Neoadjuvant Sacituzumab Govitecan Plus Pembrolizumab in Resectable Non-Small Cell Lung Cancer

Exclusion Criteria

• •1. Presence of any distant metastasis
• •3. Received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment Day 1
• •4. Mixed SCLC and NSCLC histology
• •5. Any previous treatment with a PD-1 or PD-L1 or CTLA4 inhibitor, or another agent directed to stimulatory or coinhibitory T-cell receptor (OX40, CD137, etc)
• •6. Any previous treatment with sacituzumab govitecan, topoisomerase inhibitor, or TROP-2 targeted therapy.
• •7. Previous radiotherapy to the chest including radiation to mediastinal tumours (e.g. germ cell tumours and thymic tumours)
• •8. Positive pregnancy test by urine or serum (Appendix V) or women who are breastfeeding
• •9. Known hypersensitivity to pembrolizumab or Sacituzumab govitecan, or their metabolites or formulation excipient
• •10. Requirement for ongoing therapy with or prior use of any prohibited medications listed in Appendix IV
• •11. Absolute contraindications for the use of corticosteroids as premedication
• •12. Concurrent treatment with other experimental drugs or other anticancer therapy, treatment in a clinical trial within 30 days prior to registration
• •13. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment
• •14. Current or prior use of immunosuppressive medication within 28 days before the first dose of pembrolizumab or sacituzumab govitecan, with the exceptions of intranasal and inhaled corticosteroid or systemic corticosteroids at physiological doses (i.e. which must not exceed 10mg/day of prednisone or an equivalent corticosteroid) and the premedication for chemotherapy.
• •15. Severe or uncontrolled cardiac disease, congestive heart failure NYHA class III or IV, unstable angina pectoris, history of myocardial infarction during the last 3 months, serious arrhythmias requiring medication (with the exception of atrial fibrillation or paroxysmal supraventricular tachycardia under medical control); history of QTc interval prolongation
• •16. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illness including, but not limited to, any underlying pulmonary disorder (ie pulmonary embolism within 3 months of enrolment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.); history of (non-infectious) pneumonitis that required steroids or recurrent pneumonitis; any autoimmune/connective tissue/inflammatory disorders with pulmonary involvement, or prior pneumonectomy.
• •17. Active autoimmune disease requiring systemic treatment within the past 2 years or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents with the exception of resolved childhood asthma/atopy, hypothyroidism or adrenal insufficiency on hormone replacement, diabetes mellitus stable on insulin replacement
• •18. Active HBV or HCV infection
• •19. Known history of Human Immunodeficiency Virus (HIV).
• •20. History of primary immunodeficiency
• •21. History of allogeneic organ transplant
• •22. Receipt of live attenuated vaccination any time during trial therapy and within 30 days of receiving the last dose of trial therapy. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed. COVID-vaccination is allowed.
• •23. Any concomitant drugs contraindicated for use with pembrolizumab or sacituzumab govitecan including systemic corticosteroid, methotrexate, azathioprine, TNF-alpha blockers.
• •24. Any other serious underlying medical, psychiatric, psychological, familial condition that in the judgement of the investigator, that may interfere with planned staging, treatment and follow up, affect patient compliance, or place the patient at high risk from treatment-related complications.
• •25. Patients who refuse surgical treatment of the lung cancer