Using Circulating Tumor DNA to Personalize Duration of Consolidation Durvalumab

Indiana University

Status and phase: Withdrawn; Phase 2

Conditions: NSCLC, Stage III

Treatments: Diagnostic Test: Signatera ctDNA test; Drug: Durvalumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05757843

CTO-IUSCCC-0749

Details and patient eligibility

About

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).

Full description

There is a critical need to identify MRD to determine which patients benefit from checkpoint inhibitor therapy and to optimize and personalize the duration of consolidation Durvalumab. The long-term goal is 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). This approach may spare a subset of patients from treatment with unnecessarily excessive cycles of consolidation immunotherapy if they are already cured with CRT alone and individualize the duration of consolidation immunotherapy in patients not cured with CRT. The study team also seek to identify early in the treatment course, patients who are destined not to be cured with consolidation immunotherapy so that alternative strategies can be tested when tumor burden is low.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Consolidation to Durvalumab

Experimental group

Description:

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.

Treatment:

Drug: Durvalumab

Diagnostic Test: Signatera ctDNA test