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 willing to take part voluntarily and sign a consent form.
• People aged 18 to 75 years old at the time of signing the consent form.
• People with a life expectancy of at least 3 months.
• People who have been diagnosed through tissue or cell testing with non-small cell lung cancer (a type of lung cancer) that cannot be surgically removed, has spread to other parts of the body, or has come back, and who are not suitable for a combined chemotherapy and radiotherapy treatment aimed at cure.
• People whose lung cancer has been confirmed by a certified laboratory to have a specific gene change called a KRAS G12C mutation.
• People whose general health and ability to carry out daily activities is rated as 0 or 1 on a standard medical scale (meaning fully active or restricted in strenuous activity only).
• People who have not previously received systemic (whole-body) anti-cancer treatment for advanced or metastatic lung cancer — though people who received earlier preventive treatment after surgery may still be eligible if their cancer came back at least 6 months after finishing that treatment or radiotherapy.
• People who have at least one tumour that can be measured on scans according to standard criteria.
• People whose blood counts, liver, kidney, clotting, and magnesium levels meet certain minimum thresholds set by the trial (confirm with trial site for exact values).
• People whose side effects from any previous cancer treatment have mostly resolved, with only mild or no ongoing effects (some exceptions apply, such as stable hormone-related side effects from immunotherapy).
• People who are able to use effective contraception from the time of signing the consent form until 6 months after the last dose of the study drug — this applies to women who could become pregnant and to men whose partners could become pregnant.
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before the first dose.

Who may not be able to join:

• People whose lung cancer contains a mix of small cell components or is predominantly a type called squamous cell carcinoma.
• People whose cancer has certain other gene changes (such as EGFR, ALK, or ROS-1) for which approved first-line treatments already exist.
• People who have had a significant heart or blood vessel problem in the past 6 months, such as a heart attack, serious abnormal heart rhythm, or heart failure, or who have had a procedure such as stenting or bypass surgery — or people with a specific abnormality in their heart's electrical activity detected on a heart tracing (ECG).
• People who have had a significant brain or stroke-related event (such as a bleed in the brain or a stroke) in the past 3 months.
• People with active, currently growing cancer spread to the brain or the lining of the brain — though people with previously treated and stable brain metastases may still be considered eligible (confirm with trial site).
• People with significant lung conditions such as serious inflammation of the lung tissue (interstitial lung disease), active tuberculosis of the lung, severe breathing impairment, or lung damage from previous treatment.
• People with significant digestive problems that could affect the ability to swallow or absorb tablets, such as severe nausea, active bleeding in the digestive tract, or liver cirrhosis.
• People with active infections requiring treatment, HIV, active hepatitis B or C, or active tuberculosis.
• People who have fluid build-up around the lungs, abdomen, or heart that requires repeated draining.
• People with poorly controlled high blood pressure or diabetes despite standard treatment.
• People who have had another active cancer within the past 2 years, with some exceptions for certain low-risk or easily treated cancers (confirm with trial site for specific exceptions).
• People who have previously been treated with a KRAS G12C inhibitor (a type of targeted cancer drug).
• People who have previously been treated with cetuximab or similar medicines.
• People who have recently used certain herbal medicines with anti-cancer properties, or certain immune-modifying drugs, within a short period before the first dose (confirm with trial site for exact timeframes).
• People who have had radiotherapy (other than to the brain) or certain local cancer treatments within 14 days before the first dose.
• People who have received other anti-cancer treatments — such as chemotherapy, targeted therapy, immunotherapy, or another trial drug — within 28 days (or a shorter period depending on the drug) before the first dose.
• People who have had major surgery within 28 days before joining the trial that could affect the study.
• People currently taking certain specific medicines that interact with the study drug in a narrow and sensitive range (confirm with trial site for details).
• People currently taking part in another interventional clinical trial.
• People who have used immune-suppressing medicines within 4 weeks before the first dose, with some exceptions for low-dose or locally applied steroids.
• People who have received a live vaccine within 4 weeks before the first dose, or who plan to receive one during the study.
• People with a known or suspected autoimmune disease, or a history of one within the past 2 years — though some mild autoimmune conditions that do not require systemic treatment may still be eligible (confirm with trial site).
• People with a known history of a primary immune system deficiency.
• People who have had an organ transplant or bone marrow/stem cell transplant from a donor.
• People who have had a serious blood clot event such as a deep vein thrombosis or pulmonary embolism within the past 3 months.
• People with a known allergy to any ingredient in the study drug.
• People who are pregnant or breastfeeding.
• People whom the treating doctor considers unsuitable for the trial for any other reason.

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