Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

January 15, 2025

Primary Completion Date

January 15, 2029

Study Completion Date

January 15, 2030

Conditions
NSCLC, Stage I, II, IIIA, IIIB
Interventions
DRUG

Ensartinib

Patients will receive Ensartinib 225mg QD by MRD test guided, if MRD test shows negative, only ensartinib will be given. if MRD test turns from negative to posive, patients will receive step-up treatment, which is ensartibe plus platinum - based doublet chemotherapy no more than 4 cycles. If MRD test turns from posive to negative, only ensartinib will be given. if MRD test constantly shows positive, MDT will determine the next step ensartib-based therapy.

Trial Locations (1)

100000

Beijing cancer hospital, Beijing

Sponsors
All Listed Sponsors
collaborator

Betta Pharmaceuticals Co., Ltd.

INDUSTRY

lead

Peking University Cancer Hospital & Institute

OTHER

NCT06780839 - Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD | Biotech Hunter | Biotech Hunter