Induction Chemo-Nivo in Unresectable Stage III NSCLC
- Conditions
- Lung Cancer, Nonsmall CellLung Cancer Stage III
- Interventions
- Combination Product: Nivolumab and ChemotherapyDrug: NivolumabProcedure: Post Induction SurgeryRadiation: Post Induction XRT
- Registration Number
- NCT06003075
- Lead Sponsor
- Ralph G Zinner
- Brief Summary
The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 37
- Squamous and non-squamous non-small cell lung cancer that is at baseline, unresectable stage IIIA-IIIC (8th edition AJCC) and not previously treated
- PD-L1 level needs to be measured with values 0-100% eligible
- EGFR/ALK/ROS1 Wild Type or unknown genetic alterations in these genes
- ECOG Performance Status ≤ 1
- Adequate organ and marrow function
- Adequate pulmonary reserve (e.g., FVC, FEV1, TLC, FRC, and DLCO) capable of tolerating the proposed lung resection
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Clinical risk assessment of cardiac function using the New York Heart Association Functional Classification class 2B or better
- Ability to understand and the willingness to sign a written informed consent document
- Patients who have participated in a study with an investigational agent or device within 2 weeks of enrollment
- Any prior radiotherapy to the lung
- Any prior treatment for NSCLC
- Any prior therapy with anti-PD-1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Any history of a severe hypersensitivity reaction to any monoclonal antibody
- Any history of allergy to the study drug components
- primary tumors involving the esophagus
- pancoast tumors
- Patients cannot have primary tumors which would remain unresectable
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nivolumab or other agents used in study
- Any active or history of autoimmune disease (including any history of inflammatory bowel disease), or history of syndrome that required systemic steroids or immunosuppressive medications
- Ongoing requirement for systemic corticosteroids greater than the equivalent of prednisone 10mg
- previous malignancies
- history of interstitial lung disease
- Patients requiring continuous supplemental oxygen
- Use of any live vaccines against infectious diseases (e.g., influenza, varicella. etc.) within 4 weeks (28 days) of initiation of study therapy
- Active systemic infection requiring therapy
- Patients with uncontrolled intercurrent illness
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Combination Chemotherapy and Nivolumab and Surgery Nivolumab and Chemotherapy Patients with lung cancer receiving combination therapy with surgery Combination Chemotherapy and Nivolumab and Surgery Post Induction Surgery Patients with lung cancer receiving combination therapy with surgery Combination Chemotherapy and Nivolumab and Radiation Nivolumab and Chemotherapy Patients with lung cancer receiving combination therapy with radiation Combination Chemotherapy and Nivolumab and Surgery Post Induction XRT Patients with lung cancer receiving combination therapy with surgery Combination Chemotherapy and Nivolumab and Radiation Post Induction XRT Patients with lung cancer receiving combination therapy with radiation Combination Chemotherapy and Nivolumab and Surgery Nivolumab Patients with lung cancer receiving combination therapy with surgery Combination Chemotherapy and Nivolumab and Radiation Nivolumab Patients with lung cancer receiving combination therapy with radiation
- Primary Outcome Measures
Name Time Method Response rate after induction 9 weeks post induction radiographic response by cat scan
- Secondary Outcome Measures
Name Time Method overall survival (OS) 2 years defined as the duration of time from start of treatment to time of death
Change in Toxicity through study completion, up to 18 months To assess safety, investigators will evaluate the rate of toxicity as defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) scoring system.
Percent of participants receiving surgery date of surgery, approximately 10 weeks Rate of converting non-surgical stage III(A-C) to surgically resectable disease
Pathologic complete response (pCR) post surgery, approximately 10 weeks Number of participants with Pathologic Complete Response. Pathologic complete response (pCR) is defined by a surgical pathology specimen
Major pathological response (MPR) post surgery, approximately 10 weeks MPR rate, defined as number of participants with ≤ 10% residual tumor in lung and lymph nodes
Progression free survival (PFS) 2 years PFS is defined as the duration of time from start of treatment to time of disease progression or death, whichever occurs first.
Change in patient-reported Quality of Life as measured by FACT-TOI through study completion, up to 18 months patient-reported Quality of Life as measured by FACT-TOI (Functional Assessment of Cancer Therapy - Trial Outcome Index); defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS (lung cancer scale) scores obtained from 7-item questionnaires from the FACT-L (Version 4.0). Questions are on a 5-point scale from 0-4, where 0 = "not at all" and 4 = "very much." Scores range from 0 to 84; higher score indicates better physical aspects of quality of life (QoL).
Trial Locations
- Locations (1)
University of Kentucky
🇺🇸Lexington, Kentucky, United States