Phase 1b/2 Study of AK104 (Anti-PD1/CTLA4 Bispecific Antibody) in Combination With Etoposide and Carboplatin Plus Low-dose Radiotherapy (LDRT) for the First-line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Phase Ib/II, open-label, multicentre study to evaluate the efficacy and safety of low-dose radiotherapy (LDRT) combined with AK104 and chemotherapy as first-line treatment for patients with ES-SCLC.
• 18 to 80 years old.
• Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
• Histologically or cytologically confirmed diagnosis of ES-SCLC per the Veterans Administration Lung Study Group (VALG) staging system.
• No prior treatment for ES-SCLC.
• Measurable disease, as defined by RECIST v1.1.
• Eastern Cooperative Oncology Group performance status ≤ 1.
• Life expectancy ≥ 3 months.
• Adequate hematologic and end-organ function.
• All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.