Printed from Voxsanity (voxsanity.com.au) — NCT06616584 — 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, Recruiting
NCT06616584
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 been assigned to this sub-study (S1800E) through the main LUNG-MAP study protocol, as determined by the SWOG Statistics and Data Management Center.
- People who have measurable or non-measurable signs of disease confirmed by CT or MRI scan, with scans completed within the required timeframes before joining.
- People who have had a CT or MRI scan of the brain to check for cancer spread within 42 days before joining.
- People who have received exactly one prior immunotherapy treatment (a type called anti-PD-1 or anti-PD-L1) for advanced or recurrent lung cancer, either alone or combined with other treatments, under specific conditions about when the cancer progressed during or after that treatment.
- People whose cancer progressed more than 84 days after starting their most recent immunotherapy treatment.
- People who received immunotherapy for advanced or returned cancer and whose cancer at best held steady, partially shrank, or fully responded to that treatment.
- People who have previously received platinum-based chemotherapy and whose cancer progressed during or after it.
- People who have a known gene or molecular change in their cancer (such as EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2, or MET) must have already received at least one approved targeted therapy for that change.
- People who have recovered from most side effects of their most recent cancer treatment (side effects must be mild, grade 1 or lower) before joining.
- People whose blood test results fall within the required ranges for white blood cells, red blood cells, platelets, liver function, and kidney function, all tested within 28 days before joining.
- People who have had a urine protein test within 28 days before joining.
- People with a general health/activity level rated at 0 or 1 on the ECOG scale (meaning largely able to carry out normal daily activities), assessed within 28 days before joining.
- People with a completed medical history and physical examination within 28 days before joining.
- People with chronic hepatitis B who have an undetectable viral level while on suppressive treatment, based on results from within the past 6 months (if the treating doctor considers this relevant).
- People with a history of hepatitis C who have completed treatment and been cured, or who are currently being treated and have an undetectable viral level based on recent results within 6 months (if the treating doctor considers this relevant).
- People living with HIV, provided they are on effective HIV treatment and have had an undetectable viral level at their most recent test within the past 6 months.
- People who agree to have blood samples collected for a specific type of cancer DNA testing (circulating tumour DNA).
- People who agree to have additional tissue or fluid samples stored for future research.
- People who have been fully informed about the trial and have signed a consent form. If someone has difficulty making decisions independently, a legally authorised representative may sign on their behalf.
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 previously been treated with a chemotherapy drug called docetaxel for this cancer.
- People who have received palliative radiation therapy within the past 14 days, or palliative bone radiation within the past 7 days.
- People who are planning to receive other chemotherapy, immunotherapy, or biological cancer treatments at the same time as this trial.
- People who have had major surgery within 28 days before joining, or who have had complications such as bleeding or wound problems from surgery within the past 2 months, or who have planned major surgery scheduled during the trial period.
- People who have had a venous access device (a small device placed under the skin to help with intravenous treatment) placed within 7 days before joining.
- People whose liver function tests (bilirubin, AST, ALT) or kidney function fall outside the acceptable ranges, unless specific medical exceptions apply (such as a condition called Gilbert's disease, or a history of liver spread from cancer).
- People who have another cancer whose history or treatment could interfere with assessing the safety or effectiveness of this trial's treatment.
- People who have an active autoimmune disease that has required systemic treatment (medicines that affect the whole body's immune system) within the past 730 days (approximately 2 years). Hormone or gland replacement therapies are not considered systemic treatment and are allowed.
- People with a history of a primary immune system deficiency condition.
- People who experienced serious immune-related side effects from previous immunotherapy, including any grade 3 or worse reaction, any unresolved grade 2 reaction, or any reaction that caused them to permanently stop their immunotherapy. Exceptions may apply for certain manageable conditions requiring replacement therapy (confirm with trial site).
- People who have had an organ transplant requiring ongoing immunosuppressive medication.
- People who have received a live or live-attenuated vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, typhoid, or nasal spray flu vaccine) within 28 days before joining. Standard injected flu vaccines and COVID-19 vaccines are permitted.
- People who currently show signs or symptoms of active tuberculosis.
- People who have a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis or interstitial lung disease.
- People who have had a serious or unhealed wound, ulcer, or bone fracture within 28 days before joining.
- People who have had a bowel perforation (a hole in the gut) or abnormal connection (fistula) within the past 6 months.
- People who have had severe gastrointestinal bleeding within the past 3 months, or any gastrointestinal bleeding within the past 3 months.
- People with serious heart disease, unstable chest pain (angina), a heart attack within the past 6 months, or a serious uncontrolled irregular heartbeat.
- People who have had a blood clot in an artery (such as a stroke, mini-stroke, heart attack, or unstable angina) within the past 6 months.
- People who have coughed up a significant amount of bright red blood within the past 2 months, or whose scans show the cancer is invading major blood vessels or has formed a cavity within a tumour.
- People who have been diagnosed with a blood clot in a vein within the past 3 months. People diagnosed with a venous blood clot more than 3 months ago may be considered, provided they are on stable anticoagulant (blood-thinning) medication.
- People with significant liver scarring (cirrhosis) at a certain severity level, or with a history of liver-related confusion (hepatic encephalopathy) or significant fluid build-up in the abdomen related to cirrhosis, or any degree of cirrhosis (confirm with trial site).
- People who are pregnant or breastfeeding. People who could become pregnant or who could father a child must agree to use effective contraception during the 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
Principal Investigator: Saiama N Waqar, SWOG Cancer Research Network
Phone: 210-614-8808
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
Recruiting
Phase
Phase 3
Sponsor
SWOG Cancer Research Network
Registry
ClinicalTrials.gov
Start date
22 May 2025
Est. completion
31 December 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Overall survival (OS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 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.