Study on Cemiplimab with Chemotherapy and Other Treatments for Adults with Operable Non-Small Cell Lung Cancer
Sponsor: Regeneron Pharmaceuticals
ClinicalTrials ID:NCT06465329
This clinical trial is testing whether adding an extra drug to the combination of cemiplimab and chemotherapy is more effective for treating early-stage non-small cell lung cancer (NSCLC) in adults who are planning to have surgery.
Patient Parameters
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Program Overview
The study involves adults with early-stage non-small cell lung cancer (NSCLC) who are scheduled for surgery. It aims to determine if a new treatment, which includes the immunotherapy drug cemiplimab, chemotherapy, and an additional drug, is more effective than just cemiplimab and chemotherapy. Researchers are also examining the side effects of these treatments, their impact on the type of surgery performed, how much of the drugs are present in the blood, and whether the body produces antibodies against the drugs, which could affect their effectiveness or cause side effects.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage II to IIIB non-small cell lung cancer that can be surgically removed with the goal of curing the disease.
- Have a tumor that can be measured using standard criteria.
- Able to provide a sample of the tumor for research purposes.
- In good general health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate organ and bone marrow function as determined by specific medical tests.
Exclusion Criteria
- Have received any previous cancer treatment or radiation for the current tumor.
- Have specific genetic changes in the tumor that are known to affect treatment response.
- Have moderate to severe nerve damage.
- Have another active cancer that is progressing or requires treatment.
For Arm 1 of the study:
- Have high levels of calcium in the blood.
- Have any brain conditions that could increase the risk of certain side effects.
- Have heart rhythm issues that could be worsened by the treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Orchard Healthcare Research Inc. | 60077 | Skokie | Illinois |
| Detroit Clinical Research Center | 48334 | Farmington Hills | Michigan |
| Morristown Medical Center | 07960 | Morristown | New Jersey |
| Providence Portland Medical Center | 97213 | Portland | Oregon |
| Lifespan Cancer Institute | 02903 | Providence | Rhode Island |
| University of Tennessee Medical Center | 37920 | Knoxville | Tennessee |
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