Efficacy and Safety Evaluation of PLB1004 in Patients With Non-squamous NSCLC Harboring EGFR Exon 20 Insertion.

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

327

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

January 30, 2026

Study Completion Date

December 30, 2026

Conditions
Non-Small-Cell Lung Cancer
Interventions
DRUG

PLB1004

Participants received oral PLB1004 240mg on Day 1 every 3 weeks (q3w), IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 5 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive oral PLB1004 240mg and 500 mg/m\^2 of pemetrexed on Day 1 q3w until disease progression in the maintenance period.

DRUG

Pemetrexed+(carboplatin or Cisplatin)with or without Sintilimab

Participants received IV infusion of 500 milligrams per meter square (mg/m\^2) pemetrexed on Day 1 q3w, and as per investigator's choice either IV infusion of carboplatin on Day 1 q3w with a dose calculated using 'Calvert formula' to obtain area under concentration versus time (AUC) = 5 milligrams per milliliter per minute (mg/mL/min) or IV infusion of 75 mg/m\^2 cisplatin q3w on Day 1 q3w, during induction dosing period of 4 or 6 cycles (Cycle length=21 days). Sintilimab 200mg intravenously administered on day 1 q3w per investigator's decision. Participants who experienced clinical benefit during the induction phase began maintenance therapy. Participants will receive oral PLB1004 and 500 mg/m\^2 of pemetrexed on Day 1 q3w and Sintilimab 200mg intravenously administered on day 1 q3w per investigator's decision. until disease progression in the maintenance period.

Trial Locations (1)

510080

Guangdong Provincial People's Hospital, Guangzhou

All Listed Sponsors
lead

Avistone Biotechnology Co., Ltd.

INDUSTRY