Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03285321|
Recruitment Status : Active, not recruiting
First Posted : September 18, 2017
Last Update Posted : September 2, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Nivolumab Drug: Ipilimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|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 :||August 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: Arm 1
Nivolumab 480mg IV every 4 weeks for up to 6 cycles
Other Name: OPDIVO
Experimental: Arm 2
Nivolumab 240mg 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)
Other Name: OPDIVO
Other Name: Yervoy
- 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.
- Overall Survival (OS) [ Time Frame: 4 years ]The time from randomization until death from any cause. Will be assessed with RECIST 1.1
- 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
- Assess Adverse Events [ Time Frame: 4 years ]By the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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 according to the 7th edition IASLC stage classification for lung cancer. Subjects must be considered unresectable or inoperable based on the judgment of the treating physician.
- Subjects must have completed concurrent chemoradiation with a platinum doublet 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 within 56 days of completing chemoradiation OR Subjects must have completed up to 2 cycles of consolidation therapy started within 56 days 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 within 56 days after the last cycle of chemotherapy.
- Prior cancer treatment must be completed between 1-56 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:
- Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm^3
- Hemoglobin (Hgb) ≥ 9 g/dL
- Platelets ≥100,000/mcl
- 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
- 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
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 to be considered post-menopausal.
- 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.
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.
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
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|University of Illinois Cancer Center|
|Chicago, Illinois, United States, 60612|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Kentucky|
|University of Louisville James Graham Brown Cancer Center|
|Louisville, Kentucky, United States, 40202|
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive|
|Baltimore, Maryland, United States, 21287|
|United States, Michigan|
|Karmanos Cancer Center (Wayne State University)|
|Detroit, Michigan, United States, 48201|
|Michigan State University|
|Lansing, Michigan, United States, 48910|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|United States, Pennsylvania|
|Penn State Cancer Institute|
|Hershey, Pennsylvania, United States, 17033|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53705|
|Study Chair:||Greg Durm, M.D.||Indiana University Health Simon Cancer Center|
|Responsible Party:||Greg Durm, MD, Sponsor-Investigator, Big Ten Cancer Research Consortium|
|Other Study ID Numbers:||
|First Posted:||September 18, 2017 Key Record Dates|
|Last Update Posted:||September 2, 2022|
|Last Verified:||August 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action