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Phase 3 Lung Cancer Trial, Recruiting
NCT04181060
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 confirmed by a laboratory to have a type of lung cancer called non-squamous, non-small cell lung cancer (NSCLC).
- People whose cancer is at an advanced stage — either stage IV, stage IIIB that cannot be treated with combined therapies, or cancer that has come back after earlier treatment for stage I–III disease.
- People whose cancer has a specific genetic change (mutation) in a gene called EGFR — for example, an Exon 19 deletion or L858R mutation, among others. Note: a specific type called EGFR exon 20 insertion does not meet this criterion.
- People who have not previously been treated with a type of drug called an anti-VEGF agent.
- People who have not previously received systemic (whole-body) treatment for metastatic disease.
- People who have previously had radiation therapy, provided limited radiation was completed at least one week before starting the study drug, and whole-brain radiation was completed at least two weeks before starting.
- People aged 18 or older.
- People whose general physical functioning falls within a standard medical rating scale of 0 to 2 (meaning able to carry out daily activities with mild to moderate limitation at most) (confirm with trial site).
- People whose recent blood test results (taken within 14 days before joining) show that blood cell counts, kidney function, and liver function are within acceptable ranges set by the trial.
- People living with HIV who are on effective treatment and have had an undetectable viral load within the last 6 months.
- People with chronic hepatitis B who are on suppressive therapy and have an undetectable viral load.
- People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load.
- People who have had brain metastases (cancer that has spread to the brain) that have been treated, provided the brain is neurologically stable and no steroid medication is needed, and the lesions are not bleeding.
- People with untreated brain metastases, if the treating doctor determines that immediate brain-specific treatment is not required and the lesions are stable and not bleeding.
- People who have or have had another cancer, if that cancer or its treatment is unlikely to interfere with this trial's safety or results.
- People with a known history of heart disease, provided a medical assessment places their heart function at a certain level of stability (confirm with trial site).
- People who are able to understand the study and are willing to sign a consent form and follow the study requirements.
- People who have not taken any experimental drug within either five half-lives of that drug or 3 months before starting the study (whichever is the longer period).
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 with the specific EGFR mutation type called exon 20 insertion.
- People who have previously been treated with a type of targeted drug called an EGFR TKI — with one specific exception: people who started a drug called osimertinib within 21 days before the planned randomisation date, under certain conditions (confirm with trial site).
- People who have risk factors related to the anti-VEGF drug, including coughing up blood, active heart or blood vessel disease, uncontrolled high blood pressure, significant amounts of protein in the urine, or a tumour that is growing into major blood vessels.
- People who are pregnant or breastfeeding.
- People of childbearing potential who are not willing or able to use effective contraception for the required periods during and after treatment (specific timeframes depend on the treatment arm assigned).
- People currently taking, or unable to stop taking, certain medications or herbal supplements that strongly affect how the body processes a specific drug pathway (known as strong CYP3A4 inducers) before starting treatment.
- People with unresolved side effects from previous treatments that are above a mild level, with the exception of hair loss or certain nerve-related symptoms from prior platinum chemotherapy.
- People with severe or uncontrolled health conditions, including uncontrolled high blood pressure or active abnormal bleeding.
- People who have ongoing nausea or vomiting, chronic digestive diseases, an inability to swallow tablets, or who have had significant bowel surgery that could affect how the study drug is absorbed.
- People with a history of a lung condition called interstitial lung disease, drug-related interstitial lung disease, or radiation-related lung inflammation that required steroid treatment.
- People with a known allergy or sensitivity to osimertinib or similar drugs.
- People whose heart's electrical activity (measured by ECG) shows a specific timing interval (QTc) above 470 milliseconds.
- People with significant abnormalities in their heart's electrical rhythm or conduction identified on a resting ECG.
- People with conditions or factors that increase the risk of heart rhythm problems, including certain electrolyte imbalances, heart failure, a hereditary heart condition called long QT syndrome, a family history of long QT syndrome, unexplained sudden death in a close relative under age 40, or current use of medications known to affect heart rhythm in a specific way.
- People who have received another investigational drug too recently (within five half-lives of that drug or 3 months, whichever is longer).
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
28 December 2020
Est. completion
31 December 2026
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Progression-free survival (PFS)
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.