A Trial Evaluating Stereotactic Radiotherapy Plus Durvalumab Continuation for Patients With NSCLC Metachronous Oligometastatic Disease Under Durvalumab Consolidation Following Chemoradiation

Sponsor
Institut Claudius Regaud
Study ID
NCT03955198
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a single-arm phase II, multicenter study designed to evaluate the activity of stereotactic radiotherapy plus the continuation of durvalumab for 12 more months for patients presenting with NSCLC metachronous oligometastatic disease during post-chemoradiotherapy durvalumab consolidation. Fifty patients will have to be enrolled in this phase II trial. Total duration of treatment will be 12 months. Patients will be followed for a maximum of 2 years following the date of inclusion.

Key Dates

Start date
May 27, 2021
Status verified
Sep 2024
Primary completion
Aug 26, 2024
Completion
Aug 26, 2024

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with NSCLC metachronous oligometastatic disease

Primary Outcome Measure

Progression-free survival defined as the time from inclusion to disease progression (per RECIST v1.1) or death from any cause, whichever occurs first. [ Time Frame: 24 months for each patient ]

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