Phase 3 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 aged 18 to 75 years at the time of signing the consent form, of any gender
• People diagnosed (through tissue or cell testing) with a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that is either locally advanced (stage IIIB or IIIC) or has spread to other parts of the body (stage IV), and is not suitable for surgery or full-course radiotherapy
• People who have not yet received any systemic (whole-body) drug treatment for their locally advanced or metastatic lung cancer
• People whose lung cancer has been confirmed (through tissue or cell testing) to have specific gene changes called EGFR-sensitive mutations
• People who have tumor tissue samples available from when their advanced or metastatic cancer was diagnosed or after
• People who have at least one measurable area of cancer that doctors can track using standard imaging guidelines
• People who are generally well enough to carry out light activity, based on a standard health rating scale assessed within 7 days before joining the trial
• People whose life expectancy is at least 12 weeks
• People whose organs (such as kidneys and liver) and bone marrow are functioning adequately

Who may not be able to join:

• People whose lung cancer includes small cell lung cancer, certain rare cancer types (neuroendocrine carcinoma or carcinosarcoma), or more than 10% squamous cell carcinoma, confirmed through tissue or cell testing
• People who have already received systemic drug treatment for locally advanced or metastatic NSCLC
• People who have previously received a therapy targeting a protein called TROP2, or any drug (including certain antibody-drug treatments) that targets an enzyme called topoisomerase I — including as part of earlier pre- or post-surgery treatment
• People with known cancer spread to the membranes around the brain, the brainstem, the spinal cord, or with active or symptomatic cancer spread to the brain or central nervous system
• People who have had another cancer within the past 3 years before joining the trial
• People with clinically significant abnormalities on a resting heart tracing (ECG)
• People with certain heart or blood vessel conditions, or known risk factors for these conditions (confirm with trial site for specifics)
• People with a history of scarring or inflammation of the lung tissue (interstitial lung disease), lung inflammation caused by medication, or lung inflammation that previously required steroid treatment, or who currently have these conditions
• People with clinically serious lung damage caused by existing lung disease
• People who still have unresolved side effects from previous cancer treatment that are above a mild level (confirm with trial site for specifics)
• People who have been taking steroid tablets (such as prednisone) at more than 10 mg per day, or other immune-suppressing medicines, within the 2 weeks before joining the trial
• People with known active tuberculosis affecting the lungs
• People who have previously had an organ transplant or bone marrow/stem cell transplant from another person
• People with active hepatitis B or hepatitis C infection
• People who test positive for HIV or have a history of AIDS, or who have a known active syphilis infection
• People with a known allergy to the study drugs (osimertinib or SKB264) or any of their ingredients, or who have had a serious allergic reaction to similar biological medicines
• People who have received a live vaccine within 30 days before joining the trial, or who plan to receive one during the study
• Women who are pregnant or currently breastfeeding
• People with significant non-cancer-related illnesses or conditions, or serious symptoms caused by the tumor itself (confirm with trial site for specifics)

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