Printed from Voxsanity (voxsanity.com.au) — NCT06885840 — 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
NCT06885840
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 aged 18 or older, of any gender.
- People who have been diagnosed with advanced non-small cell lung cancer (a type of lung cancer) that cannot be removed by surgery or has spread to other parts of the body, confirmed by a tissue or cell sample.
- People whose cancer has gotten worse or who could not tolerate standard treatments, and who fall into one of four groups based on specific genetic features of their cancer and prior treatments received (confirm with trial site for which group applies).
- People in Group 1 or Group 2: those whose lung cancer has a specific gene change called an EGFR mutation (either exon 19 deletion or exon 21 L858R), whose cancer progressed after earlier targeted treatments, following one of two specific treatment pathways (confirm with trial site).
- People in Group 1 specifically: those whose cancer has a gene change called MET amplification after stopping responding to EGFR-targeted treatments.
- People in Group 2 specifically: those whose cancer got worse or who could not tolerate MET inhibitor treatments, but who had some benefit from those treatments.
- People in Group 3 or Group 4: those whose lung cancer has a different type of actionable gene change, whose cancer progressed after receiving the matching targeted treatment and platinum-based chemotherapy.
- People in Group 3 specifically: those whose cancer has MET amplification after stopping responding to the targeted treatment matched to their gene change.
- People in Group 4 specifically: those whose cancer got worse or who could not tolerate MET inhibitor treatments, but who had some benefit from those treatments.
- People who have at least one measurable area of cancer that meets specific measurement standards (RECIST v1.1), either in an area that has not had prior local treatment or radiation, or in an area where the cancer has clearly grown back after such treatment.
- People who are generally well enough to carry out daily activities with little to no limitation, based on a standard medical scale scoring 0 or 1.
- People with an expected survival of at least 3 months.
- People whose blood and organ function tests meet all of the following levels (without the need for blood transfusions or certain medication support in the 14 days before testing): a healthy enough number of white blood cells (neutrophils at least 1.5×10⁹/L); a healthy enough platelet count (at least 75×10⁹/L); a healthy enough haemoglobin level (at least 100 g/L); a healthy enough blood protein (albumin) level (at least 30 g/L); liver function within acceptable ranges (bilirubin no more than 1.5 times the normal upper limit; liver enzymes ALT and AST no more than 3 times the normal upper limit); and kidney function within acceptable ranges (creatinine no more than 1.5 times the normal upper limit, or if slightly above that, kidney clearance rate of at least 50 mL/min confirmed by specific testing).
- People who are willing and able to follow all trial procedures and attend follow-up appointments.
- People who understand what the trial involves and are willing to sign a consent form.
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 another experimental treatment or anti-cancer drug (including certain traditional Chinese medicine anti-cancer treatments) within 14 days before the first trial dose, or within 5 half-lives of that drug — whichever is longer (with specific time limits for certain drugs, confirm with trial site).
- People who have had major surgery or radiotherapy within 4 weeks before the first trial dose (localised palliative radiotherapy is allowed if it was given at least 2 weeks before the first dose).
- People who have already received more than four lines of systemic anti-cancer treatment (not counting maintenance therapy).
- People who have previously been treated with certain specific EGFR/c-Met bispecific antibody or antibody-drug treatments, including Amivantamab, EMB-01, GB263T, PM1080/HS-20117, TAVO412, YH013/DM005, AZD9592, or SHR-9839.
- People who still have side effects from previous cancer treatments that have not reduced to a mild level (Grade 1 or below on a standard scale), except for hair loss.
- People who have had another type of cancer in the past 3 years, unless it was completely cured or treated locally, such as certain skin cancers, cervical cancer in situ, or breast cancer in situ.
- People whose cancer started in the brain, has spread to the lining of the brain, or who have brain metastases causing symptoms or that have not yet been treated — though people with previously treated, stable, symptom-free brain metastases who do not need steroids or other medications to manage brain swelling, and have no risk of brain bleeding, may still be considered (confirm with trial site).
- People with clinically significant heart or blood vessel disease.
- People diagnosed with a blood clot in an artery, deep vein, or lung within 3 months before the first trial dose (certain minor or unrelated clots may not apply; people with a clot history older than 3 months must have been stable for at least 4 weeks, confirm with trial site).
- People who have had a heart attack, unstable chest pain, stroke, mini-stroke, bypass surgery, or any acute coronary event within 6 months before the first trial dose.
- People with an abnormal heart rhythm reading (QTcF interval) on a resting ECG at screening — specifically, an average reading of 450 milliseconds or more for men or 470 milliseconds or more for women across three ECG measurements — or people with other significant heart rhythm or electrical conduction problems identified on a resting ECG.
- People with poorly controlled high blood pressure (systolic above 180 mmHg or diastolic above 100 mmHg) in the opinion of the treating doctor.
- People with severe heart failure (New York Heart Association Grade III or IV), or who were hospitalised due to heart failure within 6 months before the first trial dose.
- People with inflammation of the lining around the heart or a clinically significant fluid build-up around the heart.
- People with a disease affecting the heart muscle (cardiomyopathy).
- People with other significant heart-related conditions as determined by the treating doctor.
- People with active hepatitis B (with specific blood marker levels above set thresholds), or who test positive for hepatitis C antibodies, HIV antibodies, or syphilis antibodies.
- People who have a history of scarring or inflammation in the lung tissue (interstitial lung disease), or who currently show signs of it, including from prior drug treatment or radiation.
- People with serious ongoing illness or medical conditions, including but not limited to uncontrolled active infection, uncontrolled fluid build-up around the lungs or abdomen, or significant lung, metabolic, or mental health conditions.
- Women who could become pregnant and have a positive pregnancy test within 7 days before starting treatment, women who are pregnant or breastfeeding, or any participant (male or female) who is unwilling to use effective contraception throughout the trial and for 3 months after treatment ends, or who plans to have a child during that time.
- People with known allergic or hypersensitivity reactions to the trial drug (MCLA-129) or any of its ingredients.
- People who are unlikely to follow the study procedures or attend follow-up as required, or who the treating doctor considers unsuitable for participation for any other reason.
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.
Contact this trial
Phone: 18258270120
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
Betta Pharmaceuticals Co., Ltd.
Registry
ClinicalTrials.gov
Start date
31 March 2025
Est. completion
1 April 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Overall Response Rate (ORR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 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.