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The Selective Personalized Radio-Immunotherapy for Locally Advanced NSCLC Trial

NCT03523702 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-09

Study results available
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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.

Conditions

  • Non-small Cell Lung Cancer, NSCLC

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Nitin Ohri, MD · Albert Einstein College of Medicine

  • Nitin Ohri, MD · Montefiore Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2022-11-18
Completion
2022-11-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03523702 on ClinicalTrials.gov