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DRUG:

andamertinib (PLB1004)

i
Other names: PLB1004
Associations
Company:
Avistone Biotech
Drug class:
EGFR inhibitor
Related drugs:
Associations
17d
Andamertinib in Advanced Non-Small-Cell Lung Cancer with EGFR Exon 20 Insertions After Platinum-Based Chemotherapy or Immunotherapy: Results from the Phase 2 KANNON Study. (PubMed, J Thorac Oncol)
Andamertinib at 240 mg once daily demonstrated efficacy with a manageable safety profile in previously treated patients with EGFR ex20ins-mutant NSCLC.
P2 data • Journal • IO biomarker
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
|
andamertinib (PLB1004)
1m
Phase III clinical study of EGFR 20 exon insertion mutation in PLB1004 non-small cell lung cancer (ChiCTR2500107929)
P3, N=327, Recruiting, Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci
New P3 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR positive
|
cisplatin • carboplatin • Tyvyt (sintilimab) • pemetrexed • andamertinib (PLB1004)
4ms
New P1/2 trial
|
EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation
|
andamertinib (PLB1004)
6ms
Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion. (clinicaltrials.gov)
P3, N=327, Enrolling by invitation, Avistone Biotechnology Co., Ltd. | Not yet recruiting --> Enrolling by invitation
Enrollment open
|
cisplatin • carboplatin • Tyvyt (sintilimab) • pemetrexed • andamertinib (PLB1004)
7ms
Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI (clinicaltrials.gov)
P1/2, N=156, Recruiting, Avistone Biotechnology Co., Ltd. | Trial completion date: Jun 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2026
Trial completion date • Trial primary completion date
|
bozitinib (APL-101) • andamertinib (PLB1004)
7ms
New P3 trial
|
cisplatin • carboplatin • pemetrexed • bozitinib (APL-101) • andamertinib (PLB1004)
8ms
Kannon: A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC) (clinicaltrials.gov)
P2, N=157, Recruiting, Avistone Biotechnology Co., Ltd. | Trial completion date: Sep 2026 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Mar 2025
Trial completion date • Trial primary completion date
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
andamertinib (PLB1004)
1year
Trial primary completion date • EGFR exon 20 • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
andamertinib (PLB1004)
over1year
New P2 trial • Metastases
|
Tagrisso (osimertinib) • bozitinib (APL-101) • andamertinib (PLB1004)
over1year
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer (clinicaltrials.gov)
P1, N=81, Recruiting, Avistone Biotechnology Co., Ltd. | Active, not recruiting --> Recruiting | Initiation date: Nov 2023 --> Jul 2024
Enrollment open • Trial initiation date
|
EGFR (Epidermal growth factor receptor)
|
andamertinib (PLB1004)
over1year
New P1/2 trial
|
bozitinib (APL-101) • andamertinib (PLB1004)
almost2years
New P3 trial
|
EGFR (Epidermal growth factor receptor)
|
cisplatin • carboplatin • Tyvyt (sintilimab) • pemetrexed • andamertinib (PLB1004)