drugset / Trial / NCT05358691
A Trial of AN0025 With Chemoradiation Therapy in Stage III NSCLC Participants
Phase 1
Withdrawn
Rutgers, The State University of New Jersey
Adlai Nortye Biopharma Co., Ltd. · collab
Non-randomizedSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2024-11-01
- Primary completion
- 2027-12-01
- Completion
- 2028-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PALUPIPRANT | Small molecule | 250 mg | Oral |
| Subject | PALUPIPRANT | Small molecule | 375 mg | Oral |
| Background | Durvalumab | Monoclonal antibody | — | — |