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:

• People who have been diagnosed with Stage IV non-small cell lung cancer (a type of advanced lung cancer, either squamous or non-squamous type), confirmed by a laboratory test on a tissue or cell sample.
• People whose general health and ability to carry out daily activities has been rated at a level of 0 or 1 on a standard medical scale (meaning fully active or able to do light work), assessed within 7 days before joining the trial.
• People who are able to provide either a stored tumour tissue sample or a new tissue sample taken from a tumour that has not previously been treated with radiation.
• People living with HIV, provided their HIV is well controlled with anti-HIV medication.
• People who test positive for hepatitis B, provided they have been on hepatitis B antiviral treatment for at least 4 weeks and the virus is undetectable in their blood before joining the trial.

Who may not be able to join:

• People diagnosed with small cell lung cancer, or whose tumour contains any small cell elements.
• People with squamous-type lung cancer who have a specific gene change known as an EGFR mutation, or an ALK or ROS1 gene rearrangement.
• People living with HIV who have a history of Kaposi's sarcoma or a condition called Multicentric Castleman's Disease.
• People with serious lung problems caused by an existing lung condition, or by autoimmune, connective tissue, or inflammatory diseases that affect the lungs.
• People who have cancer that has spread to the membranes surrounding the brain or spinal cord (leptomeningeal disease).
• People with a known history of, or currently experiencing, a nervous system disorder caused by the immune system's response to cancer (neurologic paraneoplastic syndrome).
• People with a clinically significant eye condition affecting the cornea.
• People who have had a heart attack within the past 6 months.
• People with severe heart failure (classified as Class 3 or 4 on a standard medical scale).
• People who have had uncontrolled chest pain due to reduced blood flow to the heart within the past 6 months.
• People with a heart rhythm problem that requires ongoing medication to manage.
• People with a history of serious heart rhythm problems such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes.
• People whose resting heart rate is below 50 beats per minute, unless a pacemaker is in place.
• People with a history of a second- or third-degree heart block — though those with a pacemaker, no history of fainting, and no significant rhythm problems with their pacemaker may still be considered eligible (confirm with trial site).
• People who have had heart or peripheral artery bypass surgery within the past 6 months.
• People with a complete left bundle branch block (a specific type of electrical problem in the heart).
• People who have not waited long enough after stopping a previous treatment, as specified by the trial requirements, before joining.
• People who have previously been treated with a topoisomerase I inhibitor, an anti-HER3 antibody, or a specific type of antibody-drug combination containing an exatecan-based topoisomerase I inhibitor.
• People who have already received systemic (whole-body) cancer treatment for their advanced lung cancer.
• People who have previously been treated with certain immune checkpoint therapies (anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or similar immunotherapy drugs).
• People who have had radiation therapy within 2 weeks before joining the trial, have side effects from radiation that require steroid treatment, or have had lung inflammation caused by radiation.
• People who have received radiation to the lung above a certain dose level (more than 30 Gray) within the past 6 months.
• People who have received a live or live-attenuated vaccine within 30 days before the first dose of the study treatment.
• People with an immune system deficiency, or who are currently taking steroid or immunosuppressant medications on an ongoing basis within 7 days before the first dose.
• People with another cancer that is growing or has required active treatment within the past 3 years.
• People with active cancer spread to the brain or spinal fluid (active CNS metastases or carcinomatous meningitis).
• People with a known severe allergic reaction to any of the study treatments or their ingredients.
• People with an autoimmune disease that has required systemic treatment within the past 2 years.
• People with an active infection that requires systemic treatment.
• People with both hepatitis B and hepatitis C infections active at the same time.
• People who have not fully recovered from major surgery, or who have ongoing complications from surgery.

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