Finding studies
Finding studies
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Lead
Catherine Shu
This is an open label, single arm, pilot study of adjuvant durvalumab+ tremelimumab (D+T) for patients with stage II-IIIB (excluding N3) NSCLC.The trial will evaluate the feasibility of adjuvant D+T in patients who have undergone surgical resection and standard of care (SOC) adjuvant treatment and subsequently develop detectable plasma ctDNA. 15 evaluable patients will be enrolled. Patients with resected stage II-IIIB (excluding N3) NSCLC who have completed adjuvant standard of care treatment will be pre-screened and consented for the trial. They will undergo ctDNA testing with the Signatera assay at the completion of adjuvant treatment and every 4 months thereafter with standard CT imaging assessment up to 1 year. Patients with detectable ctDNA at a mutant allele frequency of \>0.1% and no evidence of recurrence on CT imaging will be enrolled in the trial. They will receive durvalumab every 4 weeks for 4 cycles and tremelimuamb on cycles 1 and 3 with concomitant plasma ctDNA quantification. Patients will be followed with standard CT imaging of the chest as well as routine and exploratory blood tests every 4 months until 1 year after completion of D+T. They will also be followed for up to 3 years for determination of DFS and OS.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
