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

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

August 8, 2025

Primary Completion Date

March 8, 2028

Study Completion Date

July 8, 2028

Conditions
NSCLC (Non-small Cell Lung Cancer)
Interventions
DRUG

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.

DRUG

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).

DRUG

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).

DRUG

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.

Trial Locations (1)

Unknown

Shanghai Chest hospital, Shanghai

All Listed Sponsors
lead

Avistone Pharmaceutical(Ningbo)Co., LTD.

INDUSTRY