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 signed a consent form before any trial-related procedures begin.
• People aged 18 to 75 years (male or female).
• People who have been confirmed through tissue or cell testing to have a type of lung cancer called non-small cell lung cancer (NSCLC).
• People who have already received 3 to 4 cycles of pre-surgery treatment combining an immunotherapy drug (a PD-1 inhibitor) with chemotherapy.
• People who have had a type of lung surgery (lobectomy or sleeve lobectomy) where all visible tumour was fully removed, all surgical edges were clear of cancer, and lymph nodes were also removed and examined.
• People whose lung cancer was classified as stage II, IIIA, or a specific form of stage IIIB (resectable N2, meaning limited lymph node involvement with affected nodes smaller than 3 cm) according to a standard staging system called AJCC 8th edition (confirm with trial site if unsure about staging).
• People whose post-surgery tumour assessment showed between 1% and 90% of living tumour cells remaining in the removed tissue.
• People whose cancer does not have certain specific genetic changes (EGFR mutations, ROS1 fusions, ALK fusions, or RET fusions); other genetic changes will be assessed in discussion with the trial sponsor.
• People who had no cancer treatments before surgery other than PD-1 immunotherapy and chemotherapy.
• People who completed their lung cancer surgery 4 to 12 weeks before joining the study, with laboratory confirmation that all cancer was removed and a scan taken one month after surgery showing no remaining tumour.
• People who are generally well enough to carry out normal daily activities with little or no limitation, based on a standard medical scale (ECOG score of 0 or 1).
• People whose life expectancy is greater than 6 months.
• People whose blood, liver, kidney, thyroid, heart enzyme, and clotting test results are within acceptable ranges as determined by the trial team.
• Women who could potentially become pregnant must have a negative pregnancy test within 3 days before the first trial treatment.
• All participants at risk of conception must use highly effective contraception throughout treatment and for 120 days after the last dose of study drug (or 180 days after the last chemotherapy dose).
• People who are willing to provide tissue from their surgery and blood samples for a test that looks for traces of cancer in the blood (called MRD assessment).

Who may not be able to join:

• People who have been diagnosed with another type of cancer in the past 5 years (some fully treated skin cancers or completely removed early-stage cancers may be exceptions — confirm with trial site).
• People who have already received radiotherapy after their surgery.
• People who had their entire lung removed (pneumonectomy) rather than just a section.
• People currently in another interventional clinical trial, or who have taken an experimental drug or used an experimental medical device within the past 4 weeks.
• People who received any pre-surgery anti-cancer treatment other than chemotherapy and immunotherapy.
• People with surgical wounds, ulcers, or bone fractures that have not yet healed.
• People with serious ongoing health conditions that, in the opinion of the treating doctor, could affect their ability to complete the study; also, people with certain immune system antibody results will need further assessment before being considered eligible (confirm with trial site).
• People with a condition where their immune system does not work properly from birth (primary immunodeficiency).
• People taking steroid tablets or injections throughout the body within 7 days before the first trial treatment (low-dose steroids of 10 mg per day or less of prednisone, or equivalent, may be allowed; nasal sprays, inhalers, or skin-applied steroids are generally permitted — confirm with trial site).
• People who have had an organ transplant from another person (except a corneal transplant), or a stem cell transplant from another person.
• People with a known allergy to the trial drug, sintilimab, or any of its ingredients.
• People who have not yet sufficiently recovered from side effects or complications of any previous treatment before starting the trial (confirm with trial site regarding what level of recovery is required).

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