Phase 3 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 diagnosed with advanced non-squamous non-small cell lung cancer (a specific type of lung cancer) that has spread to other parts of the body, confirmed by a tissue or cell sample, and cannot be treated with surgery or a combination of radiation and chemotherapy at the same time.
• People whose cancer has been staged as Stage IIIa through IVb (advanced stages) using a standard international lung cancer staging system.
• People whose lung cancer has two specific genetic changes: a mutation in the EGFR gene and a mutation in the TP53 gene.
• People who have not previously received chemotherapy or radiation therapy for their cancer, or whose cancer returned more than 6 months after completing earlier preventive (adjuvant) chemotherapy.
• People who have at least one measurable tumour, as assessed using standard medical imaging guidelines.
• Adults aged between 18 and 75 years.
• People with a good general health and ability to carry out daily activities, as measured by a standard scoring system (confirm with trial site).
• People whose life expectancy is at least 12 weeks.
• People whose blood counts and blood chemistry results meet specific minimum levels — including white blood cells, platelets, and haemoglobin (confirm with trial site for exact values).
• People whose liver function test results are within acceptable ranges (confirm with trial site for exact values).
• People whose kidney function results are within acceptable ranges (confirm with trial site for exact values).
• People who have had previous surgery and have had at least 4 weeks of recovery before joining the trial.
• Women with a uterus who have a negative pregnancy test within 28 days before joining the trial, with an additional urine pregnancy test required within 7 days before the first dose if the earlier test was more than 7 days prior.
• People of any gender who agree to use highly effective contraception (less than 1% annual failure rate) throughout the treatment period and for 120 days after the last dose.
• People who are willing and able to give informed consent and follow the trial requirements.

Who may not be able to join:

• People with a known allergy to either of the study drugs (almonertinib or anlotinib) or any of their ingredients.
• People who cannot tolerate the study drugs or who are allergic to any ingredients in the chemotherapy drugs used in this trial.
• Women who are pregnant, breastfeeding, or who may become pregnant and are unwilling to use appropriate contraception.
• People with a severe active infection that is not currently under control, or a long-lasting infection with a wound that is not healing.
• People with serious pre-existing heart conditions, including heart failure, uncontrolled dangerous heart rhythm problems, unstable chest pain, a previous heart attack, severe heart valve disease, or blood pressure that cannot be controlled with treatment.
• People with uncontrolled mental health or neurological conditions that would make it difficult to cooperate with the trial, or people with brain tumours or cancer that has spread to the brain in a way that is causing uncontrolled symptoms.
• People with inherited bleeding disorders, problems with blood clotting, a history of blood clots or serious bleeding, or abnormal blood clotting test results.
• People currently receiving treatment to dissolve or prevent blood clots due to a high risk of clotting.
• People with wounds, ulcers, or bone fractures that have not fully healed.
• People currently taking part in another clinical trial, or who have received an experimental drug or used an experimental medical device within 4 weeks before the first dose.
• People who have had major surgery within 4 weeks before starting the trial, or who are expected to need major surgery during the trial (minor procedures such as biopsies may be acceptable — confirm with trial site).
• People with a lung condition called pulmonary interstitial fibrosis that has led to breathing failure.
• People with chronic obstructive pulmonary disease (COPD) that has led to breathing failure.
• People with active tuberculosis affecting the lungs.
• People with an active autoimmune disease that has required ongoing medical treatment (such as immune-suppressing drugs or steroids) within the 2 years before the first dose — note that simple hormone replacement therapies such as thyroid medication are not considered to fall under this exclusion (confirm with trial site).
• People currently receiving steroid tablets or injections (not including nasal sprays, inhalers, or creams) or any other immune-suppressing treatment within 14 days before the first dose.
• People whom the trial investigators consider unsuitable for participation for other medical reasons.

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