Consolidation Pembrolizumab Following Chemoradiation in Patients With Inoperable/Unresectable Stage III NSCLC
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Pembrolizumab
Intervention description: Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pembrolizumab; MK-3475

Summary:

      This is an open label, multi-institutional, single arm phase II trial of consolidation
      therapy with pembrolizumab, following initial treatment with concurrent chemoradiation in
      patients with inoperable or unresectable stage IIIA or IIIB NSCLC. No randomization or
      blinding is involved.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological evidence of NSCLC

          -  Must have unresectable or inoperable stage IIIA or IIIB disease. Patients are
             considered unresectable or inoperable based on the judgment of the treating physician

          -  Must have completed concurrent chemoradiation with a standard chemotherapy regimen
             (either cisplatin/etoposide or carboplatin/paclitaxel) and a dose of radiation ranging
             from 59.4-66.6Gy

          -  Must have stable disease or disease response as evidenced on CT evaluation a minimum
             of 28 days and a maximum of 56 days following the completion of chemoradiation

          -  Women of childbearing potential must be willing to use two methods of contraception or
             abstain from heterosexual activity from the point of registration through 120 days
             after the last dose of study drug

          -  Male subjects of childbearing potential must agree to use an adequate method of
             contraception starting with the first dose of the study drug through 120 days after
             the last dose of the study drug

          -  Age ≥ 18 years at the time of consent

          -  Written informed consent and HIPAA authorization for release of personal health
             information

        Exclusion Criteria:

          -  Pregnant or breastfeeding, or expecting to conceive or father children within the
             projected duration of the trial, starting with the pre-screening or screening visit
             through 120 days after the last dose of trial treatment

          -  Active central nervous system (CNS) metastases. Subjects must undergo a head computed
             tomography (CT) scan or brain MRI within 28 days prior to registration for protocol
             therapy to exclude brain metastases if symptomatic or without prior brain imaging

          -  Treatment with any investigational agent within 28 days prior to registration for
             protocol therapy

          -  Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer, other than
             standard concurrent chemoradiation as described above

          -  Prior therapy with a PD-1, PD-L1, or CTLA-4 inhibitor or a lung cancer-specific
             vaccine therapy

          -  Presence of metastatic disease (stage IV NSCLC) is not allowed. Subjects must be
             evaluated with a PET scan within 28 days prior to registration for protocol therapy to
             exclude metastatic disease

          -  No active second cancers

          -  Evidence of active autoimmune disease requiring systemic treatment within the past 90
             days or a documented history of clinically severe autoimmune disease, or a syndrome
             that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or
             resolved childhood asthma/atopy would be an exception to this rule. Subjects that
             require intermittent use of bronchodilators or local steroid injections would not be
             excluded from the study. Subjects with hypothyroidism stable on hormone replacement or
             Sjogren's syndrome will not be excluded from the study

          -  Interstitial lung disease or history of pneumonitis requiring treatment with
             corticosteroids

          -  Diagnosis of immunodeficiency or is receiving chronic systemic corticosteroid therapy
             or other immunosuppressive therapy (excludes inhaled corticosteroids) within 7 days of
             first dose of study drug

          -  History of psychiatric illness or social situations that would limit compliance with
             study requirements

          -  Clinically active infection as judged by the treating investigator (≥ Grade 2 by CTCAE
             v4) including known human immunodeficiency virus (HIV) infection or chronic hepatitis
             B or C

          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality
             that might confound the results of the trial, interfere with the subject's
             participation for the full duration of the trial, or is not in the best interest of
             the subject to participate, in the opinion of the treating investigator