Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer

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Brief Title

Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer

Official Title

Adjuvant Therapy of Ensatinib in Patients With Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer: a Prospective, Multi-center, Single-arm Exploratory Study

Brief Summary

      This is a prospective, multi-center, single-arm, phase 2 study aiming to assess the efficacy
      and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer (NSCLC)
      with positive ALK-fusion. Enrolled patients will take Ensatinib for 3 years or until
      recurrence of the disease or intolerable toxicity, following complete tumour resection with
      or without adjuvant standard chemotherapy.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

3-year disease free survival rate (DFSR)

Secondary Outcome

 5-year overall survival rate

Condition

Non-small Cell Lung Cancer

Intervention

Ensartinib

Study Arms / Comparison Groups

 Ensartinib
Description:  Ensartinib 225mg oral daily for 3 years or until recurrence of the disease or intolerable toxicity

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

80

Start Date

February 2022

Completion Date

February 2029

Primary Completion Date

February 2027

Eligibility Criteria

        Inclusion Criteria:

          -  Completely resected pathological stage IB-IIIA NSCLC with ALK-fusion positive
             (confirmed by FISH, IHC or NGS).

          -  Males or females aged ≥18 years, ≤75 years.

          -  ECOG performance status 0-2.

          -  Completely recovered from surgery or standard postoperative chemotherapy before
             receiving adjuvant ensatinib treatment. (When starting the study treatment, the
             patient must have recovered from all toxicities greater than CTCAE Grade 1 caused by
             the previous treatment, except for hair loss and Grade 2 neuropathy related to
             previous platinum-based treatments).

          -  Clinical examinations before treatment report no signs of disease recurrance.

          -  With enough tumor histology specimens (non-cytology) for molecular marker analysis.

          -  hemoglobin concentration ≥ 100 g/L (permit to maintain hematologic criteria by blood
             transfusion); absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count ≥100×10^9/L.

          -  Liver Function: TBil ≤2xULN; ALT and AST ≤2.5xULN;

          -  Renal Function: Cr ≤1.5xULN, and Ccr ≥60ml/min;

          -  Signed inform consent form by patient or his/her legal representative.

          -  Comply with study protocol and procedure, and be able to take oral medication.

          -  Female patients of childbearing potential must have a negative urine pregnancy test
             within 7 days before study treatment.

          -  Eligible patients of reproductive potential (both sexes) must agree to use a reliable
             method of birth control before enrollment, during the study period and for at least 8
             weeks after their last dose of study therapy.

        Exclusion Criteria:

          -  Having targeted medication therapy (including tyrosine kinase inhibitor or monoclonal
             antibody) and experimental therapy for NSCLC in the past.

          -  Having local radiotherapy of NSCLC.

          -  Known allergy to Ensatinib or any of the ingredients in this product.

          -  Previously suffering from interstitial lung disease, drug-induced interstitial
             disease, radiation pneumonia that requires hormone therapy, or any clinically
             evidenced active interstitial lung disease; CT scan at baseline revealed the presence
             of idiopathic pulmonary fibrosis.

          -  Any unstable systemic disease, including: active infection, uncontrolled high blood
             pressure, unstable angina pectoris, angina pectoris that started within the last 3
             months, congestive heart failure (≥ New York Heart Association [NYHA] II Grade),
             myocardial infarction (6 months before enrollment), severe arrhythmia requiring
             medical treatment; liver, kidney or metabolic diseases.

          -  Women who are pregnant or breastfeeding.

          -  Having history of neurological or psychiatric disorders, including epilepsy or
             dementia.

          -  Other conditions investigators evaluate that patient is not eligible to this study.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

, 13931152296, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05241028

Organization ID

BD-EN-IV006


Responsible Party

Principal Investigator

Study Sponsor

Hebei Medical University Fourth Hospital


Study Sponsor

, , 


Verification Date

February 2022