Actively Recruiting
An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung Cancer
Led by Henan Cancer Hospital · Updated on 2024-05-31
39
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open, multicenter exploratory clinical trial to observe and evaluate the efficacy and safety of Iruplinalkib Tablets in patients with ROS1 positive non-small cell lung cancer.
CONDITIONS
Official Title
An Exploratory Study of Efficacy and Safety of Iruplinalkib Tablets in Patients With ROS1 Positive Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers must sign informed consent
- Age 18 years or older
- Histologically or cytologically confirmed stage III unresectable or stage IV ROS1 positive non-small cell lung cancer
- ECOG performance status between 0 and 2
- At least one measurable lesion according to RECIST 1.1 criteria
- Ability to swallow pills normally
- No brain metastases, or brain metastases that are asymptomatic or stable for over 4 weeks after treatment
- Adequate vital organ function as defined by specific blood count and chemistry values
- Use of medically approved contraception during treatment and for 3 months after, with negative pregnancy tests for women of childbearing potential
- Non-lactating female participants
You will not qualify if you...
- Participation in another clinical study or use of investigational drugs or devices within 4 weeks prior to first dose (except non-interventional trials)
- Mixed small cell and non-small cell lung cancer histology
- Known interstitial lung disease or active non-infectious pneumonia
- Other malignancies within past 5 years except certain cured skin or cervical cancers
- Surgery or immunotherapy within 4 weeks, or radiotherapy within 2 weeks prior to first dose
- Uncontrolled high blood pressure or history of hypertensive crisis
- Unstable heart conditions including heart failure, angina, recent myocardial infarction, arrhythmias, or prolonged QTc interval
- Pleural, pericardial, or ascites effusions requiring drainage unless stable after treatment
- Immune deficiencies such as HIV, or active hepatitis B or C infections
- Administration of live vaccine within 4 weeks prior to or during study
- Active gastrointestinal diseases affecting drug absorption or metabolism
- Known allergy to the study drug or its components
- Other conditions judged by the investigator to affect safety or study results, including substance abuse, serious illnesses, or social factors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Henan cancer hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
Y
Yanqiu Zhao
CONTACT
J
Jie Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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