Printed from Voxsanity (voxsanity.com.au) — NCT07382726 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Lung Cancer Trial, Recruiting
NCT07382726
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 must have a confirmed diagnosis of non-small cell lung cancer (NSCLC), either through a tissue sample or fluid sample test.
- People must have NSCLC that has spread to other parts of the body or is locally advanced and cannot be treated with the goal of a cure.
- The cancer must have a specific genetic change called a KRAS G12C mutation, which can be detected through tumour tissue or a blood test (confirm with trial site for testing options).
- People must have already received treatment with a KRAS G12C inhibitor (either alone or in combination with another therapy) and the cancer continued to grow or spread during that treatment.
- People must have received at least one, and no more than three, prior lines of cancer treatment.
- People must have measurable areas of cancer that can be tracked using standard imaging criteria (RECIST v1.1).
- People must be 18 years of age or older, as there is currently no safety data available for those under 18.
- People must have a good general level of physical functioning, rated 0 or 1 on the ECOG scale, meaning they are fully active or able to carry out light activity (confirm with trial site).
- The most recent systemic cancer treatment (such as chemotherapy, immunotherapy, or an experimental treatment) must have been stopped at least 2 weeks before the first dose of study treatment.
- The most recent radiation treatment (including to the brain) must have been stopped at least 1 week before the first dose of study treatment.
- People must have blood counts and organ function within acceptable ranges, including adequate levels of red blood cells, white blood cells, platelets, liver enzymes, and kidney function (confirm specific values with trial site).
- People with a chronic hepatitis B infection must have an undetectable level of the virus in their blood.
- People with a history of hepatitis C infection must have documentation showing the virus is undetectable in their blood.
- People who have had brain metastases that have already been treated may be eligible, as long as their neurological condition has been stable for at least 1 week before the first dose, and they are either not taking corticosteroids or are on a stable or reducing low dose (confirm with trial site).
- People who have had or currently have another type of cancer may be eligible, as long as that cancer or its treatment is unlikely to interfere with the safety or results of this trial.
- People with a known history of heart disease or past treatment with heart-affecting therapies must have a heart function assessment, and must be rated at class 2B or better on the New York Heart Association scale (confirm with trial site).
- Women who could become pregnant and men must agree to use reliable contraception before, during, and for a set period after completing study treatment (7 months for women who could become pregnant, 4 months for men), unless specific criteria confirming they cannot become pregnant apply (confirm acceptable methods and full requirements with trial site).
- Men enrolled in the trial must also agree to use adequate contraception before, during, and for 4 months after completing study treatment.
- People must be willing and able to understand and sign a written informed consent form.
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 not fully recovered from side effects of previous cancer treatments, where those side effects are still at a moderate or higher level (above Grade 1), except for hair loss or where other eligibility criteria already cover that issue.
- People who are currently taking part in another clinical trial involving an experimental treatment.
- People who have brain metastases that have not yet been treated, or cancer that has spread to the lining around the brain or spinal cord.
- People who have had a significant allergic reaction to drugs that are chemically or biologically similar to the study treatments (adagrasib or iza-bren).
- People who have a prior history of lung inflammation (pneumonitis) or scarring of the lung tissue (interstitial lung disease), except for those whose radiation-related lung inflammation had no symptoms or resolved with steroid treatment and is no longer active.
- People living with HIV, except for those on effective HIV treatment with an undetectable viral load in the past 6 months, who may be eligible (confirm with trial site).
- People with mental health conditions or personal circumstances that would make it difficult to follow the requirements of the study.
- People who are currently pregnant or breastfeeding.
- People who have had major surgery within 4 weeks before the first dose of study treatment.
- People who have a history of bowel disease or major stomach surgery that could affect how the study drugs are absorbed, or who are unable to swallow oral medications.
- People with a prolonged heart electrical interval (QTc) on an ECG — over 470 milliseconds for women or over 450 milliseconds for men — or a personal or close family history of a condition called congenital Long QT Syndrome.
- People who have had a stroke or a temporary stroke-like episode (transient ischemic attack) within the 6 months before the first dose of study treatment.
- People who have had unstable chest pain (angina), a heart attack, or symptomatic irregular heart rhythm (atrial fibrillation) within the 6 months before the first dose of study treatment.
- People with any serious or uncontrolled illness, active infection, or other medical condition that, in the opinion of the study doctor, would likely interfere with their participation in the trial or the interpretation of the results.
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.
Contact this trial
Principal Investigator: Marcelo V Negrao, MD, M.D. Anderson Cancer Center
Phone: 713-745-7943
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Recruiting
Phase
Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
24 December 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Safety and Adverse Events (AEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 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.