Printed from Voxsanity (voxsanity.com.au) — NCT07410611 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Lung Cancer Trial, Not Yet Recruiting
NCT07410611
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 between 18 and 75 years of age at the time of signing the consent form, both men and women are eligible.
- People with a confirmed diagnosis of a specific type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to a limited number of places in the body — no more than 3 organs and no more than 5 spread sites in total — and has not yet been treated.
- People whose lung cancer has a specific genetic change (mutation) in a gene called EGFR, specifically the type known as 19Del or 21L858R.
- People who have at least one tumour that can be measured on a scan, according to standard measurement guidelines.
- People who are generally well enough to carry out everyday activities with no or minimal limitations (assessed using a standard medical scale called ECOG 0–1).
- People who are expected to live for at least 12 weeks.
- People who have not received any previous systemic treatment (such as chemotherapy, targeted therapy, immunotherapy, or experimental drugs) for advanced lung cancer — though people who previously received early-stage treatments such as adjuvant or neoadjuvant therapy may still be eligible if their cancer did not return within 6 months of finishing that treatment.
- People whose blood counts and organ function meet specific laboratory thresholds, including: red blood cell levels, white blood cell levels, and platelet counts within acceptable ranges; liver enzyme and function tests within acceptable ranges (with slightly higher limits allowed if cancer has spread to the liver); kidney function within acceptable ranges; and normal blood clotting test results — all measured without the need for recent transfusions or medical corrections.
- Women who could become pregnant must agree to use effective contraception during the study and for 6 months after it ends, must have a negative pregnancy test within 7 days before joining, and must not be breastfeeding; male participants must also agree to use contraception during the study and for 6 months afterward.
- People who are willing to take part voluntarily, sign a written consent form, follow study requirements, and provide blood samples.
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 whose lung cancer is small cell lung cancer, or a mixed type that includes small cell lung cancer or neuroendocrine carcinoma.
- People whose lung cancer has a specific type of EGFR mutation that is different from those required — such as exon 20 insertion, L861Q, G719X, or S768I mutations.
- People who have already received systemic treatment for advanced or metastatic lung cancer, such as chemotherapy, targeted therapy, immunotherapy, or biological therapy.
- People who currently have brain metastases causing symptoms, cancer spreading to the lining of the brain or spinal cord, or signs of these conditions on a recent scan — except for people whose previously treated brain metastases have been stable for at least 4 weeks with no signs of bleeding in the brain.
- People with a known allergy or sensitivity to the study drug (Befotertinib) or to similar drugs.
- People who have difficulty absorbing oral medications due to conditions such as an inability to swallow, ongoing severe diarrhoea, or a bowel obstruction.
- People who have a history of inflammatory lung disease (interstitial lung disease), lung damage from previous drugs, or radiation-related lung inflammation that required steroid treatment.
- People with serious uncontrolled health conditions such as uncontrolled high blood pressure, uncontrolled diabetes, active bleeding, or active infections including uncontrolled hepatitis B, hepatitis C, or HIV.
- People with a specific heart rhythm abnormality called QTc prolongation (greater than 470 ms on a heart tracing) or any other clinically significant heart rhythm problem.
- People who, in the judgement of the trial doctor, have any other condition that would make participation in this study unsuitable or unsafe (confirm with trial site).
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
Phone: 0086-0311-86095628
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
Not Yet Recruiting
Phase
Phase 2
Sponsor
Hebei Medical University Fourth Hospital
Registry
ClinicalTrials.gov
Start date
10 February 2026
Est. completion
28 February 2030
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression-Free Survival; PFS
Can't join this trial?
Data last synced from ClinicalTrials.gov: 10 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.