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

Launched by SICHUAN UNIVERSITY · Jan 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ensatinib to see how well it works compared to standard chemotherapy treatments for patients with a specific type of lung cancer called ALK-positive non-small cell lung cancer. This study is for adults who have had surgery to remove their cancer and are in stages IIA to IIIA of the disease. Participants must have had their surgery within the last 10 weeks and have a confirmed diagnosis of ALK-positive disease. They also need to be in generally good health, with a life expectancy of at least three months.

If you or a loved one qualify for this trial, you can expect to receive either ensatinib or chemotherapy as additional treatment after surgery. The study is designed to find out which treatment is more effective and safe. Participants will be carefully monitored throughout the trial to track their health and any side effects. It’s important to note that the trial is not yet recruiting participants, so it may take some time before enrollment begins.

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ALL

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