CTLA-4 inhibition

The key inclusion criteria^1,2 are –

• Histological or cytological evidence of LS-SCLC (Stage I-III); Stage I-II must be medically inoperable
• WHO or ECOG PS 0 or 1
• Received 4 cycles of chemotherapy containing platinum and IV etoposide concurrent with radiotherapy administered as per local standard of care regimens, completed within 1-42 days prior to randomization and first dose of IP
• Received a total dose of radiation of 60 to 66 Gy over 6 weeks for standard once-daily radiation schedules or 45 Gy over 3 weeks for hyperfractionated twice-daily radiation
• RT must have commenced no later than the end of cycle 2 of chemotherapy
• Three cycles of platinum-based cCRT will be permitted if disease control was achieved and no additional benefit is expected with an additional cycle of chemotherapy in the opinion of the investigator
• Achieved CR, PR or SD and did not progress following definitive platinum-based cCRT
• PCI may be delivered per investigator’s discretion and local standard of care, and must be conducted after the end of cCRT and completed 1–42 days before first dose of IP
• Availability of tumor tissue
• Estimated life expectancy of ≥12 weeks

References:

1. Study NCT03703297. ClinicalTrials.gov website.

2. Cheng Y, et al. Protocol. N Engl J Med. 2024;391(14):1313-1327.

The key exclusion criteria^1,2 are –

• Extensive-stage SCLC or mixed SCLC and NSCLC histology
• Patients with any history of Grade ≥2 pneumonitis
• Active or prior documented autoimmune or inflammatory disorders or uncontrolled intercurrent illness
• History of another primary malignancy, leptomeningeal carcinomatosis or primary immunodeficiency, or active infection
• Any unresolved toxicity (CTCAE Grade ≥2) from prior chemoradiotherapy
• Receipt of chemotherapy that exceeds 4 cycles in total. Chemotherapy regimens other than etoposide and platinum are not permitted.
• Received sequential chemotherapy and radiotherapy for LS-SCLC (no overlap of RT with chemotherapy)
• Disease progression while on cCRT