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 able to give written consent to participate and agree to follow the study requirements
• People who have been diagnosed with metastatic or locally advanced non-squamous non-small cell lung cancer
• People who have not previously received treatment for locally advanced or metastatic non-small cell lung cancer, or who received adjuvant (preventative) therapy more than 12 months before joining
• People who are older than 18 years at the time of joining the study
• People who have a good general physical functioning level, rated 0 or 1 on a standard medical scale (ECOG), meaning they are fully active or have only mild restrictions
• People whose life expectancy is at least 6 months
• People whose tumour tests show a PD-L1 score below 50% (a measure of a protein linked to cancer immune response)
• People who have at least one tumour that can be measured using standard imaging scans
• People who weigh more than 30 kg
• People whose heart, liver, kidney, and blood test results meet the required healthy ranges set by the trial
• People whose heart function tests show a normal electrical pattern (QTc below 450ms) and a pumping function of at least 50%
• People who are willing and able to attend all scheduled visits and treatment sessions for the full duration of the study
• People who are covered by a social security scheme or equivalent (confirm with trial site, as this criterion may apply specifically in France)
• People whose tumour tissue sample meets the required quality and quantity standards, either from a sample taken less than one month ago or a new biopsy
• People who are willing to have tumour biopsies taken as required by the study (4 samples at the start, and additional samples at set timepoints depending on the study phase)

Who may not be able to join:

• People who have taken part in another clinical trial involving an experimental treatment in the past 2 months
• People currently enrolled in another interventional clinical trial (observational studies or completed follow-up periods may be exceptions)
• People whose cancer has specific gene changes known as EGFR, ROS, or ALK mutations
• People who still have unresolved side effects rated grade 2 or higher from previous cancer treatment (with some exceptions such as hair loss, skin colour changes, or hearing-related effects)
• People who are currently receiving other cancer treatments such as chemotherapy, biological therapy, or hormonal cancer therapy
• People who have had major surgery within 28 days before starting the study treatment
• People who have digestive system conditions that could affect how oral medications are absorbed, such as severe nausea, vomiting, diarrhoea, or malabsorption
• People who have had an organ, bone marrow, or umbilical cord blood transplant from another person
• People with active or previously documented autoimmune or inflammatory conditions (such as Crohn's disease, lupus, rheumatoid arthritis, or similar), with some exceptions including stable thyroid conditions on medication, vitiligo, alopecia, skin conditions not needing systemic treatment, celiac disease managed by diet, or conditions with no active disease in the past 5 years (with doctor review)
• People with a history of glaucoma, certain eye conditions affecting the retina, or risk factors for retinal vein blockage such as high eye pressure or uncontrolled blood sugar
• People with serious uncontrolled medical conditions, including active infections, uncontrolled high blood pressure, unstable heart conditions, certain lung diseases, severe gastrointestinal conditions, spinal cord compression, or psychiatric conditions that would affect their ability to participate safely
• People currently taking medications known to affect the heart's electrical rhythm in a specific way (QT interval prolongation)
• People whose resting heart trace (ECG) shows uncontrolled or potentially reversible heart conditions, or people with a hereditary condition called long QT syndrome
• People with or showing signs of certain blood disorders (myelodysplastic syndrome or acute myeloid leukaemia)
• People with a history of another cancer, unless it was treated with the intent to cure, has shown no signs of returning for at least 5 years, and carries a low risk of coming back — certain treated skin cancers and pre-cancerous conditions with no current signs of disease may be exceptions
• People with a history of cancer spreading to the membranes surrounding the brain or spinal cord
• People with active, symptomatic cancer spread to the brain or central nervous system
• People with a known primary immune deficiency or a known positive HIV status
• People with active infections including tuberculosis, active hepatitis B, active hepatitis C, or HIV (some people with past resolved hepatitis B or hepatitis C infections may still be eligible — confirm with trial site)
• People who have taken immunosuppressive medications within 14 days before the first dose (with exceptions for low-dose or inhaled/topical steroids)
• People who have received a live or live-attenuated vaccine within 30 days before starting treatment
• People who are pregnant or breastfeeding
• People of reproductive capacity who are not willing to use effective contraception from the screening period until 180 days after the last dose of treatment
• People with a known allergy or sensitivity to any of the study drugs or their ingredients

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