Study on Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40

ClinicalTrials ID:NCT06623656

This clinical trial is exploring whether combining the drug Cemiplimab with either chemotherapy or targeted radiation therapy before surgery can effectively treat stages IB, II, and III (N2) Non-Small Cell Lung Cancer (NSCLC).

Patient Parameters

Program Overview

The aim of this study is to determine if using Cemiplimab with chemotherapy or Cemiplimab with a type of targeted radiation therapy called stereotactic body radiation therapy (SBRT) before surgery can help treat stages IB, II, and III (N2) Non-Small Cell Lung Cancer (NSCLC). Participants will receive either Cemiplimab with chemotherapy or Cemiplimab with SBRT before their surgery. After surgery, all participants will continue to receive Cemiplimab for one year.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of stages IB, II, or III (N2) Non-Small Cell Lung Cancer (NSCLC) that can be surgically removed.
  • Have measurable cancer as defined by specific medical criteria.
  • Have known PD-L1 expression.
  • Do not have known EGFR mutations or ALK fusions.
  • Be 18 years or older.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have not received any prior therapy for lung cancer.
  • Have adequate organ and bone marrow function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Agree to use effective contraception during the study and for six months after the last treatment.
  • Men must agree not to donate sperm during the study and for six months after the last treatment.

Exclusion Criteria

  • Have a history of another primary cancer, except for certain treated cancers with no active disease for at least two years.
  • Have used immunosuppressive medication within 14 days before starting Cemiplimab, with some exceptions.
  • Have active or prior autoimmune or inflammatory disorders, with some exceptions.
  • Have uncontrolled illnesses, such as infections requiring antibiotics, heart failure, or psychiatric conditions that would interfere with the study.
  • Have interstitial lung disease or active pneumonitis requiring treatment with steroids.
  • Have received a live vaccine within 30 days before starting the study medication.
  • Have had a stem cell or organ transplant.
  • Have known HIV, active hepatitis B, or C.
  • Are pregnant or breastfeeding.
  • Are unwilling to use highly effective contraception during the study and for six months after the last treatment.

Locations

FACILITYZIPCITYSTATE
Weill Cornell Medicine10065New YorkNew York

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