NCT04485026

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Non Small Cell Lung Cancer
• Oligoprogressive

Interventions

Type	Name	Description
RADIATION	Local consolidative radiation therapy	All local consolidative radiation therapy should be delivered using hypofractionated local consolidative radiation therapy (\>2 Gy per fraction). Exceptions may be approved on a case by case basis by the trial principal investigator. Three-dimensional conformal radiotherapy (3D-CRT), intensity modulated radiation therapy (IMRT), volumetric modulated arc therapy (VMAT), stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS), and proton beam therapy (PBT) are all acceptable.
DRUG	Standard of care radiation therapy	Standard of care palliative radiotherapy to symptomatic lesions is permissible. The dose to symptomatic lesions should not exceed 30 Gy in 10 fractions. Brain metastases will be treated with standard of care CNS therapy throughout the study. This may include (but is not limited to) stereotactic radiosurgery, neurosurgical intervention, whole brain radiotherapy

Timeline

• Start date: 2020-11-04
• Primary completion: 2024-05-09
• Completion: 2024-05-09
• First posted: 2020-07-24
• Last updated: 2025-04-17

Regulatory

• FDA-regulated drug study