CHIO3 Trial: Combining Chemotherapy and Immunotherapy for Treatable Stage IIIA/B Non-Small Cell Lung Cancer

Sponsor: Alliance Foundation Trials, LLC.

Sponsor score: 0

ClinicalTrials ID:NCT04062708

Provider View

This study is testing a combination of chemotherapy and an immune therapy drug, durvalumab, before surgery for patients with treatable stage IIIA/B non-small cell lung cancer (NSCLC). The goal is to improve the clearance of cancer from lymph nodes compared to chemotherapy alone.

Patient Parameters

Program Overview

This trial is exploring a treatment plan for patients with stage IIIA/B non-small cell lung cancer (NSCLC) that can potentially be removed by surgery. The plan includes chemotherapy combined with an immune therapy drug called durvalumab before surgery, followed by radiation and more durvalumab after surgery. The main aim is to increase the rate of clearing cancer from the lymph nodes to 50% or more, compared to the historical rate of 30% with chemotherapy alone.

Description

In this study, patients who are eligible for surgery will first receive a combination of chemotherapy and the immune therapy drug durvalumab. This treatment is given every three weeks before surgery. After surgery, patients will receive radiation therapy within 4 to 10 weeks. Following radiation, patients will continue to receive durvalumab every four weeks for one year.

Patients will have imaging tests before surgery and at specific intervals after surgery to monitor the cancer. If surgery is not possible due to various reasons, patients will stop the study treatment. Regular follow-up imaging will occur every 12 weeks for the first two years, then every six months for the next three years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a good performance status (able to carry out daily activities).
  • Expected to live at least 12 more weeks.
  • Have stage IIIA/B non-small cell lung cancer that can potentially be removed by surgery.
  • Must be evaluated by a thoracic surgeon within four weeks of joining the study.
  • Must have adequate health to undergo major lung surgery.
  • Cancer in lymph nodes must be less than 3 cm and not invading other structures.
  • Must have measurable cancer according to specific criteria.
  • Must have a confirmed diagnosis of cancer in the lymph nodes within four weeks of joining the study.
  • Must not have had previous thoracic radiation.
  • Must have adequate organ and bone marrow function.
  • Must be able to give informed consent.
  • Women must not be pregnant or nursing and must use effective birth control.
  • Men must agree to use contraception during and after the study.

Exclusion Criteria

  • Any previous treatment for non-small cell lung cancer.
  • Previous thoracic radiation.
  • Significant nerve damage.
  • Active or history of autoimmune diseases, except for certain conditions like vitiligo.
  • Use of systemic steroids or immunosuppressive medications recently.
  • History of other cancers unless in complete remission for at least two years.
  • History of organ transplant.
  • Cancer spread to certain lymph nodes (N3 nodal disease).
  • Mixed small cell and non-small cell lung cancer.
  • Pregnant or breastfeeding.
  • History of severe allergic reactions to similar drugs.
  • Uncontrolled health conditions that could interfere with the study.
  • Certain heart conditions.

Locations

FACILITYZIPCITYSTATE
NorthWestern University60611ChicagoIllinois
University of Chicago Medical Center60637ChicagoIllinois
Massachusetts General Hospital02114BostonMassachusetts
Brigham and Women's Hospital02115BostonMassachusetts
Lowell General Hospital01854LowellMassachusetts
SUNY Upstate Medical University13210SyracuseNew York
Baptist Cancer Center38120MemphisTennessee
University of Texas MD Anderson Cancer Center77030HoustonTexas
University of Virginia Health System22908CharlottesvilleVirginia

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