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 aged 18 to 75 years old (inclusive) at the time of signing the consent form, of any gender.
• People diagnosed with a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that is advanced (stage IIIB or IIIC), has spread to other parts of the body, or has come back — and where surgery or combined radiation and chemotherapy are not suitable options.
• People whose lung cancer has tested positive for certain genetic changes (called driver gene mutations), including specific changes in EGFR, ALK, ROS1, BRAF, NTRK, MET, RET, KRAS, or HER-2 genes (confirm with trial site for full list).
• People whose previous targeted therapy treatment has stopped working and for whom no other standard targeted treatment is currently available.
• For one group (Cohort 1): people whose cancer has tested positive for a protein called PD-L1 (TPS ≥ 1%), confirmed by a laboratory. For another group (Cohort 2): people able to provide a tissue sample for biomarker testing at a central laboratory.
• People who can provide a valid test report confirming the genetic change in their cancer, or who agree to provide a sample for that testing.
• People who have at least one measurable tumour site, as assessed using standard measurement guidelines (RECIST v1.1).
• People with a general health and activity level scored at 0 or 1 on a standard medical scale (meaning they are fully active or have only minor limitations in physical activity).
• People with an expected survival of at least 12 weeks.
• People whose major organ functions (such as liver, kidneys, and blood) meet the health levels required by the trial.
• People who agree to use effective contraception for a specified period after their last dose of the trial drugs, and who are not pregnant or breastfeeding (confirm with trial site for specific timeframes based on assigned treatment).
• People who voluntarily agree to participate, sign a consent form, and are willing to attend follow-up appointments.

Who may not be able to join:

• People whose tumour contains certain other cancer cell types, such as small cell lung cancer or squamous cell carcinoma components above 10%, or who have cancer spread to the membranes around the brain, active brain metastases with symptoms, or tumours near major blood vessels or with signs of significant breakdown that the doctor considers a bleeding risk.
• People who have previously received certain treatments, including immune-based therapies, systemic chemotherapy, or specific targeted or antibody-drug treatments (the restriction on some of these applies only to Cohort 2 — confirm with trial site).
• People with a significant tendency to bleed or a history of serious blood clotting problems.
• People who experienced a bowel perforation, internal fistula, or internal abscess within the 6 months before starting the trial, or who currently have conditions the doctor considers high risk for these occurring.
• People with a serious wound that has not healed, an active ulcer, or an untreated broken bone.
• People with uncontrolled high blood pressure, or a history of hypertensive crisis or high-blood-pressure-related brain complications.
• People whose side effects from previous cancer treatment have not sufficiently recovered (must be at grade 1 or lower on a standard side effect scale).
• People with a known allergy to the trial drugs or their ingredients, to pemetrexed, or to platinum-based chemotherapy drugs (carboplatin or cisplatin), or who have had a severe (grade 3 or higher) allergic reaction to an antibody-based drug in the past.
• People with an active autoimmune disease or a history of autoimmune disease.
• People with a history of immune system deficiency.
• People who have had a serious infection within the 4 weeks before starting the trial.
• People with a confirmed or suspected history of certain lung conditions, including interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced lung inflammation, or other moderate to severe lung diseases that significantly affect lung function.
• People with active tuberculosis detected through their medical history or a chest scan.
• People with active tuberculosis, hepatitis B, or hepatitis C.
• People who have been diagnosed with any other type of cancer within the 5 years before starting the trial.
• People with certain other uncontrolled medical conditions listed in the trial protocol (confirm with trial site).
• People who, in the doctor's judgement, have other serious medical or mental health conditions, or significant abnormal test results, that could increase risk or affect the trial's results.

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