Actively Recruiting
A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
Led by Peking Union Medical College Hospital · Updated on 2022-08-11
490
Participants Needed
1
Research Sites
342 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
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.
CONDITIONS
Official 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 confirmed by FISH, Ventana IHC, RT-PCR, or NGS
- Disease progression during or after ALK-TKI treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and overall survival greater than 3 months
- Need for radiotherapy or ability to receive radiotherapy for lesions such as bone metastases, intrapulmonary lesions, or adrenal lesions
- Routine general blood tests performed with no disqualifying abnormalities
- Agreement to use two effective contraception methods during treatment and for 90 days after last dose for both males and females
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
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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