Study on Pembrolizumab After Radiation and Chemotherapy for Limited Stage Small Cell Lung Cancer

Sponsor: Vanderbilt-Ingram Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06140407

Provider View

This clinical trial is testing whether adding the immunotherapy drug pembrolizumab after standard treatment with radiation and chemotherapy can help the immune system better fight limited stage small cell lung cancer (LS-SCLC).

Patient Parameters

Program Overview

This study is exploring if pembrolizumab, an immunotherapy drug, can improve treatment outcomes for patients with limited stage small cell lung cancer (LS-SCLC) when given after standard treatment with radiation and chemotherapy drugs like cisplatin or carboplatin, and etoposide. Pembrolizumab may help the immune system attack cancer cells and prevent them from growing and spreading. The trial aims to see if this approach can enhance the body's ability to fight LS-SCLC.

Description

The main goal of this study is to see how long patients with limited stage small cell lung cancer (LS-SCLC) can live without the cancer getting worse when treated with pembrolizumab after standard therapy. Researchers will also look at overall survival rates compared to past data and assess the safety of pembrolizumab.

Participants will first receive radiation therapy and chemotherapy with cisplatin or carboplatin and etoposide. After completing this standard treatment, they will receive pembrolizumab through an IV every 21 days for up to a year, as long as the cancer does not progress or cause severe side effects. Throughout the study, participants will undergo various scans and blood tests to monitor their health and the treatment's effects.

After finishing the study treatment, participants will have follow-up visits at 30 days and every 12 weeks for two years to check on their health and any changes in their condition.

Eligibility Criteria

Inclusion Criteria

  • Have limited stage small cell lung cancer (LS-SCLC) that has not spread extensively.
  • Be at least 18 years old with a confirmed diagnosis of small cell lung cancer or high-grade neuroendocrine carcinoma.
  • Agree to use effective contraception during the study and for 120 days after the last dose of pembrolizumab if of childbearing potential.
  • Not show any signs of cancer progression after completing initial treatment with radiation and chemotherapy.
  • Provide written informed consent to participate in the trial.
  • Have a good performance status, meaning fully active or able to carry out light work.
  • If positive for hepatitis B, must be on antiviral therapy with an undetectable viral load.
  • If previously infected with hepatitis C, must have an undetectable viral load.
  • If HIV-positive, must have well-controlled HIV with a stable antiretroviral therapy regimen.
  • Meet specific blood count and organ function criteria based on recent tests.

Exclusion Criteria

  • Have received prior treatment with pembrolizumab or similar drugs.
  • Have had other cancer treatments or participated in another clinical trial recently.
  • Have received a live vaccine within 30 days before starting the study.
  • Have an immune deficiency or are on high-dose steroids or other immunosuppressive drugs.
  • Have another active cancer that requires treatment.
  • Have active brain metastases or cancer in the brain lining.
  • Have severe allergies to pembrolizumab.
  • Have an autoimmune disease needing treatment in the past two years.
  • Have a history of lung disease requiring steroids.
  • Have an active infection needing treatment.
  • Are pregnant, breastfeeding, or planning to conceive during the study.
  • Have had a tissue or organ transplant.
  • Have any condition or situation that might interfere with the study or participant's safety.
  • Have psychiatric or substance abuse issues that could affect participation.
  • Have a history of certain HIV-related conditions.

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