Global Study Comparing AMT-116 with Standard Treatment for Advanced Non-Small Cell Lung Cancer

Inclusion Criteria

• Agree to participate in the study and follow all procedures, including hospital visits and tests.
• Aged between 18 and 80 years.
• Diagnosed with advanced non-squamous non-small cell lung cancer (NSCLC) that cannot be surgically removed or has spread.
• Have a clear test result for the EGFR gene and may have other gene mutations.
• Have received no more than one line of chemotherapy for advanced cancer.
• Have had at least one prior treatment for advanced cancer, with disease progression or recurrence.
• Suitable for docetaxel treatment (Phase 3 only).
• Have at least one measurable tumor.
• Be in good physical health with a performance status score of 0 or 1.
• Expected to live at least 12 more weeks.
• Have normal organ function and meet specific blood test criteria.
• Women of childbearing age must use effective contraception and have a negative pregnancy test before joining.
• Men must use condoms during treatment and for 12 weeks after the last dose.

Exclusion Criteria

• Previous treatment with certain antibody-drug conjugates.
• Recent systemic anti-cancer therapy within a specified time before joining.
• Certain types of lung cancer or gene mutations.
• Cancer that can be treated with local therapy alone.
• Untreated or unstable brain metastases.
• Unresolved side effects from previous cancer treatments.
• Recent wide-field radiation or major surgery.
• Severe heart conditions or uncontrolled health issues.
• History of lung diseases or recent blood clots.
• Active infections like hepatitis or HIV.
• Recent live vaccine or certain medications.
• Allergies to study drugs or components.
• Substance abuse or mental health issues affecting consent.
• Recent history of other cancers, with some exceptions.
• Specific exclusions for Phase 3, including prior docetaxel treatment and certain medical conditions.