Study on the Safety and Effectiveness of Combining APL-101 with Osimertinib for Patients with EGFR-mutated Metastatic Non-small Cell Lung Cancer

Inclusion Criteria

• Have a confirmed diagnosis of metastatic non-small cell lung cancer with a specific EGFR mutation.
• Have at least one tumor that can be measured and biopsied.
• Be planning to start treatment with osimertinib and have been on it for 8 to 16 weeks without the cancer worsening.
• Be at least 18 years old.
• Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have normal blood and organ function based on specific lab tests.
• Agree to use effective birth control during the study and inform the doctor immediately if pregnancy is suspected.
• Be able to understand and sign a consent form to participate in the study.

Exclusion Criteria

• Have previously been treated with osimertinib for metastatic cancer, except for the period immediately before and during enrollment.
• Have received immunotherapy or EGFR-targeted treatment for metastatic cancer.
• Have cancer that does not respond to osimertinib.
• Have a history of other cancers, unless they were treated over a year ago and are not currently active.
• Be taking other experimental drugs or herbal supplements.
• Have untreated or unstable brain metastases.
• Have allergies to similar drugs used in the study.
• Have uncontrolled health conditions like infections, heart problems, or diabetes.
• Have fluid buildup around the lungs or heart that is not controlled.
• Have had major surgery within 30 days before starting the study treatment.
• Have severe digestive issues like diarrhea or nausea.
• Be pregnant or breastfeeding, and women must have a negative pregnancy test before starting the study.
• Have unresolved side effects from previous treatments, unless they are being managed and are not expected to interfere with the study.