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 who have been confirmed through a tissue or cell sample to have non-small cell lung cancer (NSCLC) at certain stages (stage IB, II, or stage III with lymph node involvement in a specific pattern), where surgery to remove the cancer is planned as part of treatment. People with two separate NSCLC tumours at the same time may also be eligible.
• People whose cancer can be measured on scans, using a standard set of measurement rules called RECIST v1.1.
• People whose cancer has been tested and the result for a protein called PD-L1 is known (any level).
• People whose cancer has been tested and does not have specific gene changes called EGFR mutations or ALK fusions.
• People aged 18 or older at the time of joining the study.
• People who are generally well enough to carry out everyday activities, rated 0 or 1 on a standard health performance scale used by doctors (ECOG scale), meaning fully active or restricted only in physically strenuous activity.
• People who have not had any previous treatment for their lung cancer.
• People whose blood test results show that their bone marrow, kidneys, and liver are functioning at an adequate level as defined by the trial (confirm specific values with trial site).
• Women who could become pregnant must have a negative pregnancy blood test at the screening stage.
• Women who could become pregnant must agree not to donate eggs during the entire trial and for 6 months after the last treatment.
• All men must agree not to donate sperm during the trial and for 6 months after the last treatment dose.
• Men who are sexually active with a partner who could become pregnant must agree to use condoms, unless they have had a confirmed successful vasectomy or practice full sexual abstinence.

Who may not be able to join:

• People who have had another cancer in the past, unless it was treated with the aim of cure, has shown no signs of returning for at least 2 years, and carries a low risk of coming back — or unless it was a type of skin cancer, pre-cancerous condition, or slow-growing blood cancer that has been adequately treated with no current evidence of disease.
• People who have used immune-suppressing medications in the 14 days before the first study dose, with some exceptions such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions (confirm details with trial site).
• People who need ongoing steroid medication at a dose higher than 10 mg of prednisone per day (or equivalent) within the week before starting the study, unless only a very short course is needed.
• People who have an active or past diagnosed autoimmune or inflammatory condition — such as lupus, Crohn's disease, rheumatoid arthritis, or similar — with some exceptions including vitiligo, hair loss (alopecia), stable thyroid or other hormonal conditions managed with replacement therapy, chronic skin conditions not needing systemic treatment, or childhood asthma that has fully resolved.
• People with active diverticulitis within the past 3 months.
• People with serious uncontrolled ongoing health problems, such as an active infection requiring antibiotics (unless a short antibiotic course will be finished before treatment starts), heart failure, unstable chest pain, or significant mental health or social circumstances that could affect their ability to follow the study requirements.
• People with a lung condition called interstitial lung disease, or active non-infectious lung inflammation requiring high-dose immune-suppressing steroid treatment.
• People who have received a live vaccine within 30 days before the planned start of study treatment (specific guidance applies to COVID-19 vaccines — confirm with trial site).
• People who have previously had a stem cell transplant from a donor or a solid organ transplant (such as a kidney or liver transplant).
• People with uncontrolled HIV, active hepatitis B or C, an immune deficiency condition, or active or latent tuberculosis — though people with well-controlled HIV, hepatitis B, or hepatitis C meeting specific medical criteria may still be eligible (confirm with trial site).
• Women who are pregnant or breastfeeding.
• Sexually active women who could become pregnant, or sexually active men, who are unwilling to use highly effective contraception before, during, and for at least 6 months after treatment (or at least 4 months for men). Some contraception methods are not accepted — confirm acceptable methods with the trial site.
• People with significant heart or blood vessel disease, including certain levels of heart failure, a heart attack or acute coronary event within the past 12 months, or a stroke or mini-stroke within the past year.
• People with a known serious allergic reaction to the study drug or any of its ingredients.
• People who have had an infection serious enough to require hospital treatment or intravenous antibiotics within 2 weeks before the first study dose.

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