To Evaluate the Efficacy of QLH11811 in Advanced NSCLC Patients With EGFR Mutation

PHASE1RecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

October 25, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Non-small Cell Lung Cancer
Interventions
DRUG

QLH11811

"In Ia phase, subjects will first receive oral single dose of QLH11811, then will be observed for 7 days. If the drug is tolerated by the subjects, the subjects will continue to receive the oral repeat dose of QLH11811 for 21 consecutive days. Upon the completion of observation for DLT in the subjects (DLT observation period is the 28 days after the first dose), the subjects will continue to receive the repeat dose of QLH11811 in Cycle 2 and subsequent cycles. The dosing frequency in Cycle 2 and subsequent cycles is once daily, and each cycle has 3 weeks.~The RP2D of QLH11811 is determined on the basis of comprehensive evaluation of all safety and tolerability data and all available PK, PD and efficacy data during the dose escalation phase. In phase 1b, the cohort expansion study is carried out for all cohorts in China and the United States concurrently according to the determined RP2D."

Trial Locations (1)

273200

RECRUITING

Qilu Pharmaceutical.Co.,Ltd, Jinan

All Listed Sponsors
lead

Qilu Pharmaceutical Co., Ltd.

INDUSTRY