A Trial of AN0025 With Chemoradiation Therapy in Stage III NSCLC Participants
Primary * Evaluate safety and toxicity of AN0025 in both the consolidative setting (after chemoradiation) and in the concurrent setting (during chemoradiation) * Evaluate efficacy by progression-free survival (PFS), objective response rate (ORR), and time to death or distant metastasis (TTMD), Duration of response (DOR), Overall survival (OS) with the addition of AN0025 in both the consolidative and concurrent settings Exploratory * Evaluate pharmacokinetics of AN0025 in conjunction with chemoradiation, and then with durvalumab
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 16, 2025 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Rutgers, The State University of New Jersey
- Interventions being studied
- Drug: AN0025
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Be willing and able to provide written informed consent for the trial
- Age 18 years or greater
- Be fully active, able to carry on all pre-disease performance without restriction or restricted in physically strenuous activity but able to carry out work of a light or sedentary nature (e.g., light house work, office work)
- Be diagnosed with confirmed locally advanced and nonresectable, or metastatic Stage III Non-Small Cell Lung Cancer
- Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
- Adequate staging of your disease
- Adequate lung function
- Adequate other organ functions
- No active second cancers
- Be willing and able to comply with all aspects of the protocol
- Female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication
- Female participants of childbearing potential should be willing to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
- Male participants should agree to abstinence or use of an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
- Age less than 18 years
- Weight less than 30 Kg (\~66 lbs)
- Pregnant or breastfeeding women
- Have been discontinued in a prior treatment study with immunotherapy drugs due to a severe toxicity (Grade 3 or higher)
- Received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- Had an allogenic tissue/solid organ transplant
- A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within seven days prior to the first dose of study drug
- Known active cancer spread to central nervous system
- Known severe hypersensitivity to study treatment components
- An active autoimmune disease that has required systemic treatment in the past two years
- Have inflammatory bowel disease
- Have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis
- Have a history of interstitial lung disease
- Have an active infection requiring systemic therapy
- Have human immunodeficiency virus (HIV) and/or history of Hepatitis B or C infections,
- Have abnormal electrocardiogram (Prolongation of QT interval)
- Significant cardiovascular impairment: history of congestive heart failure, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac arrhythmia
- Major surgery within four weeks before the first dose of study drug
- Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (eg, nausea, diarrhea, or vomiting)
- Have a known psychiatric or substance abuse problems
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 16, 2025. Always confirm current availability with the study team.