drugset / Trial / NCT07063329

Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive

NCT07063329

Phase 1/2 Not yet recruiting 108 enrolled Avistone Pharmaceutical (Ningbo) Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

Tyrosine Kinase Inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with EGFR-TKI, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining PLB1004 with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer. In recent years, clinical studies on the combination of EGFR-TKI and chemotherapy have made important progress, suggesting that the combination of EGFR-TKI and chemotherapy further enhances the therapeutic benefit in EGFR-mutant positive NSCLC. Both preclinical and clinical data indicate that PLB1004 exhibit good antitumor activity and relatively durable efficacy in NSCLC patients with EGFR mutations. They can reduce tumor burden, control tumor progression, and improve the survival benefit of patients, which is expected to provide an effective treatment option for such patients.

Timeline

Start
2025-08-08
Primary completion
2028-03-08
Completion
2028-07-08

Drugs

EvaluationDrugModalityDoseRoute
Subject PLB1004 Small molecule 80 mg Oral
Subject PLB1004 Small molecule 160 mg Oral
Subject PLB1004 Small molecule 240 mg Oral
Background Carboplatin Small molecule 5 unknown
Background Cisplatin Other / unclassified 75 mg/m2
Background Docetaxel Small molecule 75 mg/m2
Background Paclitaxel Small molecule 175 unknown
Background Pemetrexed Small molecule 500 mg/m2