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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT02221739
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
  • Radiotherapy (IMRT or 3-D CRT) — RADIATION

Study Details

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.

Key Dates

Start date
Jul 1, 2014
Status verified
Apr 2020
Primary completion
Apr 15, 2015
Completion
Oct 27, 2015

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ipilimumab + radiotherapy
    Patients receive ipilimumab (Ipi) 3mg/kg i.v. over 90 minutes, within 24 hours of starting radiotherapy (RT) to the biopsied lesion, 6 Gy x5, later changed to 9.5 Gy x3 (conformally or by intensity modulated RT (IMRT) with image guidance to maximally spare normal tissue). Ipilimumab is repeated on days 22, 43 (for patients who consent to the first biopsy), and 64. Repeat biopsy is performed between day 22-29, and patients are re-imaged between day 81-88 and evaluated for response (defined as an objective response by irRC of the measurable metastatic sites outside the radiation field).

Primary Outcome Measure

Therapeutic Efficacy of Anti-CTLA-4 mAb and Concurrent Local RT in NSCLC Patients With Metastatic Disease. [ Time Frame: 3 weeks - 6 months post treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
NYU Clinical Cancer CenterNew YorkNew York10016-
NYU Langone Medical Center, Tisch HospitalNew YorkNew York10016-

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By research site
NYU Clinical Cancer Center· New York, NYNYU Langone Medical Center, Tisch Hospital· New York, NY

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