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New treatment option for Non-small Cell Lung Cancer (NSCLC)
Official title 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)
ClinicalTrials.gov ID: NCT06694454
What this study is testing
What is azacytidine?
azacytidine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer (nsclc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Histologically or cytologically confirmed, resectable per standard of care stage IB-IIIA non-small cell lung cancer (NSCLC) irrespective of...
- Willingness to undergo tumor resection surgery per standard of care (SOC) guidelines following induction therapy (platinum chemotherapy and...
- Participants must have disease that can be safely accessed via bronchoscopic, thoracoscopic, or percutaneous biopsy techniques, and be willing to...
- No prior therapy for the NSCLC.
- Measurable disease per RECIST 1.1
You likely can't join if
- Medically inoperable because of clinical co-morbidities.
- Participants with T4 tumors invading the diaphragm, mediastinum, carina, trachea, esophagus, heart, great vessels, recurrent laryngeal nerve, or...
- Participants who experienced serious immune adverse events that required discontinuation of immune checkpoint inhibitor therapy for a prior non-NSCLC...
- History of known EGFR or ALK alterations in the tumor.
- History of active autoimmune disease including colitis, nephritis, hypophysitis, or neuropathy, with the exceptions of: --Diabetes type I, vitiligo...
- History of pneumonitis or interstitial lung disease.
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed, resectable per standard of care stage IB-IIIA non-small cell lung cancer (NSCLC) irrespective of programmed death-ligand 1 (PD-L1) expression. Note: Confirmation is required by...
- Willingness to undergo tumor resection surgery per standard of care (SOC) guidelines following induction therapy (platinum chemotherapy and durvalumab).
- Participants must have disease that can be safely accessed via bronchoscopic, thoracoscopic, or percutaneous biopsy techniques, and be willing to undergo tumor biopsy before treatment.
- No prior therapy for the NSCLC.
- Measurable disease per RECIST 1.1
- Age \>= 18 years.
- Body weight \> 30kg.
- ECOG Performance Status \<= 1
- Participants must have adequate pulmonary reserve evidenced by predicted post-op FEV1 and adjusted DLCO \>= 40% at screening.
- Participants must have pCO2 \ =60 on room air by arterial blood gas (ABG) if O2 sat by pulse oximetry is\<= 92% on room air at screening.
- Adequate organ and marrow function as defined below:
- Leukocytes \>3,000/microL
- Absolute neutrophil count \>1,500/microL (without transfusion or cytokine support)
- Absolute lymphocyte count \> 800/microL
- Platelets \>100,000/microL
- Hemoglobin \>= 9.0 g/dL
- Prothrombin time (PT) no more than 2 seconds above the upper limit of normal (ULN)
- Total bilirubin OR Direct bilirubin \ = 1.5 ULN
- Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) \< 2.5 X institutional ULN
- Serum albumin \>= 2.0 mg/dL
- Creatinine OR Creatinine clearance (eGFR) \ 60 mL/min/1.73 m\^2 for participants with creatinine levels above institutional normal
- Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of the study...
- Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 3 months after the last dose of the study drug(s).
- Participants with history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness are included if on appropriate antiretroviral therapy with HIV viral load \<400 copies/mL.
- Participants must agree to not donate blood from the study entry and up to 3 months after the last dose of the study drug(s).
- Participants must be co-enrolled in protocol 06C0014: Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies .
- The ability of a participant to understand and the willingness to sign a written informed consent document.
What rules you out
- Medically inoperable because of clinical co-morbidities.
- Participants with T4 tumors invading the diaphragm, mediastinum, carina, trachea, esophagus, heart, great vessels, recurrent laryngeal nerve, or vertebral body.
- Participants who experienced serious immune adverse events that required discontinuation of immune checkpoint inhibitor therapy for a prior non-NSCLC malignancy.
- History of known EGFR or ALK alterations in the tumor.
- History of active autoimmune disease including colitis, nephritis, hypophysitis, or neuropathy, with the exceptions of: --Diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring...
- History of pneumonitis or interstitial lung disease.
- Clinically significant cardiovascular/cerebrovascular disease as follows:
- cerebral vascular accident/stroke (within 6 months prior to study treatment initiation)
- myocardial infarction (within 6 months prior to study treatment initiation)
- unstable angina, congestive heart failure (New York Heart Association Classification Class \>= II...
- Active Hepatitis A (HAV), Hepatitis B (HBV) (HbsAg reactive), or Hepatitis C (HCV) (HCV RNA [qualitative] is detected) at screening.
- Other active infections requiring systemic therapy at screening.
- Positive beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.
- Systemic corticosteroids at doses above physiologic levels (\> 10 mg of prednisone or equivalent per day), or inhaled corticosteroids within 14 days before study treatment initiation. Administration of steroids through...
- Major surgical procedure within 28 days prior to the study treatment initiation. Note: Local surgery of isolated lesions for palliative intent is acceptable provided other site(s) of disease is available for response...
- History of allogenic organ transplantation.
- History of another primary malignancy except for malignancy treated with curative intent and with no known active disease \>= 5 years before the study treatment initiation.
- Administration of live attenuated vaccines within 30 days prior to study treatment initiation. Note: Administration of inactivated vaccines (e.g., inactivated influenza vaccines) is permitted before or during the study.
- Administration of investigational drug on other clinical trial within 14 days prior to study treatment initiation.
- History of hypersensitivity to Mannitol.
- Herbal and natural remedies that may have immune-modulating effects within 7 days prior to study treatment initiation.
- Uncontrolled intercurrent illness evaluated by history and physical exam or situation that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.