Actively Recruiting
Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer
Led by Betta Pharmaceuticals Co., Ltd. · Updated on 2024-08-23
202
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung.
- Classified post-operatively as Stage IB-IIIB (T3N2M0) based on pathology after complete surgical resection (R0).
- Fully recovered from surgery and any standard post-operative therapy at the time of randomization.
- Tumor confirmed ALK positive by central laboratory.
- Life expectancy of at least 1 year.
- Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
- Laboratory tests meeting specific blood count and organ function levels, including neutrophils, platelets, hemoglobin, bilirubin, liver enzymes, creatinine or creatinine clearance, and clotting times.
- Female patients must have a negative pregnancy test at baseline.
You will not qualify if you...
- Participation in other clinical studies or use of investigational drugs/devices within 4 weeks before starting study drug, except non-interventional trials.
- Presence of unresectable or metastatic disease, positive surgical margins, extranodal invasion, residual disease, or only segmentectomies/wedge resections.
- Diagnosis of superior sulcus cancer.
- Previous total right lung resection surgery.
- History of other malignancies within 5 years except those expected to be cured.
- Prior anti-cancer treatments for NSCLC other than platinum-based chemotherapy.
- Major surgery within 3 weeks before starting study drug.
- Use of traditional Chinese medicines for tumor therapy within 14 days before study drug.
- Use of strong CYP3A inhibitors, inducers, or narrow therapeutic index substrates within 14 days before study drug.
- Severe cardiovascular disease.
- Known allergy to Tartrazine dye.
- Severe infection, interstitial lung disease/pneumonitis, or serious underlying disease within 2 weeks before study drug.
- Active HIV, syphilis, hepatitis B or C, or tuberculosis infection.
- Active gastrointestinal disease or conditions affecting drug absorption/metabolism.
- Other conditions that may affect protocol compliance or informed consent as judged by investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
TianJin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
Research Team
C
Chang Li Wang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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