NCT06780839

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

Postoperative Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD: a Single-arm, Multicenter Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To explore the efficacy and safety of ensartinib on adjuvant therapy guided by MRD in IA3-IIIB (T3N2) stage ALK-positive non-small cell lung cancer patients.

Detailed description

Eligible subjects will take ensartinib 225 mg once daily. Postoperative tissues will be collected for customized minimal residual disease (MRD) detection (tumor-informed MRD). MRD tests will be conducted within 14 to 50 days after surgery (before adjuvant therapy), every 12 weeks ± 7 days for the first two years, and every 24 weeks ± 7 days for the third year. Subjects with negative MRD after surgery will receive ensartinib treatment. If MRD turns positive, they will receive ensartinib 225 mg QD combined with platinum-based doublet chemotherapy (2 to 4 cycles) as a step-up treatment. Subjects with positive MRD after surgery will also receive ensartinib treatment. If MRD remains positive at the next MRD test, they will receive ensartinib 225 mg QD combined with platinum-based doublet chemotherapy (2 to 4 cycles) as a step-up treatment. If MRD turns negative during treatment, ensartinib monotherapy will be resumed. If MRD turns positive again, the subsequent treatment mode will be determined by the MDT discussion group composed of the main center researchers, including but not limited to monotherapy or combination with platinum-free chemotherapy until 3 years, or MRD turns negative, or intolerable toxicity, or radiological recurrence, whichever occurs first. For patients who remain MRD positive after 3 years of treatment, the MDT group will discuss the next steps.

Conditions

• NSCLC, Stage I, II, IIIA, IIIB

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-15
• Primary completion: 2029-01-15
• Completion: 2030-01-15
• First posted: 2025-01-17
• Last updated: 2025-01-17

Locations

1 site across 1 country: China