Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
In this study circulating tumor DNA (ctDNA) blood testing is used to detect the residual blood cancer. If residual cancer using this blood test is detected there may be at higher risk of having the cancer return. The study is going to test whether or not the number of circulating cancer cells detected in the blood can be reduced by administration durvalumab after the standard treatment if you are tested positive for the residual cancer.
• Pathologically (histologically or cytologically proven) NSCLC. Tumors with any component of small cell lung cancer are not allowed.
• Adenocarcinoma patients must NOT be positive for EGFR Exon 19 deletion or L858R mutation, or ALK or ROS1 rearrangement.
• AJCC 8th edition clinical or pathological stage IA2 to IIIC or locoregionally recurrent disease. Stage IA1 tumors are excluded unless recurrent with radiographic solid component -or- pathologic invasive component of \> 10 mm.
• Received curative intent therapy with surgery and/or radiation. Note: May have received chemotherapy.
• Completed all intended therapy (surgery, radiation, and/or chemotherapy) - AND- no more than 32 weeks has elapsed after the last day of this therapy.
• No known current radiographic or pathologic residual/recurrent disease (in the investigator's opinion) after completion of all intended therapy (for example, positive margins after surgery without adjuvant radiotherapy, or unequivocal radiographic evidence of residual or recurrent disease)
• Pre-treatment tumor tissue or tumor DNA sample is believed to be available for analysis
• Not received immunotherapy (PD-1, PD-L1, or CTLA-4 antibodies) or be intended to receive immunotherapy, apart from this study.
• Not received another systemic anti-cancer investigational product during the 4 weeks prior to enrollment.
• Aged 18 years or older
⁃ ECOG Performance Status of 0 or 1 (Appendix B)
⁃ Life expectancy ≥ 12 weeks
⁃ Acceptable laboratory parameters:
⁃ Absolute neutrophil count \> 1.0 x 109/L
⁃ Platelets \> 75 x 109/L
⁃ Hemoglobin ≥ 9.0 g/dL
⁃ Creatinine ≤ 1.5 x ULN; or Measured creatinine clearance (CL) \>40 mL/min; or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976)
⁃ 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.
⁃ AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN)
⁃ Ability to understand and the willingness to sign the written IRB approved informed consent document.
⁃ Women of childbearing potential or their male partner must agree to use a highly effective method of contraception from enrollment until 8 months after final study therapy. (see section 4.6.1)
⁃ Body weight \>30kg