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Induction Chemo-Nivo in Unresectable Stage III NSCLC | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Induction Chemo-Nivo in Unresectable Stage III NSCLC

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)

NCT06003075•Ralph G Zinner

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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 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
+1 more criteria

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
+10 more criteria

Locations (1)

University of Kentucky

Lexington, Kentucky, United States

Key Dates

Start Date

December 13, 2023

Primary Completion Date

July 5, 2024

Completion Date

July 5, 2024

Last Updated

April 30, 2025

Enrollment

ACTUAL participants

Conditions

Lung Cancer, Nonsmall CellLung Cancer Stage III

Interventions

Nivolumab and Chemotherapy

COMBINATION_PRODUCT

Nivolumab

DRUG

Post Induction Surgery

PROCEDURE

Post Induction XRT

RADIATION

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

NCT05692635

Brain MetastasesNonsmall Cell Lung Cancer Stage III

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RECRUITINGPHASE2

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

NCT07250477

Non-small Cell Lung Cancer Stage IIICNon-small Cell Lung Cancer Stage IV+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Induction Chemo-Nivo in Unresectable Stage III NSCLC

Inclusion Criteria

Exclusion Criteria

Reducing the Incidence of Symptomatic Brain Metastases With MRI Surveillance

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

AK129 Combination Therapy for Advanced Solid Tumors

Alectinib Pharmacokinetic in Patients With NSCLC

Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Stage III NSCLC

Sequential Chemo-immunotherapy Plus Thoracic Radiotherapy for Elderly And/or Frail Stage III Non-small-cell Lung Cancer