A Trial of AN0025 With Chemoradiation Therapy in Stage III NSCLC Participants

NCT05358691 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: 032303Pro2022000665
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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

Conditions

Lung Cancer Stage III

Keywords

Chemoradiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  Two years

Secondary Outcomes (1)

• Immune response evaluation criteria in solid tumors( iRECIST) to measure the progression of disease

  2 years

Other Outcomes (1)

• Response evaluation criteria in solid tumors (RECIST 1.1) will be used as the primary measure for tumor response

  2 Years

Study Arms (2)

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

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

Drug: AN0025

Interventions

AN0025 DRUG

To evaluate the safety and preliminary efficacy of AN0025 in combination with chemoradiation + consolidation durvalumab in Stage III Non-Small Cell Lung Cancer participants

Also known as: Platinum-based chemotherapy, Radiation, Durvalumab

AN0025: Dose level one: 250 mg daily; AN0025: Dose level two: 375 mg daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Adlai Nortye Biopharma Co., Ltd.: collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Platinum Compounds; Radiation; durvalumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Physical Phenomena

Study Officials

• Salma K Jabbour, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Vice Chair of Clinical Research and Faculty Development, Department of Radiation Oncology; Clinical Chief of the Radiation Oncology Clinic

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)