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NCT06694454 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT06694454: Recruiting Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT06694454 is a Phase 1 study that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06694454, a Phase 1 study, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
Background: Lung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Surgery to remove the tumors is the standard treatment for people diagnosed with early stages of NSCLC. Despite complete removal of these tumors, many recur (happen again). An FDA-approved drug combination to treat early-stage NSCLC prior to the surgery is durvalumab plus standard chemotherapy. The FDA approved infusion drug azacytidine \[AZA\] is used to treat several diseases because it can rapidly kill dividing cells (including cancer cells) but it is not approved for NSCLC. An inhaled (aerosolized) form of AZA is also not approved for NSCLC. However, researchers want to know if an inhaled version of AZA can help improve treatment of people with NSCLC because inhaled AZA goes directly into the lungs with limited absorption into the bloodstream. Objective: To find the safest and most effective dose of inhaled AZA in participants with early-stage non-small cell lung cancer (NSCLC) that can still be removed by surgery. Eligibility: Adults aged 18 and older with operable early-stage NSCLC. Participants will be required to also enroll in NIH protocol 06C0014 which allows for pre- and post-treatment biopsies and bloodwork to be obtained for additional research studies. Design: Participants will be screened. They will have a physical exam with blood tests. Their medical records will be reviewed. They will have imaging scans and tests of their heart and lung functions. Participants will be required to have a tissue sample (biopsy) taken of their tumor prior to receiving study drug and again during surgery after Cycle 3; airway tissue biopsies and collection of collect bronchial (lung) fluid may also be done. Participants will receive the study treatment for 3 cycles. Each cycle is 21 days. They will need to come to the NIH Clinical Center (CC) on days 1-4 of Cycles 1-3. AZA will be given as a drug mist that ca
Interventions
- DRUG durvalumab
- DRUG cisplatin
- DRUG carboplatin
- DRUG paclitaxel
- DRUG azacytidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-07-15 |
| Est. Completion | 2034-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06694454
The ClinicalTrials.gov registry entry for NCT06694454 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which durvalumab is the first listed.
NCT06694454 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06694454 about?
NCT06694454 is a clinical study titled "Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)". Background: Lung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Surgery to remove the tumors is the standard treatment for people diagnosed with early stages of NSCLC. Despite complete removal of these tumors...
What is the current status of trial NCT06694454?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2026-07-15. Estimated completion is 2034-12-31.
What interventions are being tested in trial NCT06694454?
The interventions under investigation include: durvalumab (DRUG), cisplatin (DRUG), carboplatin (DRUG), paclitaxel (DRUG), azacytidine (DRUG).
Who is sponsoring clinical trial NCT06694454?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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