Your session is about to expire
← Back to Search
AN0025 + Chemoradiation for Lung Cancer
Phase 1
Waitlist Available
Led By Salma K Jabbour, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a new drug, AN0025, for treating cancer. The drug will be given to patients in two different ways: after chemoradiation therapy, and during chemoradiation therapy. The trial will measure how well the drug works by looking at how long patients live without the cancer progressing, the percentage of patients whose cancer shrinks, and other measures.
Who is the study for?
This trial is for adults over 18 with Stage III Non-Small Cell Lung Cancer who can perform daily activities, have adequate organ function and lung capacity. They must not be pregnant or breastfeeding, agree to use contraception, and cannot have a second active cancer or severe allergies to the treatment components.Check my eligibility
What is being tested?
The trial tests AN0025's safety and effectiveness when given during and after chemoradiation therapy in patients with Stage III NSCLC. It looks at how well it works by measuring time without disease progression, response rate, survival times, and drug levels in the body.See study design
What are the potential side effects?
While specific side effects of AN0025 are not listed here, common ones from similar treatments include fatigue, nausea, skin reactions from radiation, immune-related conditions due to immunotherapy drugs like durvalumab (which may also be part of this study), as well as potential blood count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do my usual activities or only light work due to my condition.
Select...
I am using two birth control methods or am not having sex to join this study.
Select...
I am 18 years old or older.
Select...
I do not have any other ongoing cancers.
Select...
I have provided a sample of my tumor that has not been treated with radiation.
Select...
My lung cancer is advanced and cannot be removed by surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Eastern Cooperative Oncology Group Performance Status (ECOGPS) to measure how participants disease is progressing
Secondary outcome measures
Immune response evaluation criteria in solid tumors( iRECIST) to measure the progression of disease
Other outcome measures
Neoplasms
Side effects data
From 2022 Phase 3 trial • 867 Patients • NCT0308447126%
Asthenia
20%
Anaemia
20%
Constipation
17%
Decreased appetite
16%
Diarrhoea
15%
Nausea
13%
Pruritus
10%
Urinary tract infection
10%
Cough
10%
Fatigue
9%
Vomiting
9%
Dyspnoea
9%
Back pain
9%
Oedema peripheral
9%
Pyrexia
7%
Haematuria
7%
Abdominal pain
7%
Arthralgia
7%
Hypothyroidism
6%
Blood creatinine increased
5%
Weight decreased
2%
Sepsis
1%
Pneumonia
1%
Tumour hyperprogression
1%
General physical health deterioration
1%
Death
1%
Acute kidney injury
1%
Pyelonephritis
1%
Device related infection
1%
Urosepsis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab
Trial Design
2Treatment groups
Experimental Treatment
Group I: AN0025: Dose level two: 375 mg dailyExperimental Treatment1 Intervention
Oral, given two hours before chemotherapy or durvalumab; Patients should fast two hours before and one hour after AN0025 administration
Group II: AN0025: Dose level one: 250 mg dailyExperimental Treatment1 Intervention
Oral, given two hours before chemotherapy or durvalumab; Patients should fast two hours before and one hour after AN0025 administration
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,208 Total Patients Enrolled
Adlai Nortye Biopharma Co., Ltd.Industry Sponsor
7 Previous Clinical Trials
716 Total Patients Enrolled
Salma K Jabbour, MDPrincipal InvestigatorRutgers Cancer Institute of New Jersey
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of lung scarring or fibrosis.I do not have serious heart problems like recent heart failure or uncontrolled high blood pressure.I can do my usual activities or only light work due to my condition.I agree to use contraception or abstain from sex during and for 120 days after treatment.My lungs are working well.I am using two birth control methods or am not having sex to join this study.I weigh less than 66 lbs.I have an autoimmune disease treated with medication in the last 2 years.My cancer has spread to my brain or spinal cord.I am 18 years old or older.I do not have any other ongoing cancers.I have provided a sample of my tumor that has not been treated with radiation.I am currently being treated for an infection.I am a woman who can have children and have a recent negative pregnancy test.I have not had major surgery in the last 4 weeks.My other organs are functioning well.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.I am under 18 years old.My cancer's stage has been properly identified.I have not received a live vaccine in the last 30 days.I stopped an immunotherapy treatment due to severe side effects.I have inflammatory bowel disease.I have received a transplant from another person.I have had or currently have lung inflammation treated with steroids.I cannot take pills by mouth or have uncontrolled stomach issues.My lung cancer is advanced and cannot be removed by surgery.
Research Study Groups:
This trial has the following groups:- Group 1: AN0025: Dose level two: 375 mg daily
- Group 2: AN0025: Dose level one: 250 mg daily
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation currently recruiting participants?
"Confirmed. According to clinicaltrials.gov, this study is no longer actively seeking candidates since the last edit was made on November 2nd 2022. Although recruitment for this trial has been paused, there are 5 other trials that are currently enrolling patients at present."
Answered by AI
What risks could individuals face if exposed to AN0025?
"As AN0025 is in its initial trial state, there is limited data available to support both safety and efficacy. Thus, it received a score of 1 on our scale of risk assessment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger