Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC
The purpose of this study is to test whether or not number of circulating cancer cells detected in the blood can be decreased the by combining the standard treatment (durvalumab) with Tremelimumab and additional chemotherapy
• Histologically- or cytologically-documented NSCLC presenting with locally-advanced, unresectable stage III disease (Version 8 of AJCC Staging Manual) or NSCLC with locoregional recurrence after previous definitive treatment.
• For stage III or recurrent disease, must have completed platinum-based chemotherapy and radiation therapy to all known tumor sites (60 Gy +/- 10%). Must not have known progression of disease.
• Must be receiving consolidation durvalumab following completion of radiation and chemotherapy, and less than 32 weeks has elapsed from their first dose of durvalumab. (Patients may sign consent for study before start of durvalumab, but confirm eligibility and enroll only after first dose of durvalumab is received).
• Able to potentially receive further consolidation chemotherapy plus durvalumab and tremelimumab, but not be currently intended to receive additional systemic consolidation chemotherapy apart from this durvalumab.
• Pre-treatment tumor tissue or tumor DNA sample is believed to be available for analysis
• Aged 18 years or older
• Weight \> 30kg
• Life expectancy ≥ 12 weeks
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
⁃ Absolute neutrophil count \> 1.0 x 109/L (1000/mm3)
⁃ Platelets \> 75 x 109/L (100,000/mm3)
⁃ Hemoglobin ≥ 9.0 g/dL (5.59 mmol/L)
⁃ Measured creatinine clearance \> 40 mL/min, by either 24 hour urine collection or the Cockcroft Gault formula
⁃ Males:
⁃ Mass(kg) x (140-Age) / 72 x serum creatinine (mg/dL)
⁃ Females:
⁃ Mass(kg) x (140-Age) x 0.85 / 72 x serum creatinine (mg/dL)
⁃ Serum bilirubin ≤ 1.5 x upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology) who will be allowed in consultation with their physician.
⁃ aspartate aminotransferase (AST) (SGOT)/Alanine Aminotransferase (ALT) (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN) unless liver metastases are present, in which case it must be ≤ 5 x ULN
⁃ Ability to understand and the willingness to sign the written IRB approved informed consent document.