Personalized Neoantigen Vaccine with Durvalumab for Extensive Stage Small Cell Lung Cancer

Inclusion Criteria

• Diagnosed with extensive stage small cell lung cancer (ES-SCLC).
• Suitable for first-line treatment with platinum-based chemotherapy and durvalumab.
• Have at least one tumor that can be measured and biopsied.
• Aged 18 years or older.
• Good overall health with a performance status of 0 or 1.
• Expected to live at least 12 more weeks.
• Weigh more than 30 kg.
• Have normal organ and bone marrow function, including:
  • Hemoglobin of at least 9.0 g/dL.
  • Neutrophil count of at least 1.0 K/cumm.
  • Platelet count of at least 75 K/cumm.
  • Normal liver and kidney function.
• Heart function within normal limits.
• Oxygen levels in the blood above 92%.
• Women must not be pregnant and must have a negative pregnancy test if pre-menopausal.
• Agree to use effective birth control during the study and for 90 days after the last dose of durvalumab.
• Able to understand and sign a consent form, including consent for genetic testing and data sharing.

Exclusion Criteria

• Previous treatment with PD-1 or PD-L1 inhibitors.
• History of another cancer unless treated and inactive for at least 5 years.
• Currently taking other experimental drugs.
• Enrolled in another clinical trial, unless it's observational.
• Previous participation in a durvalumab study.
• Unresolved side effects from past cancer treatments, except for hair loss and skin changes.
• Recent major surgery or radiation affecting a large area.
• History of organ transplant or certain brain conditions.
• Allergies to durvalumab or similar drugs.
• Uncontrolled health issues, such as infections or heart problems.
• Use of immunosuppressive drugs recently.
• Recent live vaccine.
• Fewer than two suitable sites for injections.
• Metal implants at injection sites.
• Conditions that prevent injections or blood draws.
• Neurological disorders, except for a single childhood seizure.
• Use of electronic devices like pacemakers.
• Autoimmune or inflammatory disorders, with some exceptions.
• Pregnant or breastfeeding women.
• Active infections like tuberculosis, hepatitis, or HIV.