Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer

Exclusion Criteria

• •1. Previous treatment with lurbinectedin,
• •2. Current or prior use of immunosuppressive medication including any use of oral glucocorticoids, within 14 days before the first dose of durvalumab,
• •3. Active or prior documented inflammatory bowel disease,
• •4. Has an active autoimmune disease requiring systemic treatment within the past 2 years,
• •5. Has evidence of active non-infectious pneumonitis,
• •6. Has an active or ongoing infection requiring systemic therapy,
• •7. Currently active bacterial or fungus infection, HIV1, HIV2, hepatitis A or hepatitis B or hepatitis C infections,
• •8. Symptomatic untreated, or steroid-requiring, or progressing central nervous system malignancy is excluded.
• •9. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding,
• •10. Previous enrolment in the present study,
• •11. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
• •12. Has received a live vaccine within 30 days prior to the first dose of trial treatment,
• •13. Known hypersensitivity to any involved study drug or any of its formulation components,
• •14. Tumors not accessible for biopsy,
• •15. Active infection including tuberculosis,
• •16. Person under judicial protection or deprived of liberty,
• •17. Concomitant use of strong inhibitors or inductors of cytochrome CYP3A4 taken within 21 days prior to the first dose of study drug,
• •18. Uncontrolled symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, clinically significant valvular heart disease,
• •19. Intermittent or continuous oxygen requirement,
• •20. Presence of any external drainage,
• •21. Known myopathy,
• •22. Concomitant administration of any other antineoplastic therapy, other investigational agents, immunosuppressive therapies, Aprepitan or any other NK-1 antagonist,
• •23. Major surgical procedure within 28 days prior to the first dose of durvalumab.
• •24. History of allogenic organ transplantation,
• •25. History of leptomeningeal carcinomatosis,
• •26. QT interval corrected for heart rate using Fridericia's formula ≥470 ms