CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Immuno-Therapeutic Agent +1 moredrug
Likely dose
Hypofractionated radiation therapy: 24-45 Gy in 3 fractions (8-15 Gy/fraction) or 30-50 Gy in 5 fractions (6-10 Gy/fraction). Checkpoint inhibitors: nivolumab 240 mg or 3 mg/kg every 2 weeks; pembrolizumab 200 mg every 3 weeks; atezolizumab 1200 mg every 3 weeks; durvalumab 10 mg/kg every 2 weeks (per FDA-approved regimens).AI-extracted
Key inclusion· 5
  • Stage IV metastatic non-small cell lung cancer
  • Measurable disease of at least 1.5 cm at ≥2 non-irradiated sites (≥1.5 cm short-axis for lymph nodes) with ≥1 visceral organ metastasis outside the brain
  • Prior cytotoxic chemotherapy with subsequent distant metastatic disease relapse or progression while on chemotherapy
  • Planned to receive or actively receiving checkpoint inhibitor immune therapy (≤4 months duration if already on therapy)
Key exclusion· 4
  • Active autoimmune disease, primary immunodeficiency, HIV/AIDS, or hepatitis B or C
  • Oral corticosteroid dependency
  • Uncontrolled or untreated brain metastases or CNS disease
  • Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, or cardiac arrhythmia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03035890
NCT03035890N/ACompleted

Use of Response-Adapted Hypofractionated Radiation Therapy to Potentiate the Systemic Immune Response to Checkpoint Inhibitors in Non-Small Cell Lung Cancer

West Virginia University·interventional·Posted Jan 30, 2017·Updated Apr 1, 2025

In Brief

A clinical study evaluating Radiation and Immuno-Therapeutic Agent for Non Small Cell Lung Cancer Metastatic. Completed, enrolled 35 participants across 1 site.

Detailed Summary

This study includes the additional use of radiation therapy in combination immunotherapy in order to determine whether the radiation may improve the response of non-small cell lung cancer to immunotherapy and to monitor any side effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 30, 2017
Enrollment StartJan 23, 2017
Primary CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 9.4 years ago

Interventions

Radiationradiation

Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy)

Immuno-Therapeutic Agentdrug

Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include: * Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle) * Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle) * Atezolizumab 1200 mg once every 3 weeks (21 day cycle) These agents should be continued per standard of care until either disease progression or unacceptable toxicity.