CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Ipilimumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02221739
NCT02221739Phase 2Completed

Phase II Study of Combined Ionizing Radiation and Ipilimumab in Metastatic Non-small Cell Lung Cancer (NSCLC)

NYU Langone Health·interventional·Posted Aug 20, 2014·Updated May 11, 2020

In Brief

A Phase 2 clinical trial evaluating Ipilimumab and Radiotherapy (IMRT or 3-D CRT) for Non-small Cell Lung Cancer (NSCLC). Completed, enrolled 39 participants across 2 sites.

Detailed Summary

The purpose of this study is to investigate how effective and how safe the combination of radiation therapy and an investigational medication targeting the immune system known as Ipilimumab in the treatment of metastatic non-small cell lung cancer (NSCLC). The investigators would like to see if this combination of radiation and Ipilimumab can stimulate the body's immune system to stop the growth of tumors that are outside the field of radiation. The investigators would like see if using this combination of radiation therapy with Ipilimumab could help the body reject the patient's own tumor or at least help their immune system to maintain the disease stable and/or slow its growth. Radiation therapy (RT) is currently a standard procedure for treatment of NSCLC. Ipilimumab is considered an investigational medication because it is not approved by the Food and Drug Administration (FDA) for the treatment of NSCLC. Ipilimumab has been approved by the FDA for the treatment of metastatic melanoma.

Study Details

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

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 20, 2014
Enrollment StartJul 1, 2014
Primary CompletionApr 15, 2015
Study CompletionOct 27, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.9 years ago

Interventions

Ipilimumabdrug

Radiotherapy (IMRT or 3-D CRT)radiation