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

Primary Purpose

ALK Fusion Protein Expression, Adjuvant Therapy, Non-Small Cell Lung Cancer

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Ensatinib

chemotherapy

About this trial

This is an interventional treatment trial for ALK Fusion Protein Expression

Eligibility Criteria

18 Years - 73 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ensatinib

Platinum-Based Chemotherapy

Arm Description

225 mg administered once daily orally for two years.

Patients in the chemotherapy group were allowed to cross into the Ensatinib treatment group after the disease progressed.

Outcomes

Primary Outcome Measures

Disease free survival (DFS)

Secondary Outcome Measures

DFS at 2 years

DFS at 3 years

Overall survival (OS)

OS rate at 5 years

Full Information

NCT ID

NCT05186506

First Posted

December 29, 2021

Last Updated

January 10, 2022

Sponsor

Sichuan University

Collaborators

Betta Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05186506

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2022 (Anticipated)

Primary Completion Date

December 15, 2025 (Anticipated)

Study Completion Date

December 20, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sichuan University

Collaborators

Betta Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ALK Fusion Protein Expression, Adjuvant Therapy, Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ensatinib

Arm Type

Experimental

Arm Description

225 mg administered once daily orally for two years.

Arm Title

Platinum-Based Chemotherapy

Arm Type

Active Comparator

Arm Description

Patients in the chemotherapy group were allowed to cross into the Ensatinib treatment group after the disease progressed.

Intervention Type

Drug

Intervention Name(s)

Ensatinib

Other Intervention Name(s)

X-396

Intervention Description

225 mg administered once daily orally for two years.

Intervention Type

Drug

Intervention Name(s)

chemotherapy

Intervention Description

Pemetrexed : Participants will receive 500 mg/m^2, day 1 , Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. Cisplatin :Participants will receive 75 mg/m^2, day 1 , 21 days/cycle, Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. Paclitaxel: Participants will receive 175 mg/ m^2, day 1 , 21 days/cycle, Q21D , until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first. carboplatin AUC= 5 mg/ mL/min, intravenously guttae, day 1 ,Q21D ，until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.

Primary Outcome Measure Information:

Title

Disease free survival (DFS)

Time Frame

From date of randomization until date of the first observation of tumor recurrence, metastasis (based on imaging ) or death, up to approximately 5 years.

Secondary Outcome Measure Information:

Title

DFS at 2 years

Time Frame

Assessed at 2 years

Title

DFS at 3 years

Time Frame

Assessed at 3 years

Title

Overall survival (OS)

Time Frame

The time from the date of randomization to death from any cause, up to approximately 7 years

Title

OS rate at 5 years

Time Frame

Assessed at 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

73 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

You Lu, MD

Phone

+8618980601763

radyoulu@hotmali.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yang Yu, MM

Phone

+8618030478269

18030478269@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

You Lu, MD

Organizational Affiliation

Sichuan University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Meijuan Huang, MD

Organizational Affiliation

Sichuan University

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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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