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 are able to give written consent and follow the study schedule and procedures.
• People aged 18 years or older.
• People diagnosed with a type of lung cancer called non-small cell lung cancer (NSCLC) — either adenocarcinoma or squamous cell carcinoma — confirmed by tissue or cell testing.
• People whose cancer is at a specific stage (stage IIB with a tumour larger than 4cm, stage IIIA, or a specific type of stage IIIB), and where surgery to remove the cancer is considered possible.
• People with non-squamous NSCLC whose genetic testing confirms the absence of certain gene changes (EGFR mutations and ALK rearrangements); people with squamous NSCLC do not need this testing, but those known to have these gene changes cannot be included.
• People whose cancer is considered suitable for surgery with the goal of removing it completely.
• People whose lung function test results are strong enough to safely undergo the planned lung surgery (confirm with trial site for specific values).
• People who can provide a tissue sample that is sufficient for a specific protein test (PD-L1 testing) during the screening period.
• People who have at least one tumour that can be measured on a scan, according to standard criteria.
• People with a general health score of 0 or 1 on a standard scale, meaning they are fully active or have only minor limitations in physical activity.
• People who have not previously received any cancer treatment (systemic therapy or radiation) for this lung cancer.
• People whose blood, liver, kidney, and clotting test results fall within the required ranges in the week before joining (confirm with trial site for specific values).
• Women of childbearing age whose pregnancy test (urine or blood) is negative in the week before starting the study drug.
• People who are willing to use highly effective contraception during the trial and for at least 180 days after stopping treatment, if there is any possibility of conception.

Who may not be able to join:

• People whose tumour biopsy also shows certain other cancer types, such as small cell carcinoma, large cell neuroendocrine tumour, or sarcomatoid components.
• People whose tumour has grown into nearby structures such as the heart, major blood vessels, spine, windpipe, or oesophagus.
• People with a tumour located at the top of the lung (called a superior sulcus tumour).
• People who have tumour nodules in the opposite lung from the main tumour.
• People who have confirmed or suspected cancer that has spread to the brain.
• People currently taking part in another interventional clinical trial, or who have received an experimental drug or device within the 4 weeks before joining.
• People who have previously been treated with certain types of immunotherapy drugs that work on immune checkpoint pathways (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 drugs, or adoptive cell immunotherapy).
• People who have used certain traditional Chinese herbal medicines or immune-modulating drugs (such as thymic peptides, interferon, or interleukin) within the 2 weeks before joining.
• People who have had major surgery within the 4 weeks before joining.
• People who have unhealed surgical wounds, ulcers, or fractures.
• People who have received a live attenuated vaccine within the 4 weeks before joining, or who plan to receive one during the study (injected inactivated flu vaccines are permitted; live flu vaccines are not).
• People who require long-term daily use of corticosteroid (steroid) medicines, or who have received immunosuppressive treatment in the 7 days before joining (low-dose or locally applied steroids may be permitted — confirm with trial site).
• People who have had non-infectious pneumonia (lung inflammation) requiring steroid treatment within the past year, or who currently have interstitial lung disease.
• People who have had an active autoimmune disease requiring systemic treatment within the past 2 years (such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or similar conditions).
• People with a primary immune deficiency condition.
• People with a history of heart muscle inflammation (myocarditis), either past or present.
• People who have not yet recovered from side effects of any previous medical procedures (confirm with trial site for grading details).
• People with moderate or severe nerve damage in their hands or feet (grade 2 or higher peripheral neuropathy).
• People with a known tendency to bleed or clot abnormally, or who have had a serious blood clot, stroke, heart attack, or similar event within certain timeframes before joining (confirm with trial site for specific timeframes).
• People with uncontrolled high blood pressure or uncontrolled high blood sugar levels, or a history of hypertensive crisis or hypertensive brain complications.
• People with certain unstable or serious ongoing health conditions, including active infection, significant heart failure, serious irregular heartbeat, untreated coronary artery disease, respiratory failure, or recent history of serious bowel problems.
• People who have had a solid organ or bone marrow transplant.
• People with a known HIV infection or active syphilis.
• People with active tuberculosis or other conditions requiring tuberculosis treatment.
• People with active hepatitis B (some people with hepatitis B history may still be eligible under specific conditions — confirm with trial site).
• People with active hepatitis C (confirmed by positive antibody test and detectable virus levels).
• People who have had another type of cancer in the past 5 years, with some exceptions for certain fully treated cancers such as early-stage skin cancer, cervical carcinoma in situ, or specific thyroid or prostate cancers after complete treatment.
• People with a known allergy to the chemotherapy drugs used in this trial (specific drugs depend on the type of NSCLC — confirm with trial site).
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
• People with known mental health conditions, drug misuse, or alcohol misuse that may make it difficult to follow the study requirements.
• People with other medical history, conditions, or test results that, in the treating doctor's judgement, could interfere with the trial or make participation not in the person's best interest.

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