Study on Chemo-Immunotherapy and Surgery for Advanced Non-Small Cell Lung Cancer with Lymph Node Involvement

Sponsor: Georgetown University

Sponsor score: 40

ClinicalTrials ID:NCT06449313

This clinical trial is exploring whether a combination of chemotherapy and immunotherapy, followed by surgery, can effectively treat stage 3 non-small cell lung cancer (NSCLC) that has spread to certain lymph nodes. The study will also look at the benefits of continuing immunotherapy after surgery.

Patient Parameters

Program Overview

The aim of this study is to find out if using a combination of chemotherapy and an immunotherapy drug called cemiplimab before surgery can help patients with stage 3 non-small cell lung cancer (NSCLC) that has spread to specific lymph nodes. Participants will receive a combination of chemotherapy and cemiplimab every three weeks for four cycles before surgery. After surgery, they may receive radiation therapy if recommended by their doctors, and will continue to receive cemiplimab every three weeks for one year.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of stage 3 B/C non-small cell lung cancer (NSCLC) with specific lymph node involvement.
  • The primary lung tumor must be suitable for surgery with the goal of curing the cancer.
  • Must not have any major health issues that would make surgery too risky.
  • Must have good lung function to tolerate the planned lung surgery.
  • Must have specific genetic markers (EGFR, ALK) unless the cancer is a certain type (pure squamous NSCLC).
  • Must 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.
  • Must have adequate blood counts and organ function based on specific lab tests.
  • Women of childbearing potential must agree to use effective contraception during the study and for four months after the last treatment.
  • Men must agree to use effective contraception and not donate sperm during the study and for four months after the last treatment.

Exclusion Criteria

  • Have a type of lung cancer that is not suitable for this study, such as large cell neuroendocrine carcinoma or small cell lung cancer.
  • The primary lung tumor is not suitable for surgery.
  • Have received any prior treatment for the current lung cancer.
  • Have had another cancer requiring treatment within the last two years, except for certain low-risk cancers.
  • Have a history of significant autoimmune disease that could be worsened by immunotherapy, with some exceptions for well-controlled conditions.
  • Have certain lung diseases or active lung inflammation.
  • Have active tuberculosis.
  • Have poorly controlled HIV, unless stable on treatment with undetectable viral load and adequate CD4 count.
  • Have poorly controlled hepatitis B or C, unless the infection is well-managed.
  • Have had a severe infection recently that could affect safety.
  • Have had a stem cell or organ transplant.
  • Have received a live vaccine recently or plan to during the study.
  • Have significant heart or blood vessel disease recently.
  • Are taking certain immunosuppressive medications, with some exceptions for low-dose or specific types of steroids.
  • Have used immune checkpoint inhibitors before.
  • Have severe allergies to study drugs.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study or within six months after the last treatment.

Locations

FACILITYZIPCITYSTATE
Lombardi Comprehensive Cancer Center, Georgetown University20007WashingtonDistrict of Columbia

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