Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Eva Pereira
CONTACT
Lead
Fundación GECP
This is an open-label, phase III, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial. Patients stage IB to IIIA-IIIB (T3N2) after surgical resection if they did not achieve a pathological com-plete response (pCR) will be randomized 1:1:1 to: * ARM 1: Observational Arm for 10 months * ARM 2: Immunotherapy (Zimberelimab) treatment for 13 cycles, Q3W * ARM 3: Sacituzumab Govitecan + Zimberelimab Q3W for 8 cycles + Zimberelimab Q3W for 5 cycles. Patients will receive 8 cycles of the combination and 5 cycles of Zimberelimab monotherapy. The primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time. Disease Free survival (DFS): The time from random assignment to cancer recurrence or death from any cause. Secondary objectives: * Overall survival (OS): at 12, 24 and 36 months after the start of adjuvant treatment * Safety and tolerability of the combination of Sacituzumab Govitecan + Zimberelimab according to CTCAE v5.0. Exploratory objectives \- To evaluate whether there is a significant association between change in levels of ctDNA between baseline and after adjuvant treatment and OS and DFS. The total trial duration will be 7 years approximately. Approval-start up: 4-6 months. Patient accrual is expected to be completed within 2 years. One year of treatment and 3 years of follow up, and close-out: 4-6 months. The study will end once survival follow-up has concluded
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
