Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer

NCT05341583 | Recruiting Phase 3 DMC

• 1 other identifier: BTP-42338
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell lung cancer after surgical resection with or without chemotherapy.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease free survival (DFS)

  From date of randomization until date of tumor recurrence or death, whichever occurs earlier

  up to 5 years

Secondary Outcomes (4)

• DFS rate at 3 years

  Assessed at 3 years

• DFS rate at 5 years

  Assessed at 5 years

• Overall survival (OS)

  Assessed at 5 years

• OS rate at 5 years

  up to 5 years

Study Arms (2)

Ensatinib

EXPERIMENTAL

Ensatinib ( 225 mg, once daily), in accordance with the randomization schedule

Drug: Ensartinib

Placebo

PLACEBO COMPARATOR

Placebo ( 225 mg, once daily), in accordance with the randomization schedule

Drug: Placebo

Interventions

Ensartinib DRUG

Ensartinib 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier.

Also known as: X-396

Ensatinib

Placebo DRUG

Placebo 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier.

Placebo

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung.
• Patients must be classified post-operatively as Stage IB-IIIB(T3N2M0) on the basis of pathologic criteria after complete surgical resection(R0).
• Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
• Confirmation by the central laboratory that the tumour harbours ALK positive.
• At least 1-year life expectancy.
• Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
• The laboratory test values should meet the following requirements:
• Absolute neutrophil count ≥ 1.5 x 109/L , Platelets ≥ 100 x 109/L ，hemoglobin ≥9g/dL
• Total bilirubin≤ 1.5 x institutional upper limit of normal,AST and ALT≤ 2.5 x institutional upper limit of normal
• Creatinine≤ 1.5 x institutional upper limit of normal ,if not, Creatinine Clearance ≥ 50 ml/min
• International normalized ratio (INR) and prothrombin time ≤1.5 x institutional upper limit of normal; and activated partial thromboplastin time (aPTT) ≤1.5 x institutional upper limit of normal
• Female patients must have a negative pregnancy test at baseline.

You may not qualify if:

• Patients who are participating in other clinical studies or are receiving other investigational drugs , or investigational devices within 4 weeks before the first dose of our study drugs. If patients are participating in non-interventional clinical trials, they can be included in this study.
• Patients who have a presence of unresectable or metastatic disease, the pathological diagnosis show the microscopically positive surgical margins or extranodal invasion, or residual disease of surgery，or had only segmentectomies or wedge resections.
• Patients with superior sulcus cancer.
• Patients who have received a surgery with total right lung resection.
• History of other malignancies within 5 years of the first dose of the study drug, except: malignant tumors that can be expected to recover after treatment.
• Prior treatment with other anti-cancer treatments or NSCLC including chemotherapy, radiotherapy, targeted therapy (such as small molecule tyrosine kinase inhibitors targeting EGFR, VEGFR or other pathways, monoclonal antibodies, etc.), immunotherapy, investigational therapy, etc. but except platinum based chemotherapy for adjuvant therapy.
• Major surgery within 3 weeks of the first dose of the study drug.
• Patients who have used traditional Chinese medicines and traditional Chinese medicine preparations with indications for anti-tumor therapy or adjuvant therapy for tumors within 14 days of the first dose of the study drug.
• Patients who have used the following drugs within 14 days before the first dose : strong inhibitors, strong inducers of CYP3A or CYP3A substrates with a narrow therapeutic index.
• Patients who have severe cardiovascular disease.
• Patients with a known allergy to Tartrazine，a dye used in 100mg capsules.
• Severe active infection, interstitial lung disease/pneumonitis, or any serious underlying disease that may interfere with the subject's treatment with the regimen within 2 weeks prior to the first dose of study drug.
• Active HIV virus antibody,Treponema pallidum antibody positive.
• Active hepatitis B, hepatitis C virus antibody positive, or active tuberculosis.
• Presence of active gastrointestinal (GI) disease or other conditions that will interfere significantly with the absorption, distribution, metabolism, or excretion of study drugs.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

TianJin Medical University Cancer Institute & Hospital

Tianjin, China

RECRUITING

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

Chang Li Wang, Ph.D

CONTACT

86-22-23340123; wangchangli@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: May 24, 2022
• Primary Completion: June 1, 2025
• Study Completion: July 23, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)