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 are willing and able to sign a consent form and follow the study schedule and procedures.
• People who are 18 years of age or older, of any sex.
• People whose lung cancer has been confirmed through tissue or cell testing to be non-small cell lung cancer (NSCLC).
• People whose lung cancer is classified as stage IB to IIIA according to a standard international staging system for lung cancer.
• People whose tumour has a specific genetic change called KRAS G12C, confirmed by a written test report, and whose tumour does not have certain other genetic changes (called EGFR or ALK mutations).
• People whose surgeon has assessed that the tumour can be fully removed by surgery, and whose lung function is strong enough to support the planned operation.
• People who have at least one tumour that can be measured using standard imaging criteria.
• People whose general physical functioning is rated as 0 or 1 on a standard scale (meaning fully active or able to carry out light activity).
• People who have not previously received any systemic anti-cancer treatment for advanced or spread NSCLC.
• People whose blood, liver, kidney, and clotting function results fall within the ranges required by the study, based on recent blood tests.
• People who are able to use effective contraception throughout the treatment period and for 180 days after treatment ends — this applies to women who could become pregnant and to men whose partners could become pregnant.
• Women who are either past menopause or have a negative pregnancy test before joining the trial.

Who may not be able to join:

• People whose cancer includes certain other tumour types such as small cell carcinoma, neuroendocrine carcinoma, sarcoma, or other non-NSCLC components confirmed by testing.
• People whose tumour has grown into nearby structures such as the diaphragm, heart, major blood vessels, windpipe, oesophagus, or spine.
• People with a tumour located in the upper part of the lung affecting the shoulder and neck area (called a Pancoast or superior sulcus tumour).
• People who have tumour nodules in the opposite lung from the main cancer.
• People with confirmed spread of cancer to the brain, or suspected spread that has not been ruled out by imaging.
• People who have had significant heart or blood vessel problems within the past 6 months, such as a heart attack, heart failure, serious irregular heartbeat, or procedures such as bypass surgery or stent placement.
• People with a heart rhythm measurement (QTcF interval) that is abnormally prolonged (above 470ms for women or above 450ms for men).
• People with significant or active gut or digestive disease where ongoing diarrhoea is a major symptom.
• People who have taken certain medications that strongly affect how the body processes drugs (strong CYP3A4 or P-gp inhibitors or inducers) within 14 days or 5 half-lives before the first dose, whichever is longer, or certain traditional Chinese medicines within 7 days before the first dose.
• People who have recently taken certain other medications that interact with specific drug-processing pathways in the body, where the safe dosing range is very narrow (confirm with trial site).
• People who have taken proton pump inhibitors (such as omeprazole) or H2 blockers (such as ranitidine) within 7 days before the first dose.
• People who have received certain Chinese herbal medicines with anti-cancer effects, or immune-modifying treatments such as interferons or interleukins, within 2 weeks before the first dose.
• People who are currently taking part in another interventional clinical trial.
• People who have received a live vaccine within 4 weeks before the first dose, or who plan to receive one during the study (note: injected inactivated flu vaccines are permitted; live flu vaccines are not).
• People who need long-term steroid treatment taken throughout the body, or who have had other immune-suppressing therapy within 7 days before joining (note: low-dose, topical, or inhaled steroids may be permitted — confirm with trial site).
• People who have had major surgery (such as brain, chest, or abdominal surgery) within 4 weeks before the first dose, or who have wounds, ulcers, or fractures that have not healed.
• People with a history of lung inflammation conditions such as radiation pneumonitis, pulmonary fibrosis, or organising pneumonia.
• People who are known to be allergic to the study drug or any of its ingredients.
• People with a known primary immune system deficiency.
• People with active autoimmune or inflammatory diseases such as lupus, Crohn's disease, colitis, or Graves' disease, or a history of such conditions within the past 2 years (note: some conditions such as stable vitiligo, thyroid replacement-only hypothyroidism, and insulin-only type 1 diabetes may still be eligible — confirm with trial site).
• People with significant active or chronic infections, including infections currently requiring treatment, HIV, active hepatitis B or C, active tuberculosis, or active syphilis.
• People who have had an organ transplant or bone marrow/stem cell transplant from another person.
• People diagnosed with another cancer in the past 5 years, with some exceptions such as certain treated skin cancers, early-stage prostate cancer, papillary thyroid cancer, or carcinoma in situ that has been fully removed (confirm with trial site).
• People with a range of other uncontrolled medical conditions, including serious recent infections, advanced heart failure, uncontrolled high blood pressure, uncontrolled high calcium levels, high risk of bleeding from veins in the oesophagus or stomach, recent blood clots in deep veins, recent life-threatening bleeding, severe malnutrition, bowel obstruction risk, recent bowel perforation or fistula, or stents placed in the oesophagus or airway.
• People with psychological, neurological, or social conditions that would make it difficult to safely participate in or comply with the study.
• Women who are pregnant or breastfeeding.

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