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
Overview
- Phase
- Phase 2
- Intervention
- Ensatinib
- Conditions
- ALK Fusion Protein Expression
- Sponsor
- Sichuan University
- Enrollment
- 152
- Primary Endpoint
- Disease free survival (DFS)
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
You Lu
Chair of Department of Thoracic Oncology
Sichuan University
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
Arms & Interventions
Ensatinib
225 mg administered once daily orally for two years.
Intervention: Ensatinib
Platinum-Based Chemotherapy
Patients in the chemotherapy group were allowed to cross into the Ensatinib treatment group after the disease progressed.
Intervention: chemotherapy
Outcomes
Primary Outcomes
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 Outcomes
- DFS at 2 years(Assessed at 2 years)
- DFS at 3 years(Assessed at 3 years)
- OS rate at 5 years(Assessed at 5 years)
- Overall survival (OS)(The time from the date of randomization to death from any cause, up to approximately 7 years)