Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• (Part 1) People with a confirmed advanced or metastatic solid tumour that has come back or stopped responding to treatment, and for whom no standard treatment options remain.
• (Part 2) People with confirmed advanced or metastatic non-small cell lung cancer (NSCLC) at Stage IIIB/C or IV, where standard treatments such as surgery, radiation, or systemic therapy have been received or are not suitable.
• (Part 1) People whose tumour has a specific genetic change in the MET gene — such as a METex14 mutation, certain MET kinase domain mutations, or MET amplification — confirmed through a blood or tissue test.
• (Part 2a) People whose tumour has a METex14 mutation confirmed by local blood or tissue testing; or (Part 2b) people with a METex14 mutation or de novo MET amplification confirmed by local tissue testing. Central laboratory confirmation will also be required using stored or fresh tumour tissue.
• (Part 2) People who have at least one tumour that can be measured on scans, according to standard measurement guidelines (RECIST v1.1).
• People who are relatively well and able to carry out daily activities, rated 0 or 1 on a standard medical performance scale (ECOG scale).
• (Part 1) People who have previously received a MET-targeted treatment (called a MET TKI, including crizotinib), at any point in their treatment history.
• (Part 2) People who have received no more than three prior rounds of systemic cancer treatment.
• People whose blood tests show adequate function of the blood, liver, kidneys, and heart, as well as adequate protein (albumin) levels and normal blood clotting.
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before starting the trial drug, and a negative urine pregnancy test on the first day of treatment.
• Men whose partners could become pregnant must agree to use appropriate measures to prevent pregnancy during the trial.

Who may not be able to join:

• (Part 2) People whose tumour has a different targetable genetic driver mutation identified by local testing.
• People with a history of another cancer, unless that cancer was fully treated at least 2 years ago with no signs of remaining disease, or unless it was a type with a very low risk of spreading or causing death (with a 5-year survival rate above 90%) and has been adequately treated.
• People with brain or spinal cord metastases that are not under control and are causing worsening neurological symptoms, or that require increasing doses of steroid medication.
• People with a known allergy or sensitivity to VERT-002 or similar drugs.
• People with an active bacterial, fungal, or viral infection within 2 weeks before the first dose.
• People who have tested positive for COVID-19 (SARS-CoV-2 or its variants) within 2 weeks before the first dose, or who are awaiting confirmation of a suspected COVID-19 infection.
• People with significant heart or cardiovascular problems, either currently active or occurring within the 6 months before signing consent.
• People with uncontrolled illness — including mental health conditions or life circumstances — that would make it difficult to follow the trial requirements.
• People with a history of interstitial lung disease (scarring or inflammation of the lungs), lung inflammation caused by medication, or radiation-related lung inflammation requiring steroid treatment, or any currently active lung inflammation of this type.
• Women who are pregnant or breastfeeding.
• People who have received a MET-targeted treatment (MET TKI) within 7 days before the first dose, other systemic cancer treatments within 28 days (or 5 half-lives, whichever is shorter, with a minimum of 14 days) before the first dose, or certain types of radiotherapy within 14 days before the first dose.
• People who have received a live vaccine within 28 days before the first dose.
• People still experiencing side effects from previous cancer treatment rated above Grade 1 on a standard scale at the time of the first dose (exceptions apply for hair loss, fatigue, and mild-to-moderate peripheral nerve symptoms).
• People who have had major surgery within 14 days before the first dose.
• People who have taken an experimental drug in another clinical trial within a specified washout period before the first dose (confirm exact timing with trial site).

Important: Always verify eligibility with the trial site directly before applying.