Non-small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
Phase II Study of Combined Ionizing Radiation and Ipilimumab in Metastatic Non-small Cell Lung Cancer (NSCLC)
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.
Research Hypothesis:
1. Through a combination of local RT and ipilimumab an anti-tumor immune response is
elicited at the irradiated site, as an in vivo, individualized immunization that is
systemically effective, as reflected by objective responses outside the RT field
(abscopal effect).
2. The immune response can be prospectively monitored among the treated patients.
Objective 1: Evaluate the safety and therapeutic efficacy of anti-cytotoxic
T-lymphocyte-associated protein -4 mono clonal Antibody (anti-CTLA-4 mAb) and concurrent
local RT in NSCLC patients with metastatic disease.
An open label phase II trial will evaluate the preliminary efficacy of the combination of Ipi
and RT, applied to a single metastatic site. Efficacy is measured with respect to systemic
tumor responses (abscopal response, outside the field of therapy) defined by immune-related
Response Criteria (irRC) in all non-irradiated measurable lesions, as a demonstration of an
effective anti-tumor immune response. Secondary endpoints include local response in the RT
treated tumor, progression free survival, and overall survival.
Objective 2: Determine the effects of RT and anti-CTLA-4 mAb on development of anti-tumor
immunity.
The investigators hypothesize that RT will convert the irradiated tumor into an in situ
vaccine and elicit an endogenous tumor-specific cellular and humoral immune response, which
in the presence of cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blockade will promote
immune-mediated destruction of the irradiated and abscopal metastases. Pre- and
post-treatment tumor biopsies will be examined for changes in immune contexture, and blood
for evidence of emerging anti-tumor immune responses. Associations with clinical response
will be explored.
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