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

Launched by BETTA PHARMACEUTICALS CO., LTD. · Apr 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ensartinib to see if it can help prevent the return of non-small cell lung cancer in patients who have already had surgery to remove their tumors. The trial is specifically for patients whose tumors are positive for a gene alteration called ALK, and who have been classified as having stage II to IIIB disease after surgery. Participants will be randomly assigned to receive either ensartinib or a placebo (a non-active treatment that looks like the real drug) for a certain period of time.

To be eligible for this trial, patients must have had surgery to remove their lung cancer and have fully recovered from it. They also need to have a confirmed ALK-positive tumor and a good overall health status, meaning they should be able to perform daily activities without major issues. Participants can expect regular check-ups and monitoring throughout the trial to assess their health and the effects of the treatment. It’s important to note that patients currently involved in other clinical trials or with certain health conditions may not be able to join. This trial aims to gather important information about the effectiveness and safety of ensartinib as an additional treatment option for non-small cell lung cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • 1. Absolute neutrophil count ≥ 1.5 x 109/L , Platelets ≥ 100 x 109/L ，hemoglobin ≥9g/dL
• • 2. Total bilirubin≤ 1.5 x institutional upper limit of normal,AST and ALT≤ 2.5 x institutional upper limit of normal
• • 3. Creatinine≤ 1.5 x institutional upper limit of normal ,if not, Creatinine Clearance ≥ 50 ml/min
• • 4. 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.
• Exclusion Criteria:
• • 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.
• • According to the judgment of the investigator, other conditions may affect the compliance of the protocol or affect the subject's signing of the informed consent, or is not suitable for participating in this clinical trial.