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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Medically Inoperable Stage I or IIA Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867 / KEYNOTE-867)

The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC). The primary study hypotheses are: 1. SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution), and 2. SBRT plus pembrolizumab prolongs Overall Survival (OS) compared to SBRT plus placebo.
Lung, Non Small Cell
Phase III
Adults
Mol. targeted/Immunotherapy/Biologics, Radiotherapy
Blinded Drug
Osmundson, Evan
International
Vanderbilt University
03-03-2020
Treatment
VICCTHO1940
NCT03924869

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Has previously untreated NSCLC diagnosed by histology or cytology and confirmed as Stage I or IIA NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan

Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board

Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Is able to receive SBRT and does not have an ultra-centrally located tumor

Has adequate organ function within 7 days prior to the start of study treatment

A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP who agrees to use study-acceptable contraception during treatment and for at least 120 days after last dose of study treatment



Exclusion Criteria:

Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], tumor necrosis factor receptor superfamily member 4 [OX-40], tumor necrosis factor receptor superfamily member 9 [CD137])

Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast

Has received a live vaccine within 30 days prior to the first dose of study treatment

Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment

Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.

Has a known hypersensitivity (?Grade 3) to pembrolizumab and/or any of its excipients

Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis

Has a known history of Hepatitis B or known active Hepatitis C virus infection

Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). However, replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency), while systemic, will be permitted for study eligibility.

Has an active infection requiring systemic therapy

Has a known history of human immunodeficiency virus (HIV) infection

Has a known history of active tuberculosis (TB; Bacillus tuberculosis)

Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment

Has had an allogenic tissue/solid organ transplant

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