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

NCT03141359 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-02-05

Study results available
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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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Atrium Health Levine Cancer Institute

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • John H Heinzerling · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-12
Primary Completion
2023-07-12
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT03141359 on ClinicalTrials.gov