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 been confirmed through laboratory testing to have locally advanced or metastatic non-small cell lung cancer (stage IIIB or IV) that is not the squamous cell type.
• People who have one or more tumour lesions that can be measured using standard imaging criteria (RECIST version 1.1), including lesions in previously treated radiation areas if those lesions have grown.
• People whose tumour has been confirmed to have a specific gene change (EGFR mutation — either an exon 19 deletion or L858R) identified by an accredited institution.
• People with a history of smoking, including current smokers, defined as having smoked more than 100 cigarettes total in their lifetime.
• People with a general health status rated as ECOG 0 or 1 — meaning fully active or able to carry out light work (confirm with trial site).
• People whose blood cell counts meet minimum levels: white blood cells (ANC) at least 1,500/uL, haemoglobin at least 9.0 g/dL, and platelets at least 100,000/uL.
• People whose liver function test results fall within acceptable ranges for bilirubin, AST, and ALT, with slightly higher limits allowed if liver involvement is present (confirm with trial site).
• People whose kidneys are functioning adequately, as measured by creatinine levels or a calculated kidney clearance rate of at least 50 mL/min, and whose urine protein levels are within acceptable limits.
• People who have had radiation therapy must have waited the required time before joining: at least 12 weeks if radiation was directed at the lung or chest bone area, or at least 2 weeks if radiation was to any area outside the chest.
• People who have completed certain prior medical procedures must have waited the required time: at least 4 weeks after surgery, 1 week after tissue biopsy, 2 weeks after blood transfusion or wound treatment, and 4 weeks after finishing another clinical trial medication (other timeframes apply — confirm with trial site).
• Women of childbearing potential must have a negative pregnancy test (blood or urine) within 7 days before starting treatment.
• Male participants and female participants of childbearing potential must agree to use two approved methods of contraception for at least 180 days after the last dose, and women in the bevacizumab group are asked to discuss fertility preservation before starting treatment.
• People who have given written consent to participate in the clinical trial.

Who may not be able to join:

• People who have had another cancer (other than lung cancer) within the past 3 years, except for certain treated cancers such as cervical epithelial cancer, basal or squamous cell skin cancer, thyroid cancer, or localised prostate cancer treated with curative surgery.
• People who have had a significant bleeding episode (Grade 2 or above, involving bright red blood of 2.5 mL or more) within the 3 months before joining.
• People who have previously received chemotherapy or other systemic anti-cancer treatments (including targeted therapies or monoclonal antibodies) for advanced lung cancer — though chemotherapy completed more than 6 months before joining as part of pre- or post-surgery treatment may be allowed.
• People whose scans show that the tumour has grown into or is invading major blood vessels such as the pulmonary artery.
• People who are scheduled to have any surgical procedure (including insertion of a drain or catheter) within 24 hours of the first bevacizumab dose.
• People who have recently used or are currently using aspirin above 325 mg/day, or injectable or oral blood-thinning or clot-dissolving medications for treatment purposes, within 10 days before the first bevacizumab dose (preventive use of anticoagulants may be allowed — confirm with trial site).
• People who are currently taking, or cannot stop taking before starting lazertinib, strong CYP3A4-inducing medications or herbal supplements (these are substances that affect how the body processes certain drugs — confirm with trial site).
• People who have any evidence of a lung condition called interstitial lung disease (ILD), whether current or historical, including radiation-related lung inflammation that required steroid treatment.
• People who are currently receiving or are likely to receive bisphosphonate medications (a type of bone-strengthening drug).
• People with brain or spinal metastases that are not well controlled — though those whose brain metastases are stable, without symptoms, and not requiring steroids may still be considered.
• People with significant eye surface problems such as corneal ulcers, perforations, or active eye inflammation with symptoms including pain, tearing, blurred vision, or bleeding.
• People with a personal or inherited history of blood clotting disorders or a high risk of bleeding.
• People with uncontrolled high blood pressure (systolic above 150 mmHg and/or diastolic above 100 mmHg).
• People with significant active heart or blood vessel conditions within the past 6 months, such as stroke, heart attack, unstable chest pain, moderate-to-severe heart failure, blood clots, or serious irregular heart rhythms.
• People whose heart electrical activity (ECG) shows a corrected QT interval above 470 milliseconds, significant rhythm or conduction abnormalities, or other factors that increase the risk of dangerous heart rhythm problems.
• People with wounds that are not healing, active stomach or intestinal ulcers, or fractures.
• People with active infections or uncontrolled serious systemic illnesses.
• People with a known allergy or hypersensitivity to lazertinib, bevacizumab, or any of their ingredients, including similar drugs in the same class.
• People with a known hypersensitivity to products derived from Chinese hamster ovary (CHO) cells, or to other recombinant human or humanised antibody products.
• Women who are pregnant or breastfeeding.

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