Study on Chemo-Immunotherapy Followed by Durvalumab and Ceralasertib for Newly Diagnosed Extensive Stage Small Cell Lung Cancer

Inclusion Criteria

• Must provide written consent and agree to share personal health information.
• Be 18 years or older.
• Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Have a confirmed diagnosis of small cell lung cancer that is extensive stage.
• Be suitable to receive a first-line chemotherapy treatment that includes either Carboplatin or Cisplatin with Etoposide.
• Have measurable cancer according to specific criteria within 28 days before joining the study.
• Have completed any prior radiation treatment for painful bone lesions or whole brain radiation at least 14 days before starting the study, and be off steroids without worsening brain symptoms.
• Have adequate organ function as shown by specific blood tests:
  • Neutrophil count of at least 1500/mm³
  • Platelet count of at least 100,000/mm³
  • Hemoglobin level of at least 9 g/dL
  • Creatinine level within normal limits or creatinine clearance of at least 50 mL/min
  • Liver function tests within specified limits
• Women of childbearing potential and men who are sexually active must agree to use effective contraception during the study and for 6 months after the last dose.
• Women must have a negative pregnancy test or be post-menopausal.
• Must be able to understand and comply with study procedures.
• Must be able to swallow and retain oral medication.
• Must have a life expectancy of at least 12 weeks.

Exclusion Criteria

• Have received prior treatment for extensive stage or recurrent small cell lung cancer.
• Have a significant active infection requiring treatment.
• Be pregnant or breastfeeding.
• Have had major surgery within 28 days before starting the study.
• Be currently receiving other investigational treatments.
• Have another active cancer requiring treatment, except for certain non-threatening types.
• Have an immune deficiency or be on high-dose steroids or other immunosuppressive therapy.
• Have active autoimmune or inflammatory disorders, with some exceptions.
• Have a history of immune therapy-related lung inflammation requiring steroids.
• Have untreated or symptomatic brain metastases.
• Have a history of hepatitis B, hepatitis C, or HIV, unless under control.
• Have active tuberculosis.
• Have had a stem cell or organ transplant.
• Have uncontrolled illnesses like heart failure, unstable angina, or psychiatric conditions.
• Have allergies to study drugs.
• Have received live vaccines within 4 weeks of starting the study.
• Have conditions affecting the absorption of oral medication.
• Weigh 30 kg or less.
• Be taking medications that strongly affect liver enzymes, unless a wash-out period is observed.