NCT05241028 Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
| NCT ID | NCT05241028 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hebei Medical University Fourth Hospital |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2022-05-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, multi-center, single-arm, phase 2 study aiming to assess the efficacy and safety of adjuvant use of Ensartinib in stage IB-IIIA non-small cell lung cancer (NSCLC) with positive ALK-fusion. Enrolled patients will take Ensatinib for 3 years or until recurrence of the disease or intolerable toxicity, following complete tumour resection with or without adjuvant standard chemotherapy.
Eligibility Criteria
Inclusion Criteria: * Completely resected pathological stage IB-IIIA NSCLC with ALK-fusion positive (confirmed by FISH, IHC or NGS). * Males or females aged ≥18 years, ≤75 years. * ECOG performance status 0-2. * Completely recovered from surgery or standard postoperative chemotherapy before receiving adjuvant ensatinib treatment. (When starting the study treatment, the patient must have recovered from all toxicities greater than CTCAE Grade 1 caused by the previous treatment, except for hair loss and Grade 2 neuropathy related to previous platinum-based treatments). * Clinical examinations before treatment report no signs of disease recurrance. * With enough tumor histology specimens (non-cytology) for molecular marker analysis. * hemoglobin concentration ≥ 100 g/L (permit to maintain hematologic criteria by blood transfusion); absolute neutrophil count (ANC) ≥1.5×10\^9/L; platelet count ≥100×10\^9/L. * Liver Function: TBil ≤2xULN; ALT and AST ≤2.5xULN; * Renal Function: Cr ≤1.5xULN, and Ccr ≥60ml/min; * Signed inform consent form by patient or his/her legal representative. * Comply with study protocol and procedure, and be able to take oral medication. * Female patients of childbearing potential must have a negative urine pregnancy test within 7 days before study treatment. * Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 8 weeks after their last dose of study therapy. Exclusion Criteria: * Having targeted medication therapy (including tyrosine kinase inhibitor or monoclonal antibody) and experimental therapy for NSCLC in the past. * Having local radiotherapy of NSCLC. * Known allergy to Ensatinib or any of the ingredients in this product. * Previously suffering from interstitial lung disease, drug-induced interstitial disease, radiation pneumonia that requires hormone therapy, or any clinically evidenced active interstitial lung disease; CT scan at baseline revealed the presence of idiopathic pulmonary fibrosis. * Any unstable systemic disease, including: active infection, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that started within the last 3 months, congestive heart failure (≥ New York Heart Association \[NYHA\] II Grade), myocardial infarction (6 months before enrollment), severe arrhythmia requiring medical treatment; liver, kidney or metabolic diseases. * Women who are pregnant or breastfeeding. * Having history of neurological or psychiatric disorders, including epilepsy or dementia. * Other conditions investigators evaluate that patient is not eligible to this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05241028 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05241028 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05241028 currently recruiting?
Yes, NCT05241028 is actively recruiting participants. Contact the research team at liujf@hbmu.edu for enrollment information.
Where is the NCT05241028 trial being conducted?
This trial is being conducted at Shijiazhuang, China.
Who is sponsoring the NCT05241028 clinical trial?
NCT05241028 is sponsored by Hebei Medical University Fourth Hospital. The trial plans to enroll 80 participants.
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