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Phase 3 Lung Cancer Trial, By Invitation
NCT04762459
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 or older, of any gender.
- People who have been diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC), confirmed by laboratory testing of tissue, that is mainly of a non-squamous type.
- People who had a brain scan done before their lung surgery, as part of standard care.
- People whose lung cancer has been classified as Stage II or Stage IIIA based on examination of tissue removed during surgery.
- People whose tumour has been confirmed by a central laboratory to carry one of two specific gene changes (called EGFR mutations — either Ex19del or L858R), which may be present alone or alongside other EGFR mutations including T790M.
- People who are able to provide tumour tissue samples (either paraffin-embedded sections of 10–15 sheets, wax blocks, or fresh frozen tissue).
- People who have had complete surgical removal of their lung cancer, with no visible cancer remaining and all surgical edges clear of cancer cells.
- People with a World Health Organization Performance Status of 0 or 1, meaning they are fully active or have only minor restrictions in physically strenuous activity (confirm with trial site).
- Women of childbearing potential who test negative for pregnancy before starting treatment and who agree to use appropriate contraception from the screening period until 3 months after stopping the study treatment, and who are not breastfeeding.
- Male participants who agree to use barrier contraception (such as condoms) from the screening period until 3 months after stopping the study treatment.
- People who are willing and able to provide written informed consent to participate.
- People who are enrolled within 10 weeks of their surgery.
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 received, or are planned to receive, radiation therapy for their current lung cancer before or after surgery.
- People who have received chemotherapy (including platinum-based chemotherapy) before surgery (as neoadjuvant treatment).
- People who have previously received any EGFR-targeted therapy (called EGFR-TKI) at any time, whether before or after surgery.
- People who have received any other anti-tumour treatment for lung cancer, including certain traditional Chinese medicines with anti-tumour effects or immunotherapy.
- People who have had major surgery (not including placement of a vascular access line) within 4 weeks before the first dose of the study drug.
- People who have taken another experimental drug within a specific timeframe related to how long that drug stays in the body (confirm with trial site).
- People who have taken certain medications that strongly affect a liver enzyme called CYP3A4 within 7 days before the first dose of the study drug (confirm with trial site).
- People whose lung surgery involved only small, limited procedures such as segmentectomy or wedge resection, rather than more complete removal.
- People with a history of another cancer, unless it was adequately treated non-melanoma skin cancer, a fully treated in-situ cancer, or another solid cancer that was fully treated with no signs of return for more than 5 years.
- People who still have unresolved side effects from previous treatments rated above a mild level (Grade 1), with the exception of hair loss or moderate nerve-related side effects from prior platinum chemotherapy.
- People with serious or uncontrolled health conditions, including uncontrolled high blood pressure, active abnormal bleeding, or active infections such as hepatitis B, hepatitis C, or HIV.
- People with ongoing severe nausea and vomiting, chronic gut conditions, an inability to swallow tablets, or who have had significant bowel surgery that could affect how the body absorbs the study drug.
- People with certain heart-related issues, including:
- A specific heart rhythm measurement (QTc interval) greater than 470 milliseconds on three separate heart trace (ECG) readings.
- Significant abnormalities in heart rhythm or electrical conduction seen on a resting ECG (confirm with trial site for specific examples).
- Conditions or factors that increase the risk of heart rhythm problems, such as heart failure, low potassium levels, a personal or family history of long QT syndrome, unexplained sudden death in a close family member under age 40, or taking medications known to affect heart rhythm.
- People with a history of a lung condition called interstitial lung disease (ILD), lung inflammation caused by drugs or radiation that required steroid treatment, or any currently active ILD.
- People with insufficient bone marrow function or poor organ function (confirm with trial site).
- People with a known allergy or sensitivity to the study drug Almonertinib or to drugs with a similar structure.
- People who are allergic to pemetrexed, cisplatin, or other platinum-containing compounds, or to any ingredients in those preparations.
- People for whom pemetrexed or cisplatin are medically unsuitable (confirm with trial site).
- People with severe and uncontrolled eye disease that an eye specialist considers a specific safety risk.
- People who, in the opinion of the study doctor, are unlikely to follow the study procedures and requirements.
- People with any condition that, in the study doctor's opinion, could affect their safety or interfere with the study.
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
By Invitation
Phase
Phase 3
Sponsor
Chinese Academy of Medical Sciences
Registry
ClinicalTrials.gov
Start date
1 August 2021
Est. completion
1 May 2026
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
🇨🇳 China
Primary endpoints
Disease free survival (DFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 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.