A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC

Korábbi kezelés

• Significant cardiovascular disease within 3 months prior to enrollment
• Any concurrent chemotherapy, study intervention, biologic, or hormonal therapy for cancer treatment.
• Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention.

Más betegség

• History of another primary malignancy
• Presence or history of Central Nervous System (CNS) metastases
• History of allogeneic organ transplantation.
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest CT scan.

Egyéb

• Clinically confirmed leptomeningeal carcinomatosis.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the last dose of study intervention.

• Participant has histologically or cytologically confirmed ES-SCLC (per Veterans Administration Lung Study Group staging system).
• Participant has received 4 cycles of definitive platinum-based chemotherapy with at least 3 cycles of durvalumab
• Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Must have a life expectancy of ≥ 12 weeks as assessed by the treating physician.
• Adequate hematologic and end-organ function for at least 7 days prior to dosing.
• Has a body weight > 30 kg.
• Adequate contraceptive precautions.