Ozmosi | Andamertinib Drug Profile
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Andamertinib

Alternative Names: Andamertinib, plb-1004, plb 1004, plb1004
Clinical Status: Active
Latest Update: 2025-12-16
Latest Update Note: Clinical Trial Update

Product Description

Avistone Biotechnology is developing PLB-1004, an oral EGFR inhibitor being studied in patients with non-small cell lung cancer. (Sourced from: https://clinicaltrials.gov/ct2/show/NCT05347628?term=PLB-1004&draw=2&rank=1)

Mechanisms of Action: EGFR Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Avistone Biotechnology
Company Location:
Company CEO:
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Andamertinib

Countries in Clinic: China, United States

Active Clinical Trial Count: 12

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Non-Small-Cell Lung Cancer

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT06281964

PLB1004-III-01

P3

Enrolling by invitation

Non-Small-Cell Lung Cancer

2026-01-30

13%

2025-06-14

Primary Endpoints|Start Date|Treatments|Trial Status

CTR20201030

CTR20201030

P1

Completed

Non-Small-Cell Lung Cancer

2024-07-31

2025-04-29

Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status

CTR20241361

CTR20241361

P1

Completed

Non-Small-Cell Lung Cancer

2024-05-29

2025-04-29

Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status

CTR20233128

CTR20233128

P1

Completed

Non-Small-Cell Lung Cancer

2023-12-27

2025-04-29

NCT07063329

PLB1004 +Chemo-NSCLC-Ib/II-01

P2

Not yet recruiting

Non-Small-Cell Lung Cancer

2028-03-08

2%

2025-07-15

Primary Endpoints|Treatments

NCT06343064

KYLIN-1

P2

Recruiting

Non-Small-Cell Lung Cancer

2026-12-31

12%

2025-05-21

Primary Endpoints

NCT06574347

PLB1001/PLB1004-NSCLC-II-02

P2

Recruiting

Non-Small-Cell Lung Cancer

2026-10-31

12%

2024-08-28

CTR20231534

CTR20231534

P2

Completed

Non-Small-Cell Lung Cancer

2025-03-10

2025-04-29

Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status

NCT06015503

KANNON

P2

Recruiting

Non-Small-Cell Lung Cancer

2025-03-06

2%

2025-04-04

CTR20241781

CTR20241781

P2

Recruiting

Non-Small-Cell Lung Cancer

None

2025-04-29

Patient Enrollment|Start Date|Treatments|Trial Status

NCT06046495

PLB1004-I-US01

P1

Recruiting

Non-Small-Cell Lung Cancer

2028-02-09

12%

2024-07-24

NCT06970782

PLB1001/PLB1004-NSCLC-III-01

P3

Not yet recruiting

Non-Small-Cell Lung Cancer

2027-12-31

58%

2025-05-15

Primary Endpoints|Treatments