Status:
WITHDRAWN
A Trial of AN0025 With Chemoradiation Therapy in Stage III NSCLC Participants
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
Adlai Nortye Biopharma Co., Ltd.
Conditions:
Lung Cancer Stage III
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
The purpose of the research is to evaluate the safety and preliminary efficacy of AN0025 in combination with chemoradiation + consolidation durvalumab in advanced (Stage III) Non-Small Cell Lung Cance...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2028
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05358691
Start Date
November 1 2024
End Date
June 1 2028
Last Update
April 16 2025
Active Locations (1)
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1
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903