Stage III unresectable ALK-positive non-small cell lung cancer (NSCLC)
Conditions
Interventions
Placebo treatment group:Oral, placebo capsule once daily until progression or intolerable toxicity
upon progression, patients will crossover to ensartinib treatment until intolerance or further progression.
Ensartinib treatment group:Oral, ensartinib 225 mg once daily until progression or intolerable toxicity.
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Histologically or cytologically confirmed stage III unresectable non-small cell lung cancer (NSCLC) with potential for curative treatment; 3. Confirmed ALK fusion positivity by FISH, IHC, or NGS; 4. ECOG performance status 0-1; 5. Completed platinum-based concurrent or sequential chemoradiotherapy as per protocol requirements; 6. Chemoradiotherapy must be completed no more than 6 weeks prior to randomization; 7. No disease progression during or after chemoradiotherapy; 8. Expected survival > 12 weeks; 9. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to treatment initiation; 10. Written informed consent obtained from the patient or their legally authorized representative; 11. Male and female patients of childbearing potential must agree to use reliable contraception from study enrollment, throughout the study period, and for 8 weeks after discontinuation of treatment.
Exclusion criteria
Exclusion criteria: 1. Presence of mixed small cell and non-small cell lung cancer pathology; 2. Development of symptomatic pneumonia following chemoradiotherapy, with failure to control to = Grade 2 from prior chemoradiotherapy (according to CTCAE criteria); 4. Poor cardiac status, including but not limited to any of the following: (1) Mean resting corrected QT interval (QTc) >470 ms (derived from three ECGs); (2) Any clinically significant abnormality in resting ECG rhythm, conduction, or morphology; (3) Any factor increasing the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or concomitant use of any drug known to prolong the QT interval and cause torsades de pointes; 5. Inadequate bone marrow reserve or organ function; 6. History of other malignancies, except for adequately treated non-melanoma skin cancer or malignant lentigo, cured in situ carcinoma, or other solid tumors with no evidence of disease for >5 years post-cure and deemed by the treating physician to have no significant risk of recurrence; 7. Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding tendency; or active infections, including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV); 8. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow formulated products, or prior significant bowel resection resulting in inadequate absorption of ensartinib; 9. Prior chemotherapy, radiotherapy, immunotherapy, or investigational drug therapy outside of definitive treatment for locally advanced disease; 10. Prior treatment with an ALK-TKI; 11. Major surgery performed within 4 weeks prior to first dose of study drug; 12. Concurrent use of known strong CYP3A4 inducers (cannot be discontinued for at least 3 weeks prior to first dose of study drug); 13. Known hypersensitivity to ensartinib or any component of this product; 14. Pregnancy or lactation; 15. History of documented neurological or psychiatric disorders, including epilepsy or dementia; 16. Any other condition deemed by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Overall Survival;Central Nervous System Progression-Free Survival; | — |
Countries
China
Contacts
Public ContactXu Yaping
Shanghai Pulmonary Hospital
Outcome results
None listed