Phase 3 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
- Adults aged 18 years or older (male or female).
- People diagnosed with a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that is locally advanced and not suitable for definitive treatment, has come back, or has spread to other parts of the body (Stage IV), confirmed by laboratory testing of tissue or cells.
- People whose lung cancer has a specific genetic change called an EGFR exon 20 insertion mutation, confirmed by an approved laboratory.
- The EGFR exon 20 insertion mutation may appear on its own or alongside certain other genetic changes, but not alongside specific EGFR mutations for which other approved targeted treatments already exist (such as exon 19 deletion, L858R, T790M, L861Q, G719X, or S768I) (confirm with trial site).
- Enough tumour tissue available — from either the original tumour or a secondary site — for a central laboratory to confirm the EGFR exon 20 insertion mutation.
- At least one area of cancer that can be measured using standard imaging criteria (RECIST Version 1.1).
- A life expectancy of at least 3 months.
- A general health and activity level rated 0 or 1 on a standard medical scale (ECOG), meaning the person is fully active or has only minor restrictions on physically demanding activity.
- Adequate organ and blood function, as assessed through blood tests, with any recent blood transfusions having occurred at least 14 days before testing (confirm with trial site).
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 already received systemic treatment for locally advanced or metastatic disease, including medications delivered directly into body cavities such as the chest (with some exceptions noted below).
- People whose prior chemotherapy or immunotherapy for early-stage (Stage I–III) disease, or combined chemotherapy and radiation for locally advanced disease, was completed less than 6 months before the cancer spread to become metastatic.
- People who received radiotherapy within 14 days before joining the trial, or who have not yet recovered from side effects of radiotherapy.
- People who have taken certain medications that strongly affect how the body processes drugs (moderate or strong CYP3A inhibitors or inducers) within 10 days before the first dose of the trial drug YK-029A.
- People whose cancer has certain other specific EGFR genetic changes at the same time, including exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
- People who have been diagnosed with another separate cancer in addition to their lung cancer.
- People who currently have cancer pressing on the spinal cord or cancer that has spread to the membranes surrounding the brain or spinal cord.
- People with high blood pressure that is not currently being controlled with treatment.
- People who received a live vaccine within 4 weeks before joining the trial.
- People who, in the judgement of the treating doctor, have severe or uncontrolled serious health conditions, including uncontrolled high blood pressure or active bleeding disorders such as haemophilia or Von Willebrand disease.
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.
Contact this trial
Principal Investigator: Hui Zhao, Doctor, Puhe Biopharma
Phone: +8618911018556
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.
Where this trial is recruiting
Primary endpoints
Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 .
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.