Phase 2 Lung Cancer Trial, Recruiting

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

Who might be able to join this trial:

• Adults aged 18 or older at the time of signing consent forms.
• People who have signed written consent forms before registering for the trial.
• People with a general health status rated as 0, 1, or 2 on a standard medical performance scale (meaning able to carry out at least some daily activities), assessed within 28 days before registration.
• People whose doctor estimates they have a life expectancy of 6 months or more.
• People diagnosed with a specific type of lung cancer called squamous non-small cell lung cancer (sqNSCLC), confirmed by laboratory testing of tissue or cells.
• People with stage IV (advanced) squamous non-small cell lung cancer who have not yet received treatment for their stage IV disease, including those whose cancer has come back or spread locally and who are candidates for a first round of treatment.
• People whose cancer showed complete response, partial response, or stable disease after the first round (induction) of treatment — only these patients will be eligible for the maintenance phase of the trial involving the two study drugs.
• People whose tumour has been tested for a protein called PD-L1.
• People whose blood and organ function test results meet specific minimum levels (including blood cell counts, kidney function, liver function, and other measures), tested within 14 days before registration.
• People who have recovered from side effects of any previous treatments to a mild or baseline level before starting the trial.
• People who are sexually active and who agree to use medically accepted contraception during the study and for 4 months after the last dose of each study drug.
• Women who could become pregnant must have a negative blood pregnancy test within 3 days before registration.
• Women who are post-menopausal or have had permanent surgical sterilisation meet an alternative requirement in place of the pregnancy test (confirm with trial site).
• People who are able and willing to understand and follow the trial requirements, attend scheduled visits, and complete all required procedures.

Who may not be able to join:

• People with an active infection currently requiring treatment with systemic (whole-body) medicines.
• People who are pregnant or breastfeeding.
• People who have previously been treated with the drug cabozantinib.
• People who have taken a small molecule kinase inhibitor (a type of targeted cancer drug) within 2 weeks before the first dose of study treatment.
• People who have received any systemic (whole-body) cancer therapy, including chemotherapy, biological therapy, or similar treatments, within 4 weeks before the first dose of study treatment.
• People who have received radiation therapy to bone within 2 weeks, radiation therapy to any other area within 4 weeks, or radioactive substance treatments within 6 weeks before the first dose of study treatment — or people experiencing ongoing significant complications from prior radiation.
• People whose scans show cancer growing into or around a major blood vessel.
• People with scan evidence of large hollow (cavitating) lesions in the central part of the lungs, or cancer growing inside the airways (confirm with trial site for details about peripheral cavitary lesions).
• People whose cancer has a specific genetic change for which a targeted therapy approved by the FDA already exists (such as changes in genes including EGFR, ALK, ROS1, RET, MET, BRAF, or NTRK).
• People with serious uncontrolled heart conditions, including severe heart failure, unstable chest pain, serious irregular heart rhythms, or uncontrolled high blood pressure despite treatment.
• People who have had a stroke, heart attack, or blood clot (such as in the legs or lungs) within 6 months before the first dose of study treatment (a small exception exists for stable, asymptomatic minor clots being treated with anticoagulants — confirm with trial site).
• People with serious stomach or bowel conditions, including active ulcers, inflammatory bowel disease, or recent bowel perforation, obstruction, or abdominal abscess within 6 months before the first dose.
• People with serious non-healing wounds, severe problems absorbing food through the gut, uncontrolled thyroid problems, moderate-to-severe liver impairment, or who require dialysis.
• People who need regular high-dose steroid medicines or other immune-suppressing medicines (above a low threshold), taken within 2 weeks before the first dose (some exceptions apply — confirm with trial site).
• People who have had clinically significant bleeding — including coughing up more than half a teaspoon of blood — within 12 weeks before the first dose.
• People with brain metastases (cancer spread to the brain) that have not been adequately treated and stable for at least 4 weeks, or who still need steroid medicines for brain symptoms.
• People currently taking certain blood-thinning medicines such as warfarin, dabigatran, clopidogrel, or betrixaban (some other blood thinners may be permitted — confirm with trial site).
• People who have received a live vaccine within 30 days before the first dose of study treatment.
• People with uncontrolled autoimmune disease, immune deficiency, certain lung conditions (such as pulmonary fibrosis or pneumonitis), HIV, active hepatitis B or C, or a positive tuberculosis test.
• People with a known allergy or serious reaction to any component of the study drugs, or a history of severe reactions to monoclonal antibody treatments.
• People with certain rare inherited conditions affecting how the body processes certain sugars (galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption).
• People with another active cancer, or who were diagnosed with another cancer within the past 3 years that requires active treatment (some exceptions exist for certain curable skin or superficial cancers — confirm with trial site).
• People who have had major surgery within 2 weeks, or minor surgery within 10 days, before the first dose of study treatment, or who have not fully healed from surgery.
• People who have previously received a solid organ transplant or a stem cell/bone marrow transplant from a donor.
• People with a known allergy to cabozantinib or any of its ingredients.
• People who are unable to swallow tablets or unable to receive intravenous (IV) treatment.
• People whose heart's electrical activity (measured by ECG) shows a specific reading (QTcF) above 500 ms, or who have a history of a heart rhythm condition called long QT syndrome.
• People with any other serious medical, psychiatric, or laboratory condition that, in the investigator's judgement, would make participation unsafe or affect the trial's results.
• People whose medical or mental health condition prevents them from giving informed consent or taking part in the trial.

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