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Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT03285321
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : August 15, 2018
Sponsor:
Collaborators:
Bristol-Myers Squibb
Big Ten Cancer Research Consortium
Information provided by (Responsible Party):
Greg Durm, MD, Big Ten Cancer Research Consortium

Brief Summary:
This study is an open label, multicenter, randomized phase II trial of consolidation immunotherapy with either nivolumab alone or the combination of nivolumab and ipilimumab following concurrent chemoradiation in patients with unresectable stage III NSCLC.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Nivolumab Drug: Ipilimumab Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: Phase II Study of Consolidation Immunotherapy With Nivolumab and Ipilimumab or Nivolumab Alone Following Concurrent Chemoradiotherapy for Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC): BTCRC-LUN16-081
Actual Study Start Date : September 15, 2017
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm 1
Nivolumab 480mg IV every 4 weeks for up to 6 cycles
Drug: Nivolumab
480mg
Other Name: OPDIVO

Experimental: Arm 2
Nivolumab 3mg/kg IV every 2 weeks PLUS Ipilimumab 1mg/kg IV every 6 weeks for up to 4 cycles (12 doses Nivolumab and 4 doses of Ipilimumab)
Drug: Nivolumab
3mg/kg
Other Name: OPDIVO

Drug: Ipilimumab
1mg/kg
Other Name: Yervoy




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 18 months ]
    PFS is defined as the time from randomization until the criteria for disease progression is met as defined by RECIST 1.1 or death as a result of any cause.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 4 years ]
    The time from randomization until death from any cause. Will be assessed with RECIST 1.1

  2. Time to Metastatic Disease [ Time Frame: 4 years ]
    the time from randomization until evidence of disease outside of the radiated field. Will be assessed with RECIST 1.1

  3. Assess Adverse Events [ Time Frame: 4 years ]
    By the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.



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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:

Subject must meet all of the following applicable inclusion criteria to participate in this study:

  • Written informed consent and HIPAA authorization for release of personal health information.
  • Age ≥ 18 years at the time of consent.
  • ECOG Performance Status of 0 or 1 within 14 days prior to registration.
  • Histological or cytological confirmation of NSCLC. A pathology report confirming the diagnosis of NSCLC must be obtained and reviewed by the treating physician prior to registration to study.
  • Must have unresectable or inoperable stage IIIA or IIIB disease. Subjects must be considered unresectable or inoperable based on the judgment of the treating physician.
  • Subjects may have completed concurrent chemoradiation with a standard chemotherapy regimen (Cisplatin/Etoposide, Carboplatin/Paclitaxel or Cisplatin/Pemetrexed [non-squamous only]) and a dose of radiation ranging from 59.4-66.6 Gy. Subjects must have stable disease or disease response as evidenced on CT or PET scan evaluation. For those eligible, protocol therapy should begin a minimum of 28 days and a maximum 56 days following the completion of chemoradiation OR Subjects may have completed up to 2 cycles of consolidation therapy started within 4 weeks of completion of radiation. After completion of consolidation chemotherapy, subjects must have stable disease or disease response as evidenced by CT or PET scan evaluation. For those eligible, protocol therapy should begin 3-4 weeks after the last cycle of chemotherapy.
  • Prior cancer treatment must be completed at least 28 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤Grade 1 or baseline.
  • Demonstrate adequate organ function, all screening labs to be obtained within 14 days prior to registration:

Hematological:

  • Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm^3
  • Hemoglobin (Hgb) ≥ 9 g/dL
  • Platelets ≥100,000/mcl

Renal:

  • Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤ 1.5 x upper limit of normal (ULN) OR ≥ 60 mL/min for subjects with creatinine levels >1.5 x institutional ULN

Hepatic:

  • Bilirubin ≤ 1.5 × ULN OR Direct bilirubin of ≤ ULN for subjects with total bilirubin levels of >1.5x ULN
  • Aspartate aminotransferase (AST) ≤ 2.5 × ULN
  • Alanine aminotransferase (ALT) ≤ 2.5 × ULN

Coagulation:

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

    • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to registration. NOTE: Women are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are post-menopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 62 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.
    • Women of childbearing potential must be willing to abstain from heterosexual activity or use an effective method of contraception from the time of informed consent until 23 weeks after treatment discontinuation.
    • Men who are sexually active with women of childbearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year. Men receiving study drug and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product.
    • As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.

Exclusion Criteria:

Subjects meeting any of the criteria below may not participate in the study:

  • 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 23 weeks (female) or 31 weeks (male) 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 or up to 2 cycles of consolidation.
  • Prior therapy with a PD-1, PD-L1, PD-L2 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 CT or PET scan prior to registration for protocol therapy to exclude metastatic disease.
  • 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 site investigator (≥ Grade 2 by CTCAE v4).
  • History of 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 site investigator.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • Hypersensitivity to nivolumab, ipilimumab, or any of their excipients.
  • Has received a live vaccine within 30 days prior to planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

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): NCT03285321


Contacts
Contact: Michael Nunley 317.634.5842 ext 17 mnunley@bigtencrc.org
Contact: Chelsea Paton 317-278-0067 cmpaton@iu.edu

Locations
United States, Illinois
University of Illinois Cancer Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Erin Vidra    312-996-7902    evidra@uic.edu   
Principal Investigator: Lawrence Feldman, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Chelsea Paton    317-278-0067    cmpaton@iu.edu   
Contact: Greg Durm, MD       gdurm@iu.edu   
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Recruiting
Baltimore, Maryland, United States, 21287
Contact: Rachel Levy    410-502-8738    rlevy16@jhmi.edu   
Principal Investigator: Jarushka Naidoo, MB BCH         
United States, Michigan
Karmanos Cancer Center (Wayne State University) Recruiting
Detroit, Michigan, United States, 48201
Contact: Jay Rashid    313-576-9688    rashidj@karmanos.org   
Principal Investigator: Hirva Mamdani, MD         
Michigan State University Recruiting
Lansing, Michigan, United States, 48910
Contact: Karen Luellen    517-975-9534    karen.luellen@hc.msu.edu   
Principal Investigator: Borys Hrinczenko, MD         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Peggy Heires    402-559-4596    peggy.heires@unmc.edu   
Principal Investigator: Vinicius Ernani, MD         
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Karen Estok    732-235-4944    kestok@cinj.rutgers.edu   
Principal Investigator: Salma Jabbour, MD         
Sponsors and Collaborators
Greg Durm, MD
Bristol-Myers Squibb
Big Ten Cancer Research Consortium
Investigators
Study Chair: Greg Durm, M.D. Indiana University Health Simon Cancer Center

Additional Information:
Responsible Party: Greg Durm, MD, Sponsor-Investigator, Big Ten Cancer Research Consortium
ClinicalTrials.gov Identifier: NCT03285321     History of Changes
Other Study ID Numbers: BTCRC-LUN16-081
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Greg Durm, MD, Big Ten Cancer Research Consortium:
Nivolumab
Ipilimumab
immunotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs