Actively Recruiting
A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
Led by Peking Union Medical College Hospital · Updated on 2022-08-11
490
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
B
Betta Pharmaceuticals Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of Ensartinib in people with advanced ALK-positive non-small cell lung cancer (NSCLC). The study aims to evaluate how well Ensartinib works and its safety, as well as to understand how the drug moves through the body and how resistance to it may develop. This research is observational and focuses on patients whose cancer has progressed after previous ALK-TKI treatments. Participants will take Ensartinib orally at a dose of 225 mg once daily. Treatment continues until the disease worsens or if certain conditions like patient choice, side effects, or pregnancy occur. When the disease progresses, patients enter a follow-up period to monitor survival until death, withdrawal, or study end. Blood samples will be collected three times: before starting treatment, after 8 weeks, and at disease progression, to analyze genetic material and drug levels. During the study, participants will undergo routine blood tests and assessments of their cancer status. Researchers will track progression-free survival over 36 months as the main outcome. They will also measure response rates, overall survival up to 48 months, and record any adverse events. This comprehensive monitoring helps evaluate how patients respond to Ensartinib and understand the safety of treatment over time.
CONDITIONS
Brief Title
A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed stage IIIb or IV non-small cell lung cancer
- Documented ALK-positive disease by FISH, Ventana IHC, RT-PCR, or NGS
- Disease progression during or after ALK-TKI treatment
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2 and overall survival greater than 3 months
- Requires or can receive radiotherapy for lesions such as bone metastases, intrapulmonary, or adrenal lesions
- Routine blood tests including complete blood count, biochemistry, electrolytes, and urine biochemistry performed
- Agreement to use two effective forms of contraception during treatment and for 90 days after last dose for male and female patients
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or treatment discontinuation
Participants receive Ensartinib 225 mg orally once daily until disease progression or other discontinuation criteria are met.
Blood samples collected 3 times: before treatment, at 8 weeks of treatment, and at disease progression
Duration - Up to study closure or participant withdrawal
Participants enter survival follow-up until death, withdrawal of consent, or study closure.
Visit schedule not specified
Trial Site Locations
Total: 1 location
1
Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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