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

NCT05186506 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: BD-EN-IV005
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Disease free survival (DFS)

  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 Outcomes (4)

• DFS at 2 years

  Assessed at 2 years

• DFS at 3 years

  Assessed at 3 years

• Overall survival (OS)

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

• OS rate at 5 years

  Assessed at 5 years

Study Arms (2)

Ensatinib

EXPERIMENTAL

225 mg administered once daily orally for two years.

Drug: Ensatinib

Platinum-Based Chemotherapy

ACTIVE COMPARATOR

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

Drug: chemotherapy

Interventions

Ensatinib DRUG

225 mg administered once daily orally for two years.

Also known as: X-396

Ensatinib

chemotherapy DRUG

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.

Platinum-Based Chemotherapy

Eligibility Criteria

• Age: 18 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan University: lead
• Betta Pharmaceuticals Co., Ltd.: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

ensartinib; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• You Lu, MD

  Sichuan University

  STUDY CHAIR

• Meijuan Huang, MD

  Sichuan University

  STUDY CHAIR

Central Study Contacts

You Lu, MD

CONTACT

+8618980601763; radyoulu@hotmali.com

Yang Yu, MM

CONTACT

+8618030478269; 18030478269@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Thoracic Oncology

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 11, 2022
• Study Start: January 1, 2022
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 20, 2028
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share