Phase II Clinical Trial of Durvalumab (MEDI4736) and Lurbinectedin in Patients With Relapsed Extensive Stage Small Cell Lung Cancer Previously Treated With Chemotherapy and Immunotherapy
This phase II trial studies the effects of durvalumab and lurbinectedin in treating patients with extensive stage small cell lung cancer that has come back (relapsed) or has not responded to previous treatment with chemotherapy and immunotherapy (refractory). Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Lurbinectedin is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in the body. Giving durvalumab and lurbinectedin may help kill more tumor cells and help patients live longer.
• Age \>= 18 years
• Histological or cytological confirmation of small cell lung cancer
• Prior treatment requirements:
‣ Relapsed or progressed after only one prior chemotherapy and PD-1 or PD-L1 inhibitor regimen
⁃ Prior therapy must have been an etoposide platinum doublet combined with PD-1 or PD-L1 inhibitor
⁃ Group 1: Must have platinum-sensitive disease according to the following definitions:
• Sensitive disease: Relapse occurred \> 90 days after completion of prior therapy
∙ Resistant Disease: Relapse occurred =\< 90 days after completion of prior therapy
⁃ Group 2: May have platinum-sensitive (Group 2A) or platinumresistant (Group 2B) disease
• Measurable disease
• Body weight \> 30 kg
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Hemoglobin \>= 9.0 g/dL (obtained =\< 15 days prior to registration)
• Absolute neutrophil count (ANC) \>= 1500/mm\^3 (obtained =\< 15 days prior to registration)
• Platelet count \>= 100,000/mm\^3 (obtained =\< 15 days prior to registration)
• Albumin \>= 2.5 mg/dL (obtained =\< 15 days prior to registration)
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) or direct bilirubin =\< ULN if total bilirubin is \> 1.5 x ULN (obtained =\< 15 days prior to registration)
• Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\< 2.5 x ULN (=\< 5 x ULN for patients with liver involvement) (obtained =\< 15 days prior to registration)
• Creatinine OR glomerular filtration rate (GFR) =\< 1.5 x ULN OR glomerular filtration rate (GFR) \> 60 mL/min for patients with creatinine \> 1.5 x ULN (obtained =\< 15 days prior to registration)
• Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
• Persons able to become pregnant OR able to father a child must be willing to use an adequate method of contraception while on treatment and for 120 days after last treatment
• Life expectancy \>= 12 weeks
• Provide written informed consent
• Willingness to provide mandatory blood specimens for correlative research
• Willingness to provide mandatory tissue specimens for correlative research
• Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study)