Induction Chemo-Nivo in Unresectable Stage III NSCLC

Ralph G Zinner

Status and phase: Terminated; Phase 2

Conditions: Lung Cancer, Nonsmall Cell; Lung Cancer Stage III

Treatments: Drug: Nivolumab; Procedure: Post Induction Surgery; Combination Product: Nivolumab and Chemotherapy; Radiation: Post Induction XRT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06003075

85869

Details and patient eligibility

About

The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Combination Chemotherapy and Nivolumab and Surgery

Experimental group

Description:

Patients with lung cancer receiving combination therapy with surgery

Treatment:

Radiation: Post Induction XRT

Combination Product: Nivolumab and Chemotherapy

Procedure: Post Induction Surgery

Drug: Nivolumab

Combination Chemotherapy and Nivolumab and Radiation

Experimental group

Description:

Patients with lung cancer receiving combination therapy with radiation

Treatment:

Radiation: Post Induction XRT

Combination Product: Nivolumab and Chemotherapy

Drug: Nivolumab