Actively Recruiting
ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma
Led by Hunan Province Tumor Hospital · Updated on 2024-09-20
90
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was to explore the efficacy of ALK-TKI in lung squamous cell carcinoma. Approximately 5% of lung adenocarcinomas have oncogenic fusions of EML-4 and ALK a mutation associated with tumorigenesis and migration.
CONDITIONS
Official Title
ALK Tyrosine Kinase Inhibitors in ALK-rearranged Advanced Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed informed consent after understanding the trial requirements
- Age 18 years or older
- Confirmed advanced squamous cell carcinoma of the lung by histopathology or cytology without prior systemic treatment
- ALK fusion positive confirmed by IHC (ventana), NGS, or FISH
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Predicted survival of at least 12 weeks
- Adequate bone marrow and organ function
- Presence of measurable tumor lesions according to RECIST 1.1
- Patients with stable brain metastases may be included
You will not qualify if you...
- Prior systemic therapy for locally advanced or metastatic disease
- Treatment with EGFR or VEGFR antibodies within 4 weeks before study drug start
- Radiation therapy within 14 days before study drug start or unresolved radiation toxicity
- Use of potent CYP1A2 or CYP3A inhibitors or inducers within 1 to 2 weeks before study drug start
- Presence of spinal cord compression or meningeal metastasis
- History of other cancers within 2 years
- Severe adverse events from prior treatments above grade 1 (except alopecia)
- Stroke or brain hemorrhage within 6 months before study drug start
- Severe or uncontrolled systemic diseases, including active bleeding
- Persistent or active infections including hepatitis B, hepatitis C, HIV, or COVID-19
- Heart diseases or abnormalities
- History of interstitial lung disease or immune-related pneumonia with active symptoms
- Chronic gastrointestinal disorders affecting drug absorption
- Live vaccine administered within 2 weeks before first medication
- Pregnant or breastfeeding women
- Hypersensitivity to study drugs or ingredients
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
Research Team
Y
Yongchang Zhang, MD
CONTACT
N
Nong Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here