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:

• People aged 18 or older who have been diagnosed with non-small cell lung cancer (NSCLC) confirmed by a tissue test
• People whose lung cancer is at Stage II, Stage IIIA, or certain Stage IIIB cases (specifically T3N2 or T4 based on tumour size, not because the cancer has grown into chest organs), as defined by standard cancer staging guidelines
• People whose lung cancer tumour testing — from either a tissue sample taken within the last 6 months, or a blood sample taken within the last 3 months — has shown a specific change (mutation or amplification) in a gene called HER2, tested by an approved laboratory
• People whose cancer can be measured on scans according to standard criteria (RECIST v1.1), and whose tumour appears solid or part-solid on CT scan (not purely ground-glass in appearance)
• People who have been assessed by a thoracic (chest) surgeon and confirmed to have a tumour that can be completely removed by surgery, and who are considered medically fit for surgery
• People with lung function test results showing enough breathing capacity to undergo surgery with the goal of curing the cancer (specific measurements must meet set thresholds)
• People with a heart scan (echocardiogram) done within 28 days before joining the trial showing the heart is pumping adequately (left ventricular ejection fraction of 50% or higher)
• People with a general fitness/activity level rated as ECOG 0 or 1, meaning fully active or able to carry out light work
• People with blood test results within acceptable ranges taken within 14 days before starting treatment, covering white blood cells, platelets, clotting, red blood cells, liver function, kidney function, and protein levels (specific thresholds apply for each)
• People who are able and willing to use highly effective contraception, or to avoid intercourse, during the study and for at least 4.5 months after the last dose of study treatment (applicable to people of reproductive potential; specific methods are listed in the protocol)
• People who are willing and able to attend study visits and follow the study procedures

Who may not be able to join:

• People whose lung cancer has grown into chest organs (mediastinal invasion) or whose cancer has spread to lymph nodes on both sides of the chest (N3 disease, Stage IIIB by that definition)
• People whose surgeon determines that removing the entire lung (total pneumonectomy) would be needed to fully remove the cancer
• People who have received any previous treatment for lung cancer — including chemotherapy, targeted therapy, immunotherapy, or radiotherapy — within the past 3 years
• People with a previous lung cancer that has been in remission for less than 3 years (with some exceptions for very low-risk cancer types)
• People with a history of lung inflammation (ILD or pneumonitis) that required steroid treatment, or who currently have or are suspected to have this condition
• People with significant ongoing lung conditions, such as a blood clot in the lungs within the past 3 months, severe asthma, severe COPD, restrictive lung disease, or fluid around the lungs
• People with autoimmune, connective tissue, or inflammatory conditions (such as rheumatoid arthritis or sarcoidosis) where there is evidence or suspicion of lung involvement
• People who have previously had a complete removal of one lung (pneumonectomy)
• People with an active, uncontrolled infection currently requiring intravenous antibiotics, antiviral, or antifungal treatment
• People with active HIV that is not controlled, active hepatitis B or C infection, or a primary immune deficiency condition (some people with past hepatitis B may still be eligible — confirm with the trial site)
• People with an abnormal heart rhythm measurement (QT interval) on an ECG above specific thresholds (470 milliseconds for women, 450 milliseconds for men)
• People who have received a live, weakened (attenuated) vaccine within 30 days before starting treatment (note: mRNA vaccines and certain other types are not considered live attenuated vaccines)
• People with a known allergy or sensitivity to the study drug or any of its ingredients
• People with a history of severe allergic reactions to other similar medicines (monoclonal antibodies)
• People with substance use issues or other medical conditions that the trial doctor believes would make participation unsafe or affect results
• People who have had a major surgical procedure within 28 days before starting treatment
• People diagnosed with another cancer within the past 3 years, with some exceptions for cancers considered very low risk or already treated with curative intent (confirm with trial site)
• People who have taken part in another clinical trial or used an investigational medicine within 4 weeks before starting treatment (or within 5 half-lives of that medicine, whichever is longer)
• People with a history of heart attack, significant heart failure, unstable chest pain (angina), or serious heart rhythm problems
• People with social, family, or location-related circumstances that would make it difficult to participate in or complete the study
• People with other medical conditions that the trial doctor believes would increase the risk of side effects
• People who are pregnant, breastfeeding, or planning to become pregnant during the study; women who could become pregnant must have a negative pregnancy blood test within 7 days before starting treatment
• Male participants must not donate or freeze sperm during the study and for at least 4.5 months after the last dose; female participants must not donate eggs or retrieve eggs for personal use during the study and for at least 7 months after the last dose

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