Study on Nivolumab, Alone or with Ipilimumab, Before Surgery for Resectable Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60

ClinicalTrials ID:NCT02259621

This clinical trial is testing the safety and feasibility of using the immunotherapy drugs nivolumab, alone or combined with ipilimumab, before surgery in patients with high-risk resectable non-small cell lung cancer (NSCLC). The study aims to gather information that could help plan future treatments for NSCLC.

Patient Parameters

Parameter	Options

Program Overview

The study is exploring whether using the immunotherapy drugs nivolumab, alone or with ipilimumab, before surgery is safe and feasible for patients with high-risk resectable non-small cell lung cancer (NSCLC). Researchers will also study the immune environment of the tumors and the immune cells in the blood. This information will help in planning future clinical trials for NSCLC treatments, both before surgery and for advanced stages of the disease.

Description

This study is investigating the use of nivolumab, with or without ipilimumab, before surgery in patients with high-risk resectable non-small cell lung cancer (NSCLC). The goal is to determine if this approach is safe and feasible. Researchers will also examine the immune environment of the tumors and the immune cells in the blood to gather valuable information for future clinical trials. The study aims to identify potential biomarkers that could predict which patients are most likely to benefit from anti-PD-1 treatment and minimize the risk of side effects for those who may not benefit.

An amendment to the study allows for the evaluation of combining nivolumab with ipilimumab in the neoadjuvant setting for treating resectable NSCLC. In previous trials, the combination of ipilimumab and nivolumab showed a response rate of 39-47% in patients, with a lower incidence of severe side effects compared to traditional chemotherapy.

The study now includes a third treatment option (Arm C) that combines nivolumab with platinum-doublet chemotherapy before surgery.

Eligibility Criteria

Inclusion Criteria

Diagnosed with non-small cell lung cancer (NSCLC) confirmed by a biopsy.
Cancer type can be squamous or non-squamous.
Biopsy samples must be reviewed by a pathologist at specific medical centers.
Must provide a tumor sample for biomarker evaluation, either from archived tissues or a new biopsy.
Have high-risk NSCLC that can potentially be cured with surgery, as assessed by a surgeon.
Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
Adequate organ function, including:
- White blood cell count of at least 2,000/mm3.
- Neutrophil count of at least 1,000/mm3.
- Platelet count of at least 100,000/mm3.
- Hemoglobin level of at least 9 g/dL.
- Kidney function within specified limits.
- Liver function within specified limits.
Adequate lung function for surgery, determined by lung function tests.
Women of childbearing potential and men must agree to use effective contraception during the study and for a specified period after the last dose of nivolumab.
Must not be pregnant or breastfeeding.
Must understand the study and agree to sign an informed consent form.

Exclusion Criteria

Have an active or suspected autoimmune disease, except for certain stable conditions.
Require systemic treatment with corticosteroids or other immunosuppressive medications.
Have received chemotherapy or other cancer therapy before surgery.
Have active concurrent cancers other than NSCLC, except for certain non-threatening cancers.
Have brain metastasis or a history of symptomatic interstitial lung disease.
Have an active systemic infection or positive tests for Hepatitis B or C.
Have a positive history or test for HIV/AIDS.
Have a history of allergy to study drug components.
Are pregnant or nursing.
Men with female partners who are not willing to use contraception.
Have received prior therapy with certain immunotherapy drugs.
Have underlying medical conditions that could make the study drug hazardous or obscure the interpretation of side effects.
Are prisoners or involuntarily incarcerated.

Locations

FACILITY	ZIP	CITY	STATE
Johns Hopkins at Bayview Medical Center	21224	Baltimore	Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	21287	Baltimore	Maryland
Memorial Sloan Kettering	10065	New York	New York
Swedish Cancer Insitute	98026	Edmonds	Washington

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