NCT05498064Recruiting
A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov · Last updated 11 Aug 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 490 (estimated)
- First submitted
- 17 May 2022
- Start date
- 13 May 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Lung cancer
- NCT number
- NCT05498064
What you commit to
- Study type: Observational
- Planned participants: 490
- From 13 May 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \-
Who the study is looking for
- 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.
- Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS;
- Patients must have demonstrated progression during or after ALK-TKI treatment;
- Eastern cooperative oncology group performance status (ECOG PS) of 0-2, overall survival\>3 months;
- Patients need radiotherapy or can receive radiotherapy, such as bone metastatic lesions, intrapulmonary lesions, adrenal lesions, etc.
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.