Using Circulating Tumor DNA to Personalize Duration of Consolidation Durvalumab

NCT05757843 | Withdrawn Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: CTO-IUSCCC-0749
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research aims to incorporate ctDNA analysis into clinical practice to individualize therapy in patients with stage III NSCLC by moving to a treatment-by-marker based approach (as opposed to treatment based on clinical or radiographic evidence of disease).

Conditions

NSCLC, Stage III

Outcome Measures

Primary Outcomes (1)

• Determine if de-escalating number of Durvalumab cycles based on personalized ctDNA clearance has non-inferior 2-year PFS rate

  Determine if de-escalating the number of Durvalumab cycles based on personalized ctDNA clearance guidance to at least 6 cycles after CRT in stage III non-resectable NSCLC has non-inferior 2-year PFS rate compared with historical control of empirically treating stage III non-resectable NSCLC for 1 year of Durvalumab after CRT.

  Baseline to 24 months

Secondary Outcomes (2)

• Estimate the 24-month overall survival (OS) of patient treated with consolidation Durvalumab based on personalized ctDNA clearance

  Baseline to 24 months

• Estimate the 24-month PFS in patients with persistently detectable ctDNA without radiographic progression

  Baseline to 24 months

Study Arms (1)

Consolidation to Durvalumab

EXPERIMENTAL

All subjects will receive consolidation Durvalumab approximately every 4 weeks. The first mandatory ctDNA test will be done at screening for the bespoke ctDNA profiling. The next mandatory ctDNA test will be completed prior to the 5th cycle of consolidation Durvalumab. If it's negative and the subsequent test 4 weeks later prior to cycle 6 is negative, then Durvalumab will be stopped otherwise subject will continue consolidation durvalumab until 2 negative ctDNA analyses performed approximately 4 weeks apart or up to 1 year of consolidation per standard medical practice is complete.

Diagnostic Test: Signatera ctDNA test; Drug: Durvalumab

Interventions

Signatera ctDNA test DIAGNOSTIC_TEST

The first mandatory ctDNA test will be done at screening for the bespoke ctDNA profiling. The next mandatory ctDNA test will be completed prior to the 5th cycle of consolidation Durvalumab. ctDNA testing will be repeated approximately every 4 weeks until two consecutive negative analyses occur. ctDNA testing will be otherwise discontinued after progressive disease or after up to 1 year of consolidation treatment per standard medical practice is considered complete, whichever occurs first.

Consolidation to Durvalumab

Durvalumab DRUG

All subjects will receive consolidation Durvalumab approximately every 4 weeks. Durvalumab will be stopped after two consecutive negative ctDNA analyses occur.

Consolidation to Durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Ability to provide written informed consent and HIPAA authorization
• Patients with inoperable or unresectable stage III NSCLC who are planning to receive concurrent CRT followed by consolidation Durvalumab OR Patients with inoperable or unresectable stage III NSCLC who have previously received concurrent CRT and are planning or currently receiving C1-4 consolidation durvalumab
• Must have viable tissue for ctDNA profiling, (fresh or archived tissue)

You may not qualify if:

• Patient unwilling to provide tissue and blood samples for ctDNA testing.
• Patient has contraindications to treatment with concurrent CRT and/or consolidation Durvalumab.
• Patients with any other active cancer; excluding squamous cell or basal cell cancer.

Sponsors & Collaborators

• Indiana University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nasser Hanna, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tom and Julie Wood Family Foundation Professor of Lung Cancer Clinical Research

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: September 13, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09