Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC
NCT04585490 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-05-04
Summary
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
Conditions
- Non Small Cell Lung Cancer
- NSCLC, Stage III
- Nsclc
Interventions
- DRUG
-
Cohort 1 (1500 mg IV every 21 days, for 1 year), •Cohort 2 (10mg/kg every 2 weeks for 1 year)
- DRUG
-
Target area under the curve (AUC) not to exceed 750mg on Day 1 of every 21-day cycle
- DRUG
-
Pemetrexed
500mg/m2 on Day 1 of every 21-day cycle
- DRUG
-
175mg/m2 on Day 1 of every 21-day cycle
- DRUG
-
Cisplatin (75mg/m2 per institution guidelines) may be substituted for Carboplatin
- DEVICE
-
AVENIO ctDNA Surveillance Kit
Roche Sequencing and Life Science kit to detect minimal residue disease (MRD)
- DRUG
-
Tremelimumab
not to exceed 75mg IV on Day 1 of every 21-day cycle
Sponsors & Collaborators
- collaborator INDUSTRY
-
Maximilian Diehn
lead OTHER
Principal Investigators
-
Maximilian Diehn, MD · Stanford Universiy
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-25
- Primary Completion
- 2026-08-31
- Completion
- 2028-04-30
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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