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

NCT03285321 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BTCRC-LUN16-081
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 12

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Nivolumab; Ipilimumab; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) at 18-month

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. 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.

  18 months

Secondary Outcomes (3)

• Overall Survival (OS)

  4 years

• Time to Metastatic Disease (TTMD) at 36 Month

  36 Months

• Number of Participants With Adverse Events

  Up to 12 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Nivolumab 480mg IV every 4 weeks for up to 6 cycles

Drug: Nivolumab

Arm 2

EXPERIMENTAL

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)

Drug: Nivolumab; Drug: Ipilimumab

Interventions

Nivolumab DRUG

480mg

Also known as: OPDIVO

Arm 1

Ipilimumab DRUG

1mg/kg

Also known as: Yervoy

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Greg Durm, MD: lead
• Big Ten Cancer Research Consortium: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (12)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Louisville James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive

Baltimore, Maryland, 21287, United States

Location

Karmanos Cancer Center (Wayne State University)

Detroit, Michigan, 48201, United States

Location

Michigan State University

Lansing, Michigan, 48910, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Links

• Big Ten Cancer Research Consortium Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Fauzia Sharmin
• Organization: Hoosier Cancer Research Network

fsharmin@hoosiercancer.org

317-921-2050

Study Officials

• Greg Durm, M.D.

  Indiana University Health Simon Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: September 15, 2017
• Primary Completion: October 13, 2023
• Study Completion: February 6, 2024
• Last Updated: January 20, 2026
• Results First Posted: March 11, 2025

Record last verified: 2025-12

Locations

US (12)