A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer

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Brief Title

A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer

Official Title

A Phase II, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer

Brief Summary

      This randomized, active-controlled, multicenter, open-label, Phase II study is designed to
      evaluate the efficacy and safety of ensatinib compared with Platinum-Based Chemotherapy as
      adjuvant treatment in ALK fusion positive II-IIIA stage non-small cell lung cancer after
      surgical resection
    

Detailed Description

      Participants in the experimental arm will receive Ensatinib at 225 mg orally once a day (QD)
      taken with food for 2 years. Participants in the control arm will receive one of the protocol
      specified platinum based chemotherapy regimens for 4 cycles. Treatments will continue until
      disease recurrence, meeting one of treatment discontinuation criteria (eg, patient decision,
      adverse event, pregnancy), or achieving a maximum treatment duration of 2 years. At the time
      of disease recurrence, participants will enter a survival follow-up until death, withdrawal
      of consent or study closure, whichever occurs earlier.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Disease free survival (DFS)

Secondary Outcome

 DFS at 2 years

Condition

ALK Fusion Protein Expression

Intervention

Ensatinib

Study Arms / Comparison Groups

 Ensatinib
Description:  225 mg administered once daily orally for two years.

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

152

Start Date

January 1, 2022

Completion Date

December 20, 2028

Primary Completion Date

December 15, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Surgical resection of histologically confirmed Stage IIA to IIIA NSCLC with negative
             margins, ,within 10 weeks after the operation

          -  Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS

          -  Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1

          -  At least 3-months life expectancy

          -  Adequate organ function

          -  Any major surgery should be completed at least 4 weeks before the first study drug
             treatment. Minor surgery/procedures must be completed at least 2 weeks before taking
             medication.

          -  Willingness and ability to comply with the trial and follow-up procedures

          -  Written informed consents are required to indicate that the patients are aware of the
             investigational nature of the study

        Exclusion Criteria:

          -  More than 10 weeks before surgery Other co-existing malignancies or malignancies
             diagnosed within the last 5 years with the exception of basal cell carcinoma or
             cervical cancer in situ

          -  Use of other investigational drug within 4 weeks prior to the first dose of Ensartinib

          -  Prior stem cell or organ transplant

          -  severe cardiovascular disease

          -  Presence of active gastrointestinal (GI) disease or other conditions that will
             interfere significantly with the absorption, distribution, metabolism, or excretion of
             Ensartinib

          -  Active hepatitis B, hepatitis C virus antibody positive, HIV virus antibody, Treponema
             pallidum antibody positive

          -  History of interstitial lung disease, drug-induced interstitial lung disease, history
             of radiation pneumonitis requiring steroid therapy, or any clinical signs of active
             interstitial lung disease

          -  Reproductive or pregnant or breastfeeding female with a positive serum pregnancy test
             7 days before starting treatment , Male or female patients failure to take effective
             contraceptive measures or plan to give birth during the entire treatment period and 3
             months after treatment ends

          -  Patients with a known allergy or delayed hypersensitivity reaction to drugs chemically
             related to ensartinib or to the active ingredient of ensartinib

          -  History of drug allergy, such as a history of allergies to pemetrexed, carboplatin or
             other platinum compounds, or their preventive medications; History of allergies to
             paclitaxel components; or uncontrolled asthma

          -  Patients who have used the following drugs within 14 days before the first dose or who
             need to use the following drugs during treatment: drugs that cause QTc prolongation
             and/or torsade de pointes-type ventricular tachycardia; strong inhibitors or strong
             inducers of CYP3A

          -  Patients being treated with warfarin or any other coumarin derivative anticoagulant

          -  According to the judgment of the investigator, other severe, acute or chronic medical
             conditions that may increase the risk associated with participating in the study, or
             may interfere with the interpretation of the study results

          -  Concurrent condition evaluated by investigator that would make it inappropriate for
             the patient to be enrolled
      

Gender

All

Ages

18 Years - 73 Years

Accepts Healthy Volunteers

No

Contacts

You Lu, MD, +8618980601763, [email protected]



Administrative Informations


NCT ID

NCT05186506

Organization ID

BD-EN-IV005


Responsible Party

Principal Investigator

Study Sponsor

Sichuan University

Collaborators

 Betta Pharmaceuticals Co., Ltd.

Study Sponsor

You Lu, MD, Study Chair, Sichuan University


Verification Date

December 2021