NCT03141359

Use of High Dose Radiation Followed by Chemotherapy and Radiation to Treat Locally Advanced NSCLC

LCI-LUN-NSC-SBRT-001: Phase II Prospective Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation and Adjuvant Immunotherapy for Locally-Advanced Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, single-stage Phase II study designed to evaluate the 1-year PFS rate in subjects with locally-advanced NSCLC (stage II/III) and treated with Stereotactic Body Radiation Therapy (SBRT) followed by concurrent mediastinal chemoradiation with or without consolidation chemotherapy. A total of 60 subjects will be enrolled to this study over a 4 year accrual period.

Detailed description

This study's primary objective is to assess the efficacy of a treatment regimen involving Stereotactic Body Radiation Therapy (SBRT) delivered to the primary tumor followed by concurrent mediastinal chemoradiation by evaluating the proportion of subjects with locally-advanced non-small cell lung cancer (NSCLC) stage II/III who are alive and progression free at 12 months, and to compare to relevant historical controls. Additionally, the treatment regimen will be evaluated based on progression free survival, overall survival, radiologic clinical complete response rate following completion of therapy, objective response rate as defined by RECIST v 1.1, local and locoregional control, patterns of failure, and quality of life. Safety objectives include the rate of grade 2+ radiation pneumonitis and grade 3+ pulmonary events. Exploratory objectives include differential expression of cytokines and chemokines associated with radiation therapy will be determined.

Conditions

• Lung Cancer Stage II
• Lung Cancer Stage III
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	SBRT	Primary tumor SBRT
DRUG	Carboplatin	concurrent chemotherapy
DRUG	Paclitaxel	concurrent chemotherapy
DRUG	cis Platinum	concurrent chemotherapy
DRUG	Etoposide	concurrent chemotherapy
RADIATION	IMRT	mediastinal radiation
DRUG	Durvalumab	adjuvant immunotherapy

Timeline

• Start date: 2017-05-12
• Primary completion: 2023-07-12
• Completion: 2027-07-01
• First posted: 2017-05-05
• Last updated: 2026-02-05
• Results posted: 2024-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study