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New treatment option for Non-small Cell Lung Cancer
Official title Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05341583
What this study is testing
What is Ensartinib?
Ensartinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as X-396.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join if
- Patients who are participating in other clinical studies or are receiving other investigational drugs , or investigational devices within 4 weeks...
- Patients who have a presence of unresectable or metastatic disease, the pathological diagnosis show the microscopically positive surgical margins or...
- 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...
- Prior treatment with other anti-cancer treatments or NSCLC including chemotherapy, radiotherapy, targeted therapy (such as small molecule tyrosine...
See the full eligibility 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:
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.