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Consolidation Pembrolizumab Following Chemoradiation in Patients With Inoperable/Unresectable Stage III NSCLC

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ClinicalTrials.gov Identifier: NCT02343952
Recruitment Status : Active, not recruiting
First Posted : January 22, 2015
Last Update Posted : January 6, 2021
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Hoosier Cancer Research Network
Information provided by (Responsible Party):
Nasser Hanna, M.D., Hoosier Cancer Research Network

Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Pembrolizumab Phase 2

Detailed Description:

OUTLINE: This is a multi-center study.

Eligible patients 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, with restaging completed 28 days to 56 days post-chemoradiation. Patients with progressive disease will not be eligible for investigational treatment. Patients with stable disease/response will be eligible to register for investigational treatment of consolidation therapy to begin a minimum of 28 days and a maximum of 56 days from completion of chemoradiotherapy.

INVESTIGATIONAL TREATMENT:

Pembrolizumab, 200 mg IV every 3 weeks (until progressive disease (PD), unacceptable toxicity, or after 12 months (52 weeks) of therapy with pembrolizumab.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Hematopoietic:

  • Absolute neutrophil count (ANC) ≥1,500/mcL
  • Platelets ≥100,000/mcL
  • Hemoglobin ≥9 g/dL or ≥5.6 mmol/L

Renal:

  • Serum creatinine OR measured or calculated creatinine clearance ≤1.5 X institutional upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl)

Hepatic:

  • Serum total bilirubin ≤ 1.5 X institutional ULN OR direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 institutional ULN
  • Aspartate transaminase (AST), serum glutamic oxaloacetic transaminase (SGOT), alanine transaminase (ALT), serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 X institutional ULN

Coagulation:

  • International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X institutional ULN unless subject is receiving anticoagulant therapy as long as PT/INR/PTT is within therapeutic range of intended use of anticoagulants.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Concurrent Chemoradiation With Consolidation Pembrolizumab for the Treatment of Inoperable or Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): HCRN LUN14-179
Study Start Date : March 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Arm
Pembrolizumab
Drug: Pembrolizumab
Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
Other Name: MK-3475




Primary Outcome Measures :
  1. Time to Death or Distant Metastasis [ Time Frame: From completion of treatment until death or distant metastasis (estimate 18 months) ]
    To determine if consolidation therapy with pembrolizumab, following concurrent chemoradiation improves time to death or distant metastatic disease, depending on which occurs first, in patients with inoperable or unresectable stage IIIA or IIIB NSCLC. Distant metastasis is defined as anything that is outside of the radiation field.


Secondary Outcome Measures :
  1. Disease Assessment for Progression Free Survival [ Time Frame: Every 9 weeks for up to 12 months ]
    To determine if consolidation therapy with pembrolizumab, following concurrent chemoradiation improves progression free survival (PFS) and overall survival (OS) in patients with inoperable or unresectable stage IIIA or IIIB NSCLC.

  2. Overall Survival [ Time Frame: From completion of treatment until death or distant metastasis (estimate 18 months) ]
    To determine if consolidation therapy with pembrolizumab, following concurrent chemoradiation improves progression free survival (PFS) and overall survival (OS) in patients with inoperable or unresectable stage IIIA or IIIB NSCLC.

  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Every 3 weeks (Day 1) for up to 12 months ]
    To assess safety and tolerability of consolidation therapy with pembrolizumab, following concurrent chemoradiation in patients with inoperable or unresectable stage IIIA or IIIB NSCLC.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343952


Locations
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United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
United States, Indiana
Fort Wayne Oncology & Hematology, Inc.
Fort Wayne, Indiana, United States, 46845
IU Health Goshen Hospital
Goshen, Indiana, United States, 46527
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
IU Health Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
Community Regional Cancer Care
Indianapolis, Indiana, United States, 49256
IU Health Arnett Cancer Center
Lafayette, Indiana, United States, 47904
Horizon Oncology Research, Inc.
Lafayette, Indiana, United States, 47905
IU Health at Ball Memorial Hospital
Muncie, Indiana, United States, 47303
Oncology Hematology Associates of SW Indiana
Newburgh, Indiana, United States, 47630
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
United States, Kentucky
University of Louisville, James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Nebraska
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68114
United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Nasser Hanna, M.D.
Merck Sharp & Dohme Corp.
Hoosier Cancer Research Network
Investigators
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Study Chair: Nasser Hanna, M.D. Hoosier Cancer Research Network
Additional Information:
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Responsible Party: Nasser Hanna, M.D., Sponsor-Investigator, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT02343952    
Other Study ID Numbers: HCRN LUN14-179
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Nasser Hanna, M.D., Hoosier Cancer Research Network:
Pembrolizumab
MK-3475
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents