Phase 2 Lung Cancer Trial, 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, understand what the study involves, and are able to sign a consent form.
- People who have been diagnosed with extensive-stage small cell lung cancer (a type of lung cancer that has spread), a cancer type called neuroendocrine carcinoma, or other tumours that test positive for a protein called DLL3 — and whose cancer has come back or worsened after standard treatments, including certain chemotherapy and, in most cases, immunotherapy. No more than 2 previous chemotherapy treatments and no more than 3 total treatments for advanced or spread disease are allowed.
- People who are able to provide blood or tumour tissue samples for testing as part of the study.
- People who have at least one tumour that can be measured on a scan, according to standard measurement guidelines.
- People whose general health and ability to carry out daily activities is rated as fully active or restricted in physically strenuous activity only (scored 0 or 1 on a standard medical scale).
- People who are expected to live for more than 3 months.
- People whose bone marrow, liver, kidneys, and other organs are functioning well enough to meet the study's requirements.
- Women who could become pregnant must agree to use highly effective contraception from signing the consent form until 8 months after the last dose of the study drug. Men whose partners could become pregnant must use effective contraception until 5 months 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 whose lung cancer is a mixed type combining small cell and non-small cell lung cancer (though small cell lung cancer with a specific subtype called large cell neuroendocrine carcinoma is still eligible).
- People who have cancer that has spread to the brain or spinal cord and has not yet been treated with radiation or surgery, or where that spread is currently active.
- People who have had another type of cancer within the past 2 years — though some exceptions may apply (such as certain skin cancers, early-stage cancers that were fully treated, or certain thyroid or prostate cancers with no signs of return). Other cases may be reviewed individually by the medical team overseeing the trial.
- People whose cancer is causing pain that cannot be adequately controlled.
- People with serious heart or blood vessel disease.
- People who have had a significant bleeding episode within the 3 months before joining the trial.
- People with a history of lung inflammation (pneumonitis) from previous treatment, current non-infectious lung inflammation being treated with steroids, signs of lung scarring seen on recent scans, or other moderate to severe lung conditions affecting breathing in the 3 months before joining — including conditions such as pulmonary fibrosis or organising pneumonia.
- People with a weakened immune system or who test positive for HIV.
- People with known or suspected hepatitis B or hepatitis C infection.
- People who have had active tuberculosis within the past year.
- People joining the part of the trial that includes the drug durvalumab, who have previously had a moderate or severe immune-related side effect from immunotherapy (grade 2 or higher heart inflammation, or grade 3 or higher immune reaction), unless it has fully or nearly fully resolved.
- People joining the part of the trial that includes the drug IDE161, who have previously had their stomach or part of their upper bowel removed, or who have a condition affecting how the bowel absorbs medication — such as Crohn's disease or ulcerative colitis.
- People who have recently received certain other cancer treatments — including chemotherapy within the past 3 weeks, immunotherapy or biological treatments within the past 2 weeks, certain other targeted treatments within the past 2 weeks or within a specific timeframe based on how long the drug stays in the body, or other experimental treatments within the past 4 weeks (or longer, depending on the drug).
- People currently taking certain medications that strongly affect how the body processes drugs, including strong inhibitors or activators of liver enzymes called CYP3A4 or CYP2D6, or drugs affecting certain drug transporters called P-gp or BCRP. People joining the IDE161 part of the trial also cannot take certain stomach acid medications (such as proton pump inhibitors, H2 blockers, or antacids) or drugs that interact with specific drug transporters (confirm details with trial site).
- People who have been previously treated with a drug that targets DLL3 in a similar way (called a DLL3 ADC), or who have previously received a type of chemotherapy called a topoisomerase I inhibitor (including as part of a similar targeted drug).
- People joining the durvalumab part of the trial who previously had serious intolerance to immunotherapy drugs that target PD-1 or PD-L1.
- People who have received high-dose chest radiation (more than 30 Gy) within the past 12 weeks, or high-dose radiation to other parts of the body (more than 30 Gy) within the past 4 weeks. Some exceptions apply for brain radiation or lower-dose palliative radiation completed more than 14 days before starting the trial (confirm details with trial site).
- People who have had major surgery or a serious physical injury within the 4 weeks before starting the trial.
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within 8 months of the last dose of the study drug.
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Part 1A: Safety and Tolerability of IDE849 (Monotherapy); Part 1B: Safety and Tolerability of IDE849 in Combination with durvalumab or IDE161; Part 2: Safety and Tolerability of IDE849 (Monotherapy Dose Expansion); 4. Part 2: Safety and Tolerability of IDE849 in Combination with durvalumab or IDE161 (Dose Expansion); Part 2: Objective Response Rate (ORR) and Investigator Assessment of IDE849 ORR per RECIST 1.1; Part 2: Duration of Response (DOR) and Investigator Assessment of IDE849 DOR per RECIST 1.1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.