Phase 2 Lung Cancer Trial, Not Yet Recruiting
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, sign a consent form, and are able to follow the study procedures.
- People aged 18 to 75 years (men and women are both eligible).
- People who have been confirmed by laboratory testing (from tissue or cell samples) to have stage IV non-small cell lung cancer (NSCLC), based on a specific medical staging system; if the cancer has mixed cell types, the classification must be based on the main type present.
- People whose cancer has tested negative for certain specific gene changes (EGFR mutations, ALK rearrangements, and ROS1 fusions), and where no approved targeted drug treatments are available for any other relevant gene changes that may have been found.
- Genetic testing results from a local or central laboratory are accepted, and existing valid test reports are also acceptable.
- People with a life expectancy of at least 3 months, and who have at least one area of measurable cancer confirmed by an independent review; areas that have been previously treated with radiation are generally not counted unless they have clearly grown.
- People who are relatively well and active on a standard health scale (called ECOG performance status 0 or 1, meaning fully active or restricted in strenuous activity only), and who have not previously received systemic treatment for advanced or metastatic NSCLC — except for chemotherapy given before or after surgery, as long as the last dose was at least 6 months before the cancer came back.
- People with blood and organ function results within acceptable ranges, tested within 14 days before joining the trial — including adequate levels of white blood cells, platelets, haemoglobin, kidney function, liver function, and heart function (confirm with trial site for specific values).
- Women who could become pregnant must have a negative pregnancy test within 14 days before enrolling, and both women who could become pregnant and male participants must agree to use effective contraception from signing the consent form until 180 days after the last dose.
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 had high-dose chest radiation (more than 30 Gy) within 6 months before the first dose, palliative radiation within 7 days before the first dose, or who need to continue other anti-cancer treatments during the study, or who have uncontrolled fluid build-up around the lungs, heart, or abdomen that keeps needing to be drained.
- People who have cancer spread to the brainstem, the lining of the brain or spinal cord, the spinal cord itself, or who have spinal cord compression.
- People with active cancer spread to the brain or the membranes surrounding the brain; however, people with previously treated and stable brain metastases may be considered if the condition has been clinically stable for at least 2 weeks, shows no signs of getting worse, and the person has been off steroid medications for at least 3 days before starting treatment.
- People who have previously been treated with certain types of immunotherapy drugs (including PD-1, PD-L1, or CTLA-4 inhibitors, immune-activating agents, or cell-based immunotherapy).
- People who have used certain traditional Chinese medicines or immune-modifying drugs with anti-cancer activity within 2 weeks before the first dose.
- People who have used steroid medications above a certain dose (more than 10 mg prednisone equivalent per day) or other immune-suppressing medications within 2 weeks before the first dose.
- People with an uncontrolled infection, an unexplained fever above 38.5°C, or who have needed intravenous antibiotics for more than 7 days within the 2 weeks before the first dose.
- People who have had another cancer in the past 5 years, with some exceptions such as certain early-stage or fully treated cancers including cervical carcinoma in situ, certain skin cancers, localised thyroid cancer, prostate cancer in remission, or a specific type of treated breast condition (DCIS) — confirm with the trial site.
- People with an active autoimmune disease or a history of autoimmune conditions (such as autoimmune hepatitis, lung inflammation, colitis, or thyroid disease, among others); however, people with controlled underactive thyroid managed with hormone replacement, and people with certain mild conditions such as vitiligo, hair loss, type 1 diabetes, resolved childhood asthma, or mild psoriasis not requiring systemic treatment, may still be considered.
- People with significant lung diseases, such as steroid-requiring lung inflammation, drug-induced lung inflammation, or moderate-to-severe chronic obstructive pulmonary disease (COPD).
- People who have had major surgery within 4 weeks before the first dose, or who still have unhealed surgical wounds.
- People with significant heart or blood vessel problems, including heart attack, unstable chest pain, stroke, or mini-stroke within the past 6 months; arterial blood clots within 6 months; deep vein clots, pulmonary embolism, or severe clotting within 3 months; uncontrolled high blood pressure; heart muscle inflammation; or severe heart failure.
- People with a history of bone marrow or organ transplant (except corneal transplant).
- People with moderate or severe nerve damage in the hands or feet (Grade 2 or above on a standard scale).
- People with active tuberculosis or tuberculosis that has not been ruled out.
- People who test positive for HIV; people with active syphilis or untreated positive syphilis screening results; or people with uncontrolled hepatitis B or C infection as defined by the trial protocol.
- People who have received a live vaccine within 30 days before the first dose, or who plan to receive one during the study.
- People with a history of serious allergic reactions to monoclonal antibody treatments, PD-1 drugs, or specific chemotherapy drugs used in this trial (pemetrexed or carboplatin), or to related pre-medications.
- People who are currently taking part in another interventional clinical trial, or who have used another experimental treatment or device within 4 weeks before the first dose.
- People with a history of drug or alcohol misuse, or uncontrolled mental health conditions that may affect their ability to follow the study requirements.
- People whom the trial investigators judge to be unsuitable for any other reason.
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.
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+13758469563
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
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Primary endpoints
Objective Response Rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.