Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Pemetrexed

Cisplatin

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.

Ensatinib

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.

chemotherapy

You Lu, MD

Yang Yu, MM

Meijuan Huang, MD

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

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.

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

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

Betta Pharmaceuticals Co., Ltd.

Sichuan University

Chair of Department of Thoracic Oncology

Ensatinib 225mg QD Until the disease progresses or intolerance

Prospective, exploratory, single-arm, multi-center, real-world research

Jun Zhao, PhD

Xue Yang Yang

Jie Li, PhD

The experimental design is exploratory, single-arm, multi-center, real-world research.

Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world, Ensatinib is effective for the newly treated ALK+ advanced NSCLC

1. Efficacy and safety;
2. The relationship between molecular mechanism and curative effect;
3. Ensatinib resistance mechanism;

Enrolled patients:

1. stage IIIB or stage IV NSCLC
2. Each center confirmed ALK+ by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
3. Without any ALK-TKI treatment; Study endpoint

Primary endpoint:

According to the RECIST1.1 standard, the progression-free survival (PFS) assessed by the investigator;

Secondary endpoint:

According to the RECIST1.1 standard, the objective response rate (ORR) evaluated by the investigator; the time to treatment failure (TTF); according to the RECIST1.1 standard, the ORR and PFS of patients with different ALK fusion subtypes evaluated by the investigator; total Lifetime (OS); safety;

Exploratory endpoint:

The correlation between the biomarkers in blood or/and tissue samples and the efficacy of Ensatinib; the resistance mechanism of Ensatinib;

The sample size is determined:

The plan is to analyze 60-80 patients with EML4-ALK fusion v1 and v3 subtypes. Based on the proportion of patients with both subtypes in ALK-positive patients, the proportion is about 40%. Based on the 20% dropout rate, the plan is to include ALK without distinction. 180 patients with fusion subtype; statistical methods:

1. The patient's tumor tissue sample before taking Ensatinib
2. The patient's baseline blood sample within the first week before taking Ensantinib
3. Blood samples of patients 4-6 weeks after taking Ensatinib
4. Blood samples within 4 weeks after the patient's disease progression

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer	NCT05186506	ALK Fusion Prot... Adjuvant Therap... Non-Small Cell ...	Ensatinib chemotherapy	18 Years - 73 Years	Sichuan University
Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer	NCT05132218	ALK Positive NSCLC Stage III... NSCLC Stage IV	Ensatinib	18 Years -	Peking University Cancer Hospital & Institute
A Study Comparing Ensatinib Versus Platinum-Based Chemotherapy as Adjuvant Treatment for Stage II-IIIA ALK -Positive Non-Small Cell Lung Cancer	NCT05186506	ALK Fusion Prot... Adjuvant Therap... Non-Small Cell ...	Ensatinib chemotherapy	18 Years - 73 Years	Sichuan University

Spots Global Cancer Trial Database for ensatinib

Every month we try and update this database with for ensatinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ensatinib

Every month we try and update this database with for ensatinib cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ensatinib cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.