Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Non -Small Cell Lung Cancer
- NSCLC
- NSCLC, Stage III
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary objective is to measure the change in the levels of circulating tumor DNA (ctDNA) in Cohort 1 (MRD+) due to the addition of platinum doublet chemotherapy in subjects with stage III unresectable disease with positive DNA treated with consolidation chemotherapy and immunotherapy. Secondary Obj...
Primary objective is to measure the change in the levels of circulating tumor DNA (ctDNA) in Cohort 1 (MRD+) due to the addition of 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 chemotherapy To describe overall survival (OS) of subjects with baseline detectable ctDNA (Cohort 1 MRD+) vs baseline undetectable ctDNA (Cohort 2 MRD ) ·To describe progression free survival (PFS) between subjects with baseline detectable (Cohort 1 MRD+) vs baseline undetectable ctDNA (Cohort 2 MRD ) ·To describe the frequency and severity of toxicity of consolidation durvalumab plus chemotherapy
Tracking Information
- NCT #
- NCT04585490
- Collaborators
- AstraZeneca
- Investigators
- Principal Investigator: Maximilian Diehn, MD Stanford Universiy
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