Early Phase 1 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 given written consent before any trial procedures begin.
• People aged 18 to 75 years old.
• People who have been confirmed by tissue or cell testing to have locally advanced, metastatic, or recurrent squamous non-small cell lung cancer (a specific type of lung cancer), at a stage not suitable for surgery or combined radiation and chemotherapy treatment, and who have not yet received systemic treatment for this cancer.
• People whose cancer either has unknown gene test results, or has been confirmed by tissue testing to not have certain gene changes (specifically EGFR-sensitive mutations or ALK gene fusions).
• People who have at least one measurable area of cancer visible on imaging scans, as assessed using standard medical criteria.
• People who have not previously received systemic anti-cancer treatment for advanced or metastatic disease, or those who received certain earlier chemotherapy or chemoradiotherapy but whose cancer then progressed or came back at least 6 months after their last chemotherapy treatment.
• People with brain metastases (cancer that has spread to the brain) that are either causing no symptoms or have stable symptoms after local treatment, provided certain conditions are met: there is at least one measurable area of cancer outside the brain; brain-related symptoms are absent or have not worsened for at least 2 weeks; and steroid medication is either not needed, was stopped at least 7 days before the first dose, or has been reduced to a low stable dose (confirm with trial site).
• People who have received palliative radiotherapy, provided it was completed at least 7 days before the first dose of the study drug and any side effects from that radiotherapy have mostly resolved.
• People who are in generally good physical condition, as rated by a standard medical scale (ECOG performance status 0 or 1), meaning they are fully active or have minor restrictions in physically strenuous activity.
• People with an expected survival of more than 3 months.
• People whose blood and organ function results meet specific laboratory thresholds for blood cell counts, liver function, kidney function, clotting, thyroid function, and heart enzyme levels (confirm specific values with trial site).
• Women who could potentially become pregnant must have a negative pregnancy test within 3 days before the first dose.
• People who are at risk of pregnancy (male or female) must use highly effective contraception throughout treatment and for up to 120 or 180 days after the last dose (confirm timing with trial site).

Who may not be able to join:

• People whose lung cancer is of a different type, such as adenocarcinoma or small cell lung cancer, including mixed types.
• People who received certain types of radiotherapy shortly before the trial starts, including radiotherapy to a large portion of the bone marrow within 14 days, higher-dose lung radiotherapy within 6 weeks, or palliative radiotherapy within 7 days before the first dose.
• People diagnosed with another type of cancer within the past 5 years, except for certain fully treated skin cancers or completely removed early-stage cancers.
• People currently in another interventional clinical trial, or who received another experimental drug or device within the past 4 weeks.
• People who have previously received certain types of immunotherapy drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immune checkpoint treatments.
• People who received certain immune-boosting or traditional medicines used to treat lung cancer within the 2 weeks before the first dose.
• People who have had an active autoimmune disease requiring systemic medical treatment within the past 2 years (hormone replacement therapies for certain conditions are not counted as systemic treatment).
• People who are currently receiving steroid tablets or other immune-suppressing medicines within 7 days before the first dose, except for low-dose steroids at or below the equivalent of 10 mg per day of prednisone.
• People with pleural or abdominal fluid build-up that is not well controlled (those who do not need drainage or whose fluid is stable may still be considered).
• People with a history of receiving an organ transplant (other than a cornea transplant) or a bone marrow/stem cell transplant from another person.
• People with a known allergy to any of the study drugs (Serplulimab, Nab-Paclitaxel, or carboplatin) or their ingredients.
• People who have not yet recovered from side effects or complications of previous treatments (side effects should be at a mild level or back to baseline, except for tiredness or hair loss).
• People known to be living with HIV (based on a positive HIV antibody test).
• People with untreated active hepatitis B infection (people with hepatitis B whose viral levels are below certain thresholds and who are receiving or will receive appropriate antiviral treatment may still be considered — confirm with trial site).
• People with active hepatitis C infection confirmed by both a positive antibody test and detectable virus levels.
• People who received a live vaccine within 30 days before the first dose (standard injected inactivated flu vaccines are allowed, but live nasal flu vaccines are not).
• People who are pregnant or breastfeeding.
• People with serious or uncontrolled health conditions, including significant heart rhythm problems, unstable chest pain, heart failure, a heart attack within the past 6 months, poorly controlled blood pressure, certain lung diseases, active tuberculosis, uncontrolled infections, certain bowel or liver conditions, poorly controlled diabetes, significant protein in the urine, or serious mental health conditions that would make it impossible to follow the treatment plan.
• People with any other condition, history, or laboratory result that the trial doctor considers may interfere with the trial or make participation unsafe.

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