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

NCT06780839 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-01-17

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    collaborator INDUSTRY

  • Peking University Cancer Hospital & Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2029-01-15
Completion
2030-01-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06780839 on ClinicalTrials.gov