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 given written consent before any trial procedures begin
• Adults aged 18 to 75 years old, of any gender
• People who have been newly diagnosed (no prior treatment) with non-small cell lung cancer (NSCLC) that has been confirmed by tissue testing and is classified as resectable stage II, IIIA, or IIIB (N2) — meaning a qualified chest surgeon has assessed the tumour as removable by surgery
• People whose cancer type is squamous cell carcinoma and who have not tested positive for EGFR, ALK, or ROS1 gene changes; or people with adenocarcinoma who have had genetic testing for at least EGFR, ALK, and ROS1 using an approved testing method, and whose results are negative for those changes
• People whose cancer can be measured using standard imaging criteria (RECIST v1.1)
• People able to provide twenty tissue samples (either freshly collected or archived within the past 3 months) before joining the trial
• People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physically strenuous activity (confirm with trial site)
• People whose blood counts, kidney function, liver function, thyroid function, clotting function, and heart function all fall within the ranges required by the trial
• People whose overall lung function is assessed by the surgeon as sufficient to tolerate the planned lung surgery
• People who agree to use contraception during the study and for 6 months after it ends; women must have a negative pregnancy test within 7 days before starting and must not be breastfeeding

Who may not be able to join:

• People whose cancer is identified as neuroendocrine carcinoma or sarcomatoid tumour
• People whose cancer is locally advanced and cannot be surgically removed, or has spread to other parts of the body
• People with known EGFR mutations or ALK or ROS1 gene rearrangements; non-squamous cell carcinoma patients whose EGFR, ALK, and ROS1 status has not been confirmed
• People who have previously received any systemic anti-cancer treatment (including experimental treatments) for their lung cancer
• People who have had pneumonia or interstitial lung disease (scarring or inflammation of the lung) that required steroid treatment, or who currently have this condition
• People with a known history of active tuberculosis
• People with a known active infection that requires systemic treatment
• People with a known or suspected autoimmune disease or immune deficiency, except those with well-managed hypothyroidism not requiring hormones, or those on low-dose hormone replacement, or those with stable type 1 diabetes with controlled blood sugar
• People with active hepatitis B or hepatitis C, confirmed by specific blood test results
• People known to have HIV infection
• People who have received a live vaccine (such as for measles, chickenpox, yellow fever, rabies, or typhoid) within the 30 days before their first dose
• People with moderate or severe peripheral neuropathy (nerve damage causing symptoms such as numbness or weakness), grade 2 or higher
• People who have previously been treated with PD-1/PD-L1 immunotherapy drugs, or other drugs targeting immune checkpoint receptors such as CTLA-4 or OX-40
• People with severe or uncontrolled medical conditions, including unstable heart disease, uncontrolled high blood pressure, recent heart attack, severe uncontrolled heart rhythm problems, active severe infection, significant liver disease, poorly controlled diabetes, significant protein in the urine, or a history of psychiatric substance misuse
• People who have taken immunosuppressant medications within 2 weeks before starting the trial (except for low-dose steroids or topical steroid creams)
• Women who are pregnant or breastfeeding
• People who are unlawfully imprisoned or involuntarily detained
• People with a known tendency to bleed, active stomach or intestinal ulcers, or who are currently taking blood-thinning medications such as warfarin or heparin
• People with a known allergy to any ingredient in the study drug
• People with other conditions that, in the investigator's judgement, would put them at serious risk or prevent them from completing the study

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