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 signed a written consent form before any trial-related procedures begin.
• People aged 18 to 70 years, of any gender.
• People who have been confirmed through a tissue or cell sample to have inoperable, locally advanced non-small cell lung cancer (NSCLC) at stage IIB to IIIC, as determined by a specialist team or thoracic surgeon.
• People with no signs of cancer that has spread to distant parts of the body, confirmed through scans of the chest, abdomen, pelvis, and brain, and/or a whole-body PET/CT scan.
• People whose tumour tissue shows a PD-L1 protein expression level of 20% or higher, tested using specific approved laboratory methods.
• People who have at least one tumour lesion that can be measured on scans according to standard criteria (RECIST 1.1).
• People who have not previously received treatment for advanced or metastatic NSCLC — though those who received induction or neoadjuvant therapy (chemotherapy or immunotherapy) before planned definitive chemoradiotherapy may still be considered.
• People who previously received certain types of immunotherapy (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, LAG-3 inhibitors, or TIGIT monoclonal antibodies) as induction treatment may still be considered.
• People with a good general health status, rated 0 or 1 on the ECOG performance scale (meaning fully active or restricted in strenuous activity but able to carry out light work).
• People with a life expectancy of at least 6 months.
• People whose blood tests show that their organs (such as liver, kidneys, and bone marrow) are functioning adequately (confirm specific values with trial site).
• Women who could become pregnant must have a negative pregnancy test within 3 days before the first dose.
• All participants at risk of pregnancy must use a highly effective contraceptive method (less than 1% failure rate) throughout treatment and for 120 days after the last dose of the study drug, or 180 days after the last dose of chemotherapy.

Who may not be able to join:

• People diagnosed with small cell lung cancer (SCLC), or a mixed tumour that contains small cell components.
• People who have already had genetic testing showing sensitive mutations in the EGFR, ALK, or ROS-1 genes.
• People with a type of lung cancer that forms cavities, or where scans suggest the tumour is growing into major blood vessels, or who have had active coughing up of significant amounts of fresh blood within 2 weeks before the first dose.
• People for whom the planned radiation treatment would expose too large a volume of healthy lung tissue to high doses of radiation, or who have previously received any radiotherapy to the chest area (including for oesophageal, mediastinal, or breast cancer).
• People who have had major surgery within 3 weeks before the first dose (minor procedures like biopsies or port placements are generally excluded from this rule, but full recovery is required).
• People who have been diagnosed with another cancer within the past 5 years, except for certain skin cancers or localised cancers that were fully removed by surgery.
• People currently enrolled in another interventional clinical trial, or who have received another experimental drug or device within 4 weeks before the first dose.
• People who have received certain traditional Chinese medicines with anti-cancer indications, or immune-modulating drugs such as thymosin, interferons, or interleukins within 2 weeks before the first dose.
• People who have had an active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapies for conditions like thyroid or adrenal insufficiency are not considered systemic treatment in this context).
• People currently taking systemic steroid (glucocorticoid) medications or other immune-suppressing drugs within 7 days before the first dose, except for low physiological doses (confirm acceptable dose levels with trial site).
• People who cannot stop taking aspirin or certain anti-inflammatory medicines around the time of pemetrexed chemotherapy doses, or who are unable or unwilling to take folic acid, vitamin B12, and dexamethasone as required (applies specifically if pemetrexed is part of the treatment plan).
• People with a history of organ transplantation (other than corneal transplants) or bone marrow/stem cell transplantation from a donor.
• People with known allergies to any of the study drugs or their ingredients, including the immunotherapy antibody, pemetrexed, paclitaxel formulations, carboplatin, or cisplatin.
• People with a history of bleeding problems (such as active stomach ulcers) or who are taking blood-thinning medications, unless on very low preventative doses that meet specific criteria (confirm with trial site).
• People who have had a serious blood clot or stroke event (including transient ischaemic attacks, deep vein thrombosis, or pulmonary embolism) within 6 months before the first dose.
• People who have not yet fully recovered from side effects or complications of previous treatments (side effects must be at a mild or baseline level, with the exception of fatigue or hair loss).
• People with a known HIV infection.
• People with untreated, active hepatitis B infection — though people with low or undetectable hepatitis B virus levels who are receiving or will receive antiviral treatment may still be considered (confirm with trial site).
• People with active hepatitis C infection confirmed by blood tests.
• People who have received a live vaccine within 30 days before the first dose (certain inactivated vaccines such as standard flu shots and COVID-19 vaccines are generally permitted; live nasal spray flu vaccines are not).
• People who are pregnant or breastfeeding.
• People with severe or uncontrolled serious illnesses affecting other body systems (confirm specific conditions with trial site).
• People with any other medical history, condition, or abnormal test result that the trial investigator considers would interfere with the study or make participation unsafe.

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