108
Participants
Start Date
August 8, 2025
Primary Completion Date
March 8, 2028
Study Completion Date
July 8, 2028
PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy
For non-squamous NSCLC patients:Pemetrexed (500 mg/m2) plus carboplatin (AUC5) or cisplatin(75 mg/m²)on Day 1 of 21day cycles (every 3 weeks) , followed by PLB1004 80mg/160mg/240mg oral once daily。 For squamous NSCLC subjects: Docetaxel(75 mg/m² )or paclitaxel(175 mg/mg) plus carboplatin (AUC5) or cisplatin(75 mg/m²)on Day 1 of 21day cycles (every 3 weeks) , followed by PLB1004 80mg/160mg/240mg oral once daily.
PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy
Multiple doses of PLB1004 for oral administration. Platinum-based chemotherapy is combined and administered on Day 1 of 21days(every 3 weeks).
RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy
RP2D of PLB1004 as determined during Phase Ib . Platinum-based chemotherapy is combined and administered on Day 1 of 21days(every 3 weeks).
RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy
RP2D of PLB1004 as determined during Phase Ib,patients will undergo surgical treatment after 3 cycles of combination therapy with platinum-based chemotherapy. Post-surgery, they will receive an additional cycle of platinum-based chemotherapy followed by 13 cycles of maintenance therapy with PLB1004.
Shanghai Chest hospital, Shanghai
Avistone Pharmaceutical(Ningbo)Co., LTD.
INDUSTRY