Evaluating Ensartinib for Advanced ALK-positive Lung Cancer
A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
This study is testing if a daily pill called Ensartinib can help people with advanced ALK-positive lung cancer feel better and live longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 490 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | Ensartinib |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05498064 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of Ensartinib in patients with advanced ALK-positive non-small cell lung cancer (NSCLC). Participants will take Ensartinib orally once daily, and treatment will continue until disease progression or other specified discontinuation criteria are met. Blood samples will be collected at three time points to analyze ctDNA and evaluate the pharmacokinetics of Ensartinib. The study will also monitor participants' survival following disease progression.
Who should consider this trial
Good fit: Ideal candidates include individuals with stage III b or IV ALK-positive NSCLC who have progressed on prior ALK-TKI treatments.
Not a fit: Patients with early-stage NSCLC or those who have not received prior ALK-TKI treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced ALK-positive NSCLC.
How similar studies have performed: Other studies have shown promising results with similar targeted therapies in ALK-positive lung cancer, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed stage III b or IV NSCLC, according to the International Association for the Study of Lung Cancer staging manual in Thoracic Oncology, 8th edition. 2. Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS; 3. Patients must have demonstrated progression during or after ALK-TKI treatment; 4. Eastern cooperative oncology group performance status (ECOG PS) of 0-2, overall survival\>3 months; 5. Patients need radiotherapy or can receive radiotherapy, such as bone metastatic lesions, intrapulmonary lesions, adrenal lesions, etc. 6. Initially general blood tests including complete blood count, biochemistry, electrolytes, and urine biochemistry were performed as a routine screening in order to identify any abnormalities. 7. Male and female patients must agree to abstain or to use two highly effective forms of contraception during the treatment period and for 90 days after the last dose of study medication. Exclusion Criteria: \-
Where this trial is running
Beijing, Beijing Municipality
- Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.