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Carcinoma, Non Small Cell Lung / azacytidine / Carboplatin · Phase 1/2 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1/2 trial registration for a novel combination of inhaled azacytidine, durvalumab, and platinum-based chemotherapy in operable early-stage NSCLC. The study is currently recruiting and has not yet reported results. No efficacy or safety data are available from this registry record.
Phase 1/2, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Non-small Cell Lung Cancer (NSCLC), Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Carcinoma, Non Small Cell Lung Cancer, Non Small Cell Lung Carcinoma; age from 18 Years; to 120 Years. Intervention: 1/ Phase I Dose Escalation; 2/ Phase II Dose Expansion. n = 60. 1 site: United States.
This is a Phase 1/2 trial registration for a novel combination of inhaled azacytidine, durvalumab, and platinum-based chemotherapy in operable early-stage NSCLC. The study is currently recruiting and has not yet reported results. No efficacy or safety data are available from this registry record.
No interim or final efficacy or safety data reported in this registry entry. Phase 1 dose-escalation component may limit generalizability of early safety findings.
This trial explores whether inhaled azacytidine can enhance neoadjuvant immunotherapy and chemotherapy in early-stage NSCLC by delivering drug directly to lung tissue with minimal systemic absorption. Results are pending and will inform both safety and efficacy of this novel epigenetic-immunotherapy combination.
This is a Phase 1/2 trial registration with no results posted; the study is actively recruiting and has not yet reported efficacy or safety outcomes.
As stated by the source record.
Quoted from the source exactly as published.
This trial explores whether inhaled azacytidine can enhance neoadjuvant immunotherapy and chemotherapy in early-stage NSCLC by delivering drug directly to lung tissue with minimal systemic absorption. Results are pending and will inform both safety and efficacy of this novel epigenetic-immunotherapy combination.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06694454). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 60 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer (NSCLC), Carcinoma, Non-Small Cell Lung, Non-Small Cell Lung Carcinoma, Non Small Cell Lung Cancer, Non Small Cell Lung Carcinoma. Interventions: DRUG: azacytidine; DRUG: carboplatin; DRUG: paclitaxel; DRUG: durvalumab; DRUG: cisplatin; DRUG: gemcitabine; DRUG: pemetrexed. Primary outcome measures: Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of neoadjuvant aerosolized AZA in participants with operable early-stage NSCLC treated with standard of care (SOC) platinum-based chemotherapy and du... , starts at initiation of study drug, though end of DLT period; Phase II: To determine the frequency of pathologic complete responses (pCR) in participants receiving aerosolized AZA, durvalumab, and SOC platinum-based chemotherapy as induction therapy for early-stage NSCLC , baseline (pre-treatment biopsy), and at the time of SOC surgery post-cycle 3. Brief 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 can be inhaled (like the type of mist in an asthma inhaler) using a nebulizer at the NIH Clinical Center (CC) for 3 days in a row (consecutive days) during the first week of each cycle. The participant will inhale the AZA drug mist for 20 to 30 minutes each time. Participants will also receive durvalumab and a specific 2-drug assigned chemotherapy by intravenous (IV) infusion on day 4 of each cycle. Participants will have a follow-up visit 2 weeks after their last dose of study drugs. Then they will have planned surgery to remove the tumors. Participants will have additional follow-up visits at the NIH CC about 1 and 3 months after the surgery, and then for every 3 months for up to 3 years.
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