RecruitingPhase 3NCT04585490

Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC

Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC


Sponsor

Maximilian Diehn

Enrollment

48 participants

Start Date

Aug 25, 2021

Study Type

INTERVENTIONAL

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a blood test for tumor DNA (ctDNA) to guide how much additional treatment people with stage III non-small cell lung cancer (NSCLC) should receive after standard chemoradiation and immunotherapy (durvalumab). If ctDNA is found in the blood, additional therapy may be added. **You may be eligible if...** - You are 18 years old or older - You have stage III NSCLC or locally recurring lung cancer that has been treated with chemotherapy and radiation - You are currently receiving consolidation durvalumab (immunotherapy) after completing chemoradiation - Less than 32 weeks have passed since your first durvalumab dose - You are in good general health (ECOG performance status 0 or 1) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your lung cancer has progressed during or after initial treatment - You have previously had immunotherapy other than as part of this study - You have serious autoimmune disease or other conditions that prevent participation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab

Cohort 1 (1500 mg IV every 21 days, for 1 year), •Cohort 2 (10mg/kg every 2 weeks for 1 year)

DRUGCarboplatin

Target area under the curve (AUC) not to exceed 750mg on Day 1 of every 21-day cycle

DRUGPemetrexed

500mg/m2 on Day 1 of every 21-day cycle

DRUGPaclitaxel

175mg/m2 on Day 1 of every 21-day cycle

DRUGCisplatin

Cisplatin (75mg/m2 per institution guidelines) may be substituted for Carboplatin

DEVICEAVENIO ctDNA Surveillance Kit

Roche Sequencing and Life Science kit to detect minimal residue disease (MRD)

DRUGTremelimumab

not to exceed 75mg IV on Day 1 of every 21-day cycle


Locations(1)

Stanford University

Stanford, California, United States

View Full Details on ClinicalTrials.gov

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NCT04585490