Clinical trial NCT06003075: Induction Chemo-Nivo in Unresectable Stage III NSCLC
Official title: Phase II Study of Induction Platinum Doublet in Combination With Nivolumab Followed by Surgery or Concurrent Chemoradiation in Unresectable Stage IIIA-C Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lung Cancer, Nonsmall Cell
Lung Cancer Stage III
Keywords: Nivolumab
unresectable
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2023-08-21
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Chemo, biopsy, surgery with option for post op chemo or no surgery with concurrent chemo
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Response Rate After Induction
timeFrame: 9 weeks
Secondary outcomes:
measure: Change in Toxicity
timeFrame: through study completion, up to 18 months
measure: Percent of Participants Receiving Surgery
timeFrame: date of surgery, approximately 10 weeks
measure: Pathologic Complete Response (pCR)
timeFrame: post surgery, approximately 10 weeks
measure: Major Pathological Response (MPR)
timeFrame: post surgery, approximately 10 weeks
measure: Progression Free Survival (PFS)
timeFrame: 2 years
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Change in Patient-reported Quality of Life as Measured by FACT-TOI
timeFrame: through study completion, up to 18 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Ralph Zinner, MD
role: PRINCIPAL_INVESTIGATOR
References: