Lung Cancer Stage IIIPhase 1NCT05358691
A Trial of AN0025 With Chemoradiation Therapy in Stage III NSCLC Participants
A Phase 1 study testing AN0025 in people with Lung Cancer Stage III, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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 survival (PFS), objective response rate (ORR), and time to death or distant metastasis (TTMD), Duration of response (DOR)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Stage III
- What is being tested?
- AN0025
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 1 Jun 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
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
Read the 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 Cancer. Participant will receive the experimental combination of drugs (AN0025, chemoradiation and durvalumab) and undergo laboratory tests and study procedures on specified days during the study period. Complete end of study evaluations and tests, and participate in post-study follow up every three months for two years. The time in the study will take approximately four to six hours during pre-study, study and end of study visits.
Possible benefits of taking part may be improvement in your condition and slowing or stopping the growth of your cancer.
- Conditions
- Lung Cancer Stage III
- Being tested
- AN0025
- Keywords
- Chemoradiation Therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN0025Drug
Also called Platinum-based chemotherapy, Radiation, Durvalumab
To evaluate the safety and preliminary efficacy of AN0025 in combination with chemoradiation + consolidation durvalumab in Stage III Non-Small Cell Lung Cancer participants
| Study group | Role | What they receive |
|---|---|---|
| AN0025: Dose level one: 250 mg daily | Experimental | Oral, given two hours before chemotherapy or durvalumab; Patients should fast two hours before and one hour after AN0025 administration Receives: Drug: AN0025 |
| AN0025: Dose level two: 375 mg daily | Experimental | Oral, given two hours before chemotherapy or durvalumab; Patients should fast two hours before and one hour after AN0025 administration Receives: Drug: AN0025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eastern Cooperative Oncology Group Performance Status (ECOGPS) to measure how participants disease is progressing
The performance status will be assessed according to the Eastern Cooperative Oncology Group Performance Status (ECOG) performance status scale. Eastern Cooperative Oncology Group Performance Status (ECOG) will be measured at screening, at day one of each treatment cycle and at the safety follow-up visits
Measured: Two years
Secondary outcomes (1)
Immune response evaluation criteria in solid tumors( iRECIST) to measure the progression of disease
A solid tumor measurement and definitions for objective change in tumor size. Immune response evaluation criteria in solid tumors (iRECIST) is based on RECIST 1.1, but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST will be used by the Investigator to assess tumor response and progression and make treatment decisions.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Nov 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Why it stopped: The research was cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer Stage IIIStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is an open-label, multicenter, phase 1 study to evaluate the safety and preliminary efficacy of AN0025 in combination with chemoradiation + consolidation Durvalumab therapy in patients with locally advanced Stage III NSCLC. The Phase 1a part will include dose escalations or de-escalation in three dose cohorts and a dose-limiting toxicity observation period. The Phase 1b part will be an expansion phase with twelve participants (including those enrolled at the MTD) at the recommended Phase 2 dose (RP2D) or the maximum tolerated dose level.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Adlai Nortye Biopharma Co., Ltd.
- Responsible party
- Principal investigator, Salma Jabbour, MD, Rutgers, The State University of New Jersey
- Investigators
- Salma K Jabbour, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358691
- Sponsor's protocol ID
- 032303
- Other IDs
- Pro2022000665
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2022
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of AN0025 With Chemoradiation Therapy in Stage III NSCLC Participants
- ClinicalTrials.gov ID
- NCT05358691
- Acronym / sponsor ID
- 032303
- Conditions
- Lung Cancer Stage III
- Keywords
- Chemoradiation Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The research was cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Adlai Nortye Biopharma Co., Ltd.
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 Cancer. Participant will receive the experimental combination of drugs (AN0025, chemoradiation and durvalumab) and undergo laboratory tests and study procedures on specified days during the study period. Complete end of study evaluations and tests, and participate in post-study follow up every three months for two years. The time in the study will take approximately four to six hours during pre-study, study and end of study visits.
Possible benefits of taking part may be improvement in your condition and slowing or stopping the growth of your cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, multicenter, phase 1 study to evaluate the safety and preliminary efficacy of AN0025 in combination with chemoradiation + consolidation Durvalumab therapy in patients with locally advanced Stage III NSCLC. The Phase 1a part will include dose escalations or de-escalation in three dose cohorts and a dose-limiting toxicity observation period. The Phase 1b part will be an expansion phase with twelve participants (including those enrolled at the MTD) at the recommended Phase 2 dose (RP2D) or the maximum tolerated dose level.
| Arm | Type | Receives |
|---|---|---|
| AN0025: Dose level one: 250 mg daily | Experimental | Drug: AN0025Oral, given two hours before chemotherapy or durvalumab; Patients should fast two hours before and one hour after AN0025 administration |
| AN0025: Dose level two: 375 mg daily | Experimental | Drug: AN0025Oral, given two hours before chemotherapy or durvalumab; Patients should fast two hours before and one hour after AN0025 administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AN0025Also: Platinum-based chemotherapy, Radiation, DurvalumabTo evaluate the safety and preliminary efficacy of AN0025 in combination with chemoradiation + consolidation durvalumab in Stage III Non-Small Cell Lung Cancer participants | Drug | AN0025: Dose level one: 250 mg daily, AN0025: Dose level two: 375 mg daily |
Primary outcome
Eastern Cooperative Oncology Group Performance Status (ECOGPS) to measure how participants disease is progressing
Time frame: Two years
The performance status will be assessed according to the Eastern Cooperative Oncology Group Performance Status (ECOG) performance status scale. Eastern Cooperative Oncology Group Performance Status (ECOG) will be measured at screening, at day one of each treatment cycle and at the safety follow-up visits
1 secondary outcome
Immune response evaluation criteria in solid tumors( iRECIST) to measure the progression of disease
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer Stage III
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingPhase 3
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.
Non Small Cell Lung Cancer
Not yet recruiting
Moderately Hypofractionated Versus Conventional Chemoradiotherapy With Consolidation Immunotherapy in Patients With Unresectable, Non-Targetable Stage III Non Small Cell Lung Cancer (NSCLC)
Stage III NSCLC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salma K Jabbour, MD principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AN0025 in people with Lung Cancer Stage III, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eastern Cooperative Oncology Group Performance Status (ECOGPS) to measure how participants disease is progressing (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.