NCT04585490

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Maximilian Diehn · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 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 baseline undetectable ctDNA (Cohort 2 MRD ) ·To compare progression free survival (PFS) between subjects with baseline detectable (Cohort 1 MRD+) vs baseline undetectable ctDNA (Cohort 2 MRD )

Conditions

• Non Small Cell Lung Cancer
• NSCLC, Stage III
• Nsclc

Interventions

Type	Name	Description
DRUG	Durvalumab	Cohort 1 (1500 mg IV every 21 days, for 1 year), •Cohort 2 (10mg/kg every 2 weeks for 1 year)
DRUG	Carboplatin	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	Paclitaxel	175mg/m2 on Day 1 of every 21-day cycle
DRUG	Cisplatin	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

Timeline

• Start date: 2021-08-25
• Primary completion: 2026-04-01
• Completion: 2028-04-01
• First posted: 2020-10-14
• Last updated: 2025-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study