Stanford University
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
Primary objective is to measure the change in the levels of circulating tumor DNA (ctDNA) in Cohort 1 (MRD+) due to the addition of Tremelimumab and platinum doublet chemotherapy in subjects with stage III unresectable disease with positive DNA treated with consolidation chemotherapy and immunotherapy. Secondary Objectives: To determine the proportion of subjects in Cohort 1 MRD+ for whom ctDNA becomes undetectable after adding chemotherapy and tremelimumab to consolidation durvalumab To describe compare overall survival (OS) of subjects with baseline detectable ctDNA (Cohort 1 MRD+) vs bas…
Inclusion Criteria: 1. 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. 2. 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. 3. Must be receiving consolidation durvalumab following completion of radiation and chemotherapy, and less than 32 weeks has elapsed from their first dose o…
Cohort 1 (1500 mg IV every 21 days, for 1 year), •Cohort 2 (10mg/kg every 2 weeks for 1 year)
Target area under the curve (AUC) not to exceed 750mg on Day 1 of every 21-day cycle
500mg/m2 on Day 1 of every 21-day cycle
175mg/m2 on Day 1 of every 21-day cycle
Cisplatin (75mg/m2 per institution guidelines) may be substituted for Carboplatin
Roche Sequencing and Life Science kit to detect minimal residue disease (MRD)
not to exceed 75mg IV on Day 1 of every 21-day cycle
Arctuva estimate
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