recruiting
🇨🇳 China
Primary endpoints
ORR assessed by BICR (part I); PFS assessed by BICR (part I); PFS assessed by BICR (part II); OS (part II)
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.