Printed from Voxsanity (voxsanity.com.au) — NCT06015568 — 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, Not Yet Recruiting
NCT06015568
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.
- People with a laboratory-confirmed diagnosis of advanced or spreading non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation, and whose cancer has a specific genetic change called an EGFR exon 19 deletion or exon 21 L858R mutation (alone or alongside other EGFR mutations), confirmed by genetic testing.
- For Part 1 of the trial: people with advanced NSCLC whose cancer has gotten worse on standard treatment, who could not tolerate standard treatment, or who declined standard treatment (and people previously treated with a drug called Befotertinib must have had their cancer progress on that drug).
- For Part 2, Cohort A: people with advanced NSCLC who have the EGFR-sensitive mutation and have not yet received any systemic (whole-body) anti-cancer treatment for their advanced or spreading cancer.
- For Part 2, Cohort B: people with advanced NSCLC who have the EGFR-sensitive mutation and whose cancer has stopped responding to a third-generation EGFR-targeted drug.
- For Part 2, Cohort C: people with advanced NSCLC who have the EGFR-sensitive mutation and whose cancer has stopped responding to a first- or second-generation EGFR-targeted drug.
- People in Cohorts B and C must also have had their cancer stop responding to, be unable to tolerate, or have declined platinum-based chemotherapy.
- People in the dose-finding stage of Part 1 must have detectable disease, while all others must have measurable disease according to standard criteria (RECIST v1.1).
- The cancer lesions being measured must either have had no prior local treatment, or must have clearly grown again within a previously treated area, as determined by standard criteria.
- People with a general health and activity level rated as 0 or 1 on the ECOG scale (meaning largely able to carry out normal daily activities).
- People with an expected survival of at least 3 months.
- People whose blood and organ function meet required levels — including healthy enough numbers for white blood cells, platelets, haemoglobin, albumin, liver enzymes, bilirubin, and kidney function — without needing transfusions or certain medical supports in the 14 days before testing (confirm specific values with trial site).
- People who are willing and able to follow the trial schedule and all follow-up visits.
- People who understand the nature of the trial and are willing to sign a written consent form voluntarily.
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 taken certain experimental or anti-cancer drugs within the past 14 days or 5 half-lives of that drug (whichever is longer), with specific time limits applying to some drug types (confirm with trial site).
- People who have had major surgery or radiation therapy within 4 weeks before starting the trial (limited localised palliative radiation given at least 2 weeks before starting may be acceptable).
- For Part 2 and the dose expansion stage: people who have already received more than three lines of systemic anti-cancer treatment (not counting maintenance therapy).
- People who have previously been treated with a type of drug that targets both EGFR and c-Met at the same time (examples include JNJ-61186372, EMB-01, or GB263T).
- People who still have side effects from previous cancer treatment that have not reduced to a mild level or resolved, except for hair loss.
- People who have had another cancer in the past 3 years, except for certain cancers considered fully or locally cured (such as some skin cancers, early-stage cervical cancer, or early-stage breast cancer in situ).
- People with a primary brain tumour, cancer that has spread to the membranes around the brain, brain metastases pressing on the spinal cord, risk of bleeding in the brain, brain metastases causing symptoms, or brain metastases that required steroids or medication to reduce brain pressure within the 2 weeks before enrolment (people with brain metastases that are stable and symptom-free for more than 2 weeks after treatment and do not need steroids or pressure-reducing medication may still be considered).
- People with clinically significant heart or blood vessel problems, including:
- A blood clot in an artery, deep vein, or lung diagnosed within the 3 months before starting the trial (some minor clots may not apply — confirm with trial site).
- A heart attack, unstable chest pain, stroke, mini-stroke, bypass surgery, or any acute heart event within the past 6 months.
- An abnormal heart rhythm measurement (QTcF) on an ECG at rest that is 450 milliseconds or above for men, or 470 milliseconds or above for women, or other significant heart rhythm or electrical problems.
- Poorly controlled high blood pressure (systolic above 180 mmHg or diastolic above 100 mmHg) in the opinion of the doctor running the trial.
- Moderate to severe heart failure (New York Heart Association Grade III–IV), or a hospital admission for heart failure in the past 6 months.
- Inflammation of the sac around the heart or significant fluid around the heart.
- Disease of the heart muscle (cardiomyopathy).
- Any other significant heart or blood vessel condition considered clinically important by the treating doctor.
- People with active hepatitis B, hepatitis C, HIV, or syphilis infections (people with a past hepatitis C infection who have completed antiviral treatment and have undetectable virus levels, or those who test negative for active syphilis, may still be considered — confirm with trial site).
- People with lung scarring or inflammation (interstitial lung disease), including that caused by drugs or radiation, who have needed long-term steroids or immune-suppressing medication in the past year.
- People with active gut or digestive diseases that could seriously affect how the trial drug is absorbed or processed, or who are at risk of a hole forming in the gut — including people unable to swallow tablets, those with uncontrolled nausea or vomiting, bowel blockage, inflammatory bowel disease, or extensive bowel removal (confirm with trial site).
- People with a serious current illness or medical condition, including uncontrolled active infection, uncontrolled fluid build-up around the lungs or abdomen, or significant lung, metabolic, or psychiatric conditions.
- Women of childbearing age who test positive for pregnancy within 7 days before starting treatment, women who are pregnant or breastfeeding, and men or women who are not willing to use effective contraception — or who plan to conceive — during treatment and for 3 months after treatment ends.
- People who have a known or suspected allergy to the study drugs MCLA-129 or Befotertinib, or to any of their ingredients.
- People who are currently taking, or would need to take during the study, strong drugs that significantly affect how the body processes a liver enzyme called CYP3A, within one week before starting the trial (confirm with trial site).
- People who are still using the blood-thinning drug Warfarin within 7 days before starting the trial (certain other blood thinners may be allowed — confirm with trial site).
- People who are unlikely to follow the study requirements, unwilling to attend follow-up visits, or who are considered unsuitable for the trial in the opinion of the treating doctor.
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.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Betta Pharmaceuticals Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 September 2023
Est. completion
4 November 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Dose-Limiting Toxicity (DLT); Maximum Tolerable Dose (MTD); Treatment-Emergent Adverse Event (TEAE) in Part 1; Overall Response Rate (ORR) in Part 2
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 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.