Study on Adaptive Chemotherapy for Resectable Non-Small Cell Lung Cancer (NSCLC) with High PD-L1 Levels

Sponsor: University of Maryland, Baltimore

Sponsor score: 0

ClinicalTrials ID:NCT07746388

This clinical trial is exploring whether the drug cemiplimab can be safely used in adults with certain types of non-small cell lung cancer (NSCLC) that can be surgically removed. The study aims to see if some patients can skip chemotherapy before surgery and still achieve good results.

Patient Parameters

Parameter	Options

Program Overview

The purpose of this study is to determine if cemiplimab, an immune therapy drug, is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC) that can be surgically removed. Researchers want to find out if patients with high levels of a marker called PD-L1 can avoid chemotherapy before surgery and still have successful outcomes. All participants will receive cemiplimab, and no one will receive a placebo. The treatment involves two cycles of cemiplimab, followed by scans to check the tumor's response. Depending on the results, participants may receive an additional cycle of cemiplimab or a combination of chemotherapy and cemiplimab before surgery.

Description

The current standard treatment for patients with resectable non-small cell lung cancer (NSCLC) involves chemotherapy combined with an immune therapy drug before surgery. This approach has shown improved outcomes in previous studies. However, not all patients may need chemotherapy, especially those with high levels of a marker called PD-L1. This study aims to explore if using cemiplimab alone before surgery can be effective for these patients.

Researchers have reviewed data from previous studies and found that patients with high PD-L1 levels may respond well to cemiplimab alone, potentially avoiding the side effects of chemotherapy. This study will test this approach in 30 patients, using an adaptive treatment strategy. Participants will receive two cycles of cemiplimab, followed by scans to assess the tumor's response. Based on the results, they may receive an additional cycle of cemiplimab or a combination of chemotherapy and cemiplimab before surgery. This approach aims to tailor treatment to each patient's needs, improving outcomes while minimizing unnecessary side effects.

Eligibility Criteria

Inclusion Criteria

Be 18 years or older.
Have a good overall health status, with an ECOG performance score of 0 or 1.
Have a confirmed diagnosis of stage II-IIIB(N2) non-small cell lung cancer (NSCLC) that can be surgically removed.
Have their case reviewed by a multidisciplinary team to confirm suitability for surgery.
Provide a tumor sample for biomarker testing, including PD-L1 and EGFR/ALK status.
Have a PD-L1 Tumor Proportion Score (TPS) of 50% or higher.
Have no major health issues that increase surgery risk.
Have adequate lung function to tolerate surgery.
Have normal organ and blood function, including:
- Platelet count of at least 100,000/mm3
- Hemoglobin level of at least 8 g/dL
- Neutrophil count of at least 1000/mm3
- Creatinine level within normal limits or clearance of at least 40 mL/min
- Total bilirubin within normal limits, except for those with Gilbert Syndrome
Be capable of giving informed consent and have signed a consent form.
Women of childbearing potential must have a negative pregnancy test within 30 days of starting the study.

Exclusion Criteria

Have advanced or metastatic cancer that cannot be surgically removed.
Have a type of lung cancer called large-cell neuroendocrine carcinoma or small cell carcinoma.
Have known mutations in EGFR or ALK genes, or other specific genetic alterations.
Have brain metastases or other intracranial disease.
Have received prior therapy with certain immune therapy drugs.
Have had another active cancer within the past 3 years, except for certain skin or localized cancers.
Have a history of organ transplantation.
Have a condition that the study doctor believes would compromise safety or data quality.
Have significant heart disease or recent heart attack or stroke.
Require ongoing corticosteroid therapy above a certain dose.
Have an autoimmune disease requiring treatment in the past 5 years.
Have a recent or uncontrolled infection, including HIV, hepatitis B, or hepatitis C.
Have received a live vaccine within 4 weeks of starting the study.
Have received a COVID-19 vaccine within 1 week of starting the study.
Have an allergy to the study drug or its components.
Women and men who are unwilling to use effective contraception during the study and for 4 months after the last dose of cemiplimab.

Locations

FACILITY	ZIP	CITY	STATE
Indiana University	46202	Indianapolis	Indiana
University of Maryland Greenebaum Comprehensive Cancer Center	21201	Baltimore	Maryland
University Hospitals Seidman Cancer Center	44106	Cleveland	Ohio
Ohio State University Comprehensive Cancer Center	43210	Columbus	Ohio
University of Virginia Comprehensive Cancer Center	22903	Charlottesville	Virginia

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