Study on Chemotherapy and Immunotherapy After Surgery for Small Cell Lung Cancer

Sponsor: Alliance Foundation Trials, LLC.

Sponsor score: 0

ClinicalTrials ID:NCT07149363

Provider View

This phase II clinical trial is testing the effectiveness and safety of combining chemotherapy and immunotherapy for patients who have had surgery to remove small cell lung cancer (SCLC).

Patient Parameters

Program Overview

This study is exploring a treatment approach that combines chemotherapy and immunotherapy for patients who have had surgery to completely remove small cell lung cancer (SCLC). The goal is to see if this combination can improve the chances of staying cancer-free for two years after treatment. The trial is open-label, meaning both doctors and participants know what treatment is being given, and it is conducted across multiple centers.

Description

This phase II study is designed to evaluate how well a combination of chemotherapy and immunotherapy works for patients who have had surgery to remove small cell lung cancer (SCLC). The study focuses on patients with specific stages of SCLC (T1-T2, N0-N1, M0) who have not received any prior systemic treatments for this cancer. The treatment aims to improve the chances of remaining cancer-free for two years. Participants will receive the treatment after surgery, and the study will monitor their health and any side effects to ensure the treatment is safe and effective.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Weigh more than 30 kg (about 66 pounds).
  • Have a life expectancy of at least 12 weeks.
  • Have a confirmed diagnosis of small cell lung cancer (SCLC) at specific stages (T1-T2, N0-N1, M0) according to medical guidelines.
  • Have had surgery to completely remove the lung cancer within 78 days before joining the study.
  • Have had a complete examination of the lymph nodes in the chest area during surgery.
  • Have not received any prior systemic treatments for SCLC.
  • Post-surgery radiation is allowed if recommended by the doctor for certain cases, but no other prior radiation for SCLC.
  • 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.

Exclusion Criteria

  • Currently participating in another clinical trial for small cell lung cancer.
  • Have received prior treatment with the immunotherapy drug durvalumab.
  • Have a history of another cancer, unless it was treated successfully and has been inactive for at least two years, or is a type of cancer with a low risk of returning.
  • Have had a stroke, mini-stroke, blood clot in the lungs, or untreated deep vein thrombosis in the past three months.
  • Have coughed up more than 2.5 mL of blood in the two weeks before starting the study treatment.
  • Need to take certain medications like phenytoin, phenobarbital, or carbamazepine.

Locations

FACILITYZIPCITYSTATE
University of Virginia Comprehensive Cancer Center22908CharlottesvilleVirginia

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