New hope for tough lung cancer: ALPS12 drug trial begins

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged \>18 years at time of informed consent * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 * Histologically documented extensive stage small cell lung cancer * Disease recurrence documented after at least one prior systemic therapy. * Confirmed availability of representative archival tumor specimens or fresh tumor specimen. * Measurable disease per RECIST v.1.1. * Adequate hematologic and end organ function Exclusion Criteria: * Pregnant or breastfeeding, or intending to become pregnant or breastfeeding during the study * History or complication of clinically significant autoimmune disease * a positive HIV antibody test at screening * Active hepatitis B or hepatitis C * Prior treatment with anti-CD137 antibody drugs, anti-CD3 antibody drugs, and/or DLL3-targeted therapies * Patients who have received any investigational or approved anticancer therapy, including hormone therapy and/or radiotherapy, within 21 days prior to the first administration of the investigational drug. * History of Grade 4 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase) * Patients who discontinued immunotherapy due to Grade 3 immune-related adverse events caused by prior anti-PD-L1/PD-1 antibody drugs or anti-CTLA-4 antibody drugs (excluding asymptomatic elevations in serum amylase/lipase), and/or patients who experienced Grade 3 immune-related adverse events caused by immunotherapy within 6 months prior to the first administration of the investigational drug * Patients who received a live attenuated vaccine within 4 weeks prior to the first administration of the investigational drug * History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti tumor treatment, or leptomeningeal disease * Current or past CNS diseases (e.g., stroke, epilepsy, CNS vasculitis, neurodegenerative diseases)