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Local Consolidative Radiotherapy for Oligoprogressive in Non-small Cell Lung Carcinoma

Non Small Cell Lung Cancer Clinical Trial

Official title:
A Randomized Phase II Study of Local Consolidative Radiotherapy Versus Standard of Care Second Line Systemic Therapy in Patients With Oligoprogressive NSCLC on Immune Checkpoint Inhibitors

Clinical Trial Summary

This is a randomized phase II study designed to evaluate the effect of local consolidative radiation therapy (LCT) to all sites of oligoprogressive disease in patients with metastatic non-small cell lung carcinoma who have progressed through first line systemic therapy containing an immune checkpoint inhibitor (ICI).

Clinical Trial Description

Primary Objective: To compare overall survival (OS) from the time of the time of randomization between the treatment and control groups. Secondary Objective(s) - To compare the extra-CNS PFS2 (EC-PFS2), defined as the time to extracranial disease progression on second line systemic therapy or death from the first day of local consolidative radiation therapy (treatment group) or from the start of second line therapy (control group). - To evaluate time to initiation of second line systemic therapy or palliative care after completion of local consolidative therapy in the treatment group - To compare the toxicities in the treatment and control groups; - To compare overall progression free survival from the time of the first day of local consolidative radiation therapy for the treatment group and from the start of second line therapy for the control group - To compare the pattern of next progression on second line therapy in the treatment group vs the control group. - To evaluate local progression in lesions treated with local consolidative radiation therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04485026
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Withdrawn
Phase Phase 2
Start date November 4, 2020
Completion date December 2025
View Details
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