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

NCT06780839 | Not Yet Recruiting Phase 2

• 1 other identifier: BD-EN-IV025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NSCLC; ALK positive; MRD; adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• DFS

  From enrollment to until the date of first documented progression or date of death from any cause, whichever came first

  From enrollment to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary Outcomes (1)

• Adverse events

  From enrollment to until the date up to 60 months

Study Arms (1)

ensartinib

EXPERIMENTAL

Drug: Ensartinib

Interventions

Ensartinib DRUG

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.

ensartinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed primary non-small cell lung cancer;
• Age ≥18 years old, gender unlimited;
• The stage of the disease was based on AJCC/UICC 8th edition of lung cancer staging criteria; Complete surgical resection (R0) of primary lung cancer with Stage IA3 with high-risk recurrence factors, stage IB, II, IIIA, and IIIB (T3N2M0 only) of non-small cell lung were pathological confirmed;
• Full recovery from surgery;
• The biopsy or postoperative tumor tissue samples tested by the local laboratory are positive for ALK, and can be accepted by IHC, RT-PCR, FISH and NGS test results;
• Intended to receive enshatinib postoperative adjuvant therapy;
• ECOG physical status score is 0-1;
• Has good hematopoietic and organ function, and the laboratory test values;
• Participants with active hepatitis B or hepatitis C are allowed to be enrolled, provided that they receive strict antiviral therapy prior to medication and that liver function is adequate;
• Syphilitic positive subjects are allowed to be enrolled, but strictly standardized anti-syphilis therapy is required before medication and syphilitic heart disease and other serious complications are excluded;
• Fertile female subjects must have a negative serum pregnancy test at the time of screening and during at the end of the study; Male subjects whose partners are women of reproductive age should be surgically sterilized, or effective methods of contraception should be given during and at the end of the study;
• Sign informed consent, voluntarily and be able to comply with the procedures of the trial and follow-up.

You may not qualify if:

• Participating in a clinical study and receiving investigational drug therapy or investigational device within 4 weeks prior to initial dosing; If involved in non-interventional clinical trials can be included in this study;
• There is unresectable or metastatic disease, pathology report showing microscopic positive surgical margin or extranodal invasion.
• History of other malignancies within 5 years prior to the first dose of the study drug, except for malignancies that are expected to be cured after treatment (including but not limited to fully treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery);
• Previous treatment for NSCLC, including chemotherapy (preoperative chemotherapy treatment ≤ 2 cycles is allowed), targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, ALK, VEGFR and other pathways, monoclonal antibodies, etc.), immunotherapy, investigational therapy, etc.;
• The subject has undergone major surgery within 3 weeks prior to the first dose of the study drug (including primary tumor surgery, thoracotomy, laparotomy, excluding vascular access establishment procedures);
• Use of traditional Chinese medicine and Chinese medicine preparations with anti-tumor treatment indications or auxiliary therapeutic effects on tumors within 14 days prior to the first dose of the study drug;
• Received strong CYP3A inhibitors or inducers and narrow therapeutic index CYP3A substrates within 14 days before the first dose of the study drug;
• Clinically significant cardiovascular diseases；
• Severe active infection, interstitial lung disease / pneumonia, or any other serious underlying disease that may affect the subject's acceptance of protocol treatment within 2 weeks before the first dose;
• Positive HIV antibody test result;
• Active pulmonary tuberculosis;
• Pregnant or lactating women;
• Any other clinically significant disease or condition that the investigator believes may affect protocol compliance or the subject's signing of the informed consent form, or is not suitable for participating in this clinical trial.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Betta Pharmaceuticals Co., Ltd.: collaborator

Study Sites (1)

Beijing cancer hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ensartinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Nan Wu

CONTACT

+86-010-88196391; nanwu@bjmu.edu.cn

Shi Yan

CONTACT

dryanshi@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 17, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): January 15, 2030
• Last Updated: January 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)