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
Investigating the Effects of Immunotherapy in Unresectable Stage III Non-Small Cell Lung Cancer
Brief description of study.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: NSCLC,non-small cell lung cancer,non small cell lung cancer,non-small cell,non small cell,lung cancer,lung,lungs,cancer,oncology
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
Histological or cytological confirmation of NSCLC
Must have unresectable or inoperable stage IIIA or IIIB disease
Prior cancer treatment must be completed at least 28 days prior to registration
Demonstrate adequate organ function
Exclusion Criteria
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
Active central nervous system metastases
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
Presence of 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
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 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
History of human immunodeficiency virus (HIV) infection of chronic hepatitis B or C
Has a known history of active TB
Hypersensitivity to nivolumab, ipilimumab, or any of their excipients
This study investigates the effects of an investigational medication on patients with unresectable stage III non-small cell lung cancer (NSCLC). The purpose is to understand the benefits and side effects of using the investigational medication alone or in combination after patients have completed chemotherapy and radiation. NSCLC is a type of lung cancer that cannot be removed by surgery and has spread within the chest.
Participants will receive either the investigational medication alone or in combination. The study will monitor the effects of the treatment, which involves the body's immune system. This is called consolidation immunotherapy. Participants will be observed for any changes in their condition and any side effects they might experience.
- Who can participate: Adults with unresectable or inoperable stage IIIA or IIIB non-small cell lung cancer who have completed prior cancer treatment at least 28 days before joining the study and have adequate organ function are eligible. Participants must not have active infections, metastatic disease, autoimmune diseases requiring treatment, and must not be pregnant or breastfeeding.
- Study details: Participants will be randomly assigned to receive either the investigational medication alone or in combination with another. A placebo is not used in this study. Participants will be monitored for side effects and changes in their health.