Printed from Voxsanity (voxsanity.com.au) — NCT07627321 — 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
NCT07627321
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 who give voluntary written consent before any study procedures begin and are willing to follow all study requirements.
- Men or women aged between 18 and 75 years (inclusive) at the time of signing the consent form.
- People with a laboratory-confirmed diagnosis of Stage IV (M1a, M1b, or M1c) squamous or non-squamous non-small cell lung cancer (NSCLC), based on tissue or cell samples.
- People who have not previously received systemic treatment for advanced or metastatic disease, or who received chemotherapy before or after surgery and whose cancer returned at least 6 months after their last dose of that treatment.
- People who have at least one measurable area of cancer (outside the original tumour site) that can be accurately measured repeatedly, and that has not previously been treated with radiation or other local therapies.
- People with a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are either fully active or have only minor restrictions on physically demanding activity (confirm with trial site).
- People whose cancer does not have known targetable gene changes (such as EGFR, ALK, or ROS1 mutations), with test results provided for all three; if no prior results exist, a new tissue sample or archived tissue must be tested before joining.
- People whose cancer cells show an EGFR protein expression level of 2+ or higher, confirmed by a specific laboratory staining test (IHC).
- People who are medically well enough to tolerate radiotherapy and who are expected to survive for at least 12 weeks.
- People who have never previously been treated with a type of drug known as an Antibody-Drug Conjugate (ADC).
- People whose blood test results, taken within 14 days before starting treatment, show that their blood counts, liver function, kidney function, and blood clotting are within acceptable ranges as defined by the trial (without having received blood transfusions, certain blood-boosting injections, or albumin infusions in the 14 days before those tests).
- Women who could become pregnant must have a negative pregnancy test (urine or blood) within 7 days before the first dose.
- Women who could become pregnant and are sexually active with male partners who have not been sterilised must agree to use highly effective contraception from the screening period until 180 days after the last dose.
- Men who have not been sterilised and are sexually active with women who could become pregnant must agree to use effective contraception from the screening period until 180 days after the last dose, and discuss any plans beyond that timeframe with the trial doctor.
- People who are willing and able to attend scheduled visits, follow the treatment plan, and complete all required tests and study activities.
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 previously received any systemic anti-cancer treatment for advanced, recurrent, or metastatic NSCLC, or who completed perioperative (before or after surgery) therapy less than 6 months before joining.
- People who have had another type of cancer within the past 5 years, not including fully cured skin basal cell carcinoma or cervical carcinoma in situ.
- People with a known allergy or sensitivity to the study drugs (Becotatug vedotin or Pucotenlimab) or any of their ingredients.
- People who have previously been treated with ADCs, PD-1/PD-L1 inhibitors, CTLA-4 inhibitors, or bispecific antibodies that target the immune system's checkpoint pathways.
- People with a history of serious bleeding problems or clotting disorders; significant bleeding episodes within the past month (such as gastrointestinal bleeding or coughing up a teaspoon or more of fresh blood); certain types of nosebleeds; or scan results showing the tumour is wrapping around major blood vessels or has features that the doctor considers high risk for bleeding; or people who have taken ongoing blood-thinning or anti-clotting medication within 10 days before the first dose.
- People whose tumour has grown into nearby vital organs or blood vessels (such as the aorta, heart, windpipe, or oesophagus), or people at risk of developing an abnormal opening between the oesophagus and the airway or chest cavity.
- People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires repeated draining (people who need drainage less than once a month, or no drainage at all, may still be considered).
- People who have had a blood clot or stroke-related event (such as a stroke, mini-stroke, deep vein thrombosis not related to a previous chemotherapy catheter, or pulmonary embolism) within the 6 months before joining.
- People with active symptoms from brain metastases; people with previously treated and stable brain metastases may be considered if they have been off steroids and anti-seizure medication for at least 1 month and the brain metastases have been stable for at least 1 month.
- People who are unable to provide test results confirming the absence of targetable gene changes or confirming EGFR protein expression of 2+ or higher.
- People with high blood pressure that cannot be adequately controlled with medication (above 140/90 mmHg).
- People who have had a heart attack, severe or unstable chest pain, significant heart failure (rated Class II or above on the NYHA scale), clinically significant abnormal heart rhythms, or symptomatic heart failure within the 6 months before joining.
- People with conditions that significantly affect their ability to absorb oral medication, such as difficulty swallowing, ongoing severe diarrhoea, or a significant bowel blockage.
- People with significant kidney problems, shown by high protein levels in the urine (2+ or more on a urine dipstick test, or 1.0 g or more in a 24-hour urine collection).
- People with HIV infection or AIDS; or people with active hepatitis B or C infection, or a combined hepatitis B and C infection, as defined by specific blood test thresholds.
- People with an active autoimmune disease or a history of autoimmune disease (such as autoimmune hepatitis, bowel inflammation, blood vessel inflammation, or kidney inflammation); people who need inhaled medication for asthma are also excluded; however, people with certain mild conditions such as vitiligo, psoriasis not needing systemic treatment, hair loss not needing systemic treatment, or well-controlled Type 1 diabetes may still be considered.
- People who have had a serious infection requiring hospitalisation within the 4 weeks before the first dose; an active infection requiring systemic antibiotics within 2 weeks before the first dose; unexplained fever above 38.5°C during screening; or evidence of active tuberculosis within the past year.
- People who have had major surgery within 28 days before the first dose (diagnostic biopsies and certain line placements are generally allowed — confirm with trial site).
- People who have previously received a bone marrow transplant from a donor or a solid organ transplant.
- People with a history of substance misuse or psychiatric conditions that are not able to be controlled or managed.
- People with a history of immune system deficiency, including a positive HIV test, other immune deficiency conditions, organ transplantation, or donor bone marrow transplantation.
- People who are currently taking part in another interventional clinical trial (participation in an observational study or the follow-up phase of a completed trial may be permitted).
- Women who are pregnant or currently breastfeeding.
- People with any other condition that, in the trial doctor's judgement, could affect safety, make it difficult to follow the study requirements, or require early withdrawal from the trial (for example, serious other illnesses, alcohol dependence, drug misuse, or difficult personal or family circumstances).
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: 86+ 13853106916
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
Anhui Provincial Cancer Hospital
Registry
ClinicalTrials.gov
Start date
15 July 2026
Est. completion
16 July 2028
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Objective Response Rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 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.