Study on Inhaled Azacytidine with Chemotherapy and Immunotherapy for Treating Early-Stage Non-Small Cell Lung Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06694454

Provider View

This clinical trial is testing a new treatment approach for early-stage non-small cell lung cancer (NSCLC) that can be surgically removed. The study combines inhaled azacytidine with standard chemotherapy and the immunotherapy drug durvalumab to see if it can improve treatment outcomes.

Patient Parameters

Program Overview

Lung cancer is a leading cause of cancer-related deaths, with non-small cell lung cancer (NSCLC) being the most common type. Surgery is the standard treatment for early-stage NSCLC, but the cancer often returns. This study is exploring whether inhaled azacytidine, combined with chemotherapy and the immunotherapy drug durvalumab, can improve treatment for early-stage NSCLC. Inhaled azacytidine goes directly to the lungs, potentially reducing side effects. The study aims to find the safest and most effective dose of inhaled azacytidine for patients with operable NSCLC.

Description

This study is investigating a new treatment for early-stage non-small cell lung cancer (NSCLC) that can be surgically removed. The treatment combines inhaled azacytidine with standard chemotherapy and the immunotherapy drug durvalumab. Inhaled azacytidine is not yet approved for NSCLC, but it is being tested to see if it can improve treatment outcomes by targeting the lungs directly and reducing side effects.

Participants in the study will receive the treatment in three cycles, each lasting 21 days. During each cycle, they will inhale azacytidine using a nebulizer for three consecutive days and receive chemotherapy and durvalumab by IV on the fourth day. After completing the treatment cycles, participants will have surgery to remove the tumors.

The study will monitor participants' health and response to the treatment through follow-up visits at the NIH Clinical Center. These visits will occur two weeks after the last treatment dose, and then at regular intervals for up to three years after surgery. The study aims to determine the best dose of inhaled azacytidine and assess its effectiveness in improving treatment outcomes for early-stage NSCLC.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with early-stage non-small cell lung cancer (NSCLC) that can be surgically removed.
  • Willing to undergo surgery to remove the tumor after treatment.
  • No previous treatment for NSCLC.
  • Cancer that can be safely accessed for a biopsy.
  • Good overall health with adequate organ function.
  • Willing to use effective contraception during the study and for a specified period after the last dose of study drugs.
  • Agree to not donate blood during the study and for three months after the last dose of study drugs.
  • Participants with HIV must have a controlled viral load.
  • Willing to sign a consent form and comply with study requirements.

Exclusion Criteria

  • Medical conditions that make surgery unsafe.
  • Tumors that have spread to certain areas like the diaphragm or heart.
  • History of severe immune-related side effects from previous cancer treatments.
  • Known genetic mutations in the tumor that affect treatment.
  • Active autoimmune diseases requiring treatment.
  • Significant heart or blood vessel diseases.
  • Active hepatitis or other infections requiring treatment.
  • Pregnant or breastfeeding women.
  • Recent use of high-dose steroids or certain other medications.
  • Recent major surgery or organ transplant.
  • Participation in another clinical trial within 14 days before starting this study.
  • Allergies to certain components of the study drugs.

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