NCT03523702

The Selective Personalized Radio-Immunotherapy for Locally Advanced NSCLC Trial

The Selective Personalized Radio-Immunotherapy for Locally Advanced NSCLC Trial (SPRINT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to explore if, for locally advanced non-small cell lung cancer patients whose tumors have high levels of PD-L1 (a marker associated with benefits from immunotherapy), a combination of immunotherapy and a personalized 4-week radiotherapy course could be more effective than standard treatment, which is a combination of chemotherapy and radiotherapy.

Detailed description

This is a Phase II trial evaluating the efficacy and safety of sequential pembrolizumab (200 mg every three weeks) and accelerated, dose-painted radiotherapy for patients with locally advanced NSCLC with PD-L1 expression ≥ 50%. Patients with PD-L1 expression \< 50% will be treated with concurrent chemoradiotherapy as part of standard of care.

Conditions

• Non-small Cell Lung Cancer, NSCLC

Interventions

Type	Name	Description
DRUG	PembroRT	Patients whose tumors are found to have high (≥ 50%) PD-L1 expression will automatically be placed in the PembroRT group. These patients will receive three intravenous treatments with pembrolizumab, followed by four weeks of daily radiotherapy, followed by up to 12 more treatments with pembrolizumab. Pembrolizumab is given as an intravenous infusion once every three weeks. This treatment course will last, in total, up to one year. Patients whose tumors are found to have low (\< 50%) PD-L1 will be treated with a standard-o-care regimen and not be a part of this clinical trial.

Timeline

• Start date: 2018-08-30
• Primary completion: 2022-11-18
• Completion: 2022-11-18
• First posted: 2018-05-14
• Last updated: 2026-04-09
• Results posted: 2024-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study