Actively Recruiting
Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW
Led by Hunan Province Tumor Hospital · Updated on 2024-09-20
100
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase II, open-label, single-arm, single-center clinical study to evaluate the preliminary efficacy of sunvozertinib in combination with anlotinib in patients with EGFR-sensitive mutations and co-mutations in locally advanced or metastatic treatment-naive non-small cell lung cancer.
CONDITIONS
Official Title
Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR Mutant Advanced NSCLC-RW
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed informed consent.
- Age 18 years or older.
- Confirmed locally advanced or metastatic non-small cell lung cancer without prior systemic treatment.
- EGFR-sensitive mutations (exon 19 deletions, exon 21 L858R, T790M) combined with co-mutations.
- ECOG performance status 0 to 1.
- Predicted survival of at least 12 weeks.
- Adequate bone marrow and organ function.
- Presence of measurable lesions according to RECIST 1.1.
- Stable brain metastases allowed.
You will not qualify if you...
- Previous systemic therapy for locally advanced or metastatic disease.
- Treatment with EGFR or VEGFR antibodies within 4 weeks before first dose.
- Radiation therapy within 14 days before first dose or unresolved radiation toxicity.
- Ongoing or recent use of strong CYP1A2 or CYP3A inhibitors or inducers.
- Presence of spinal cord compression or meningeal metastasis.
- History of other cancers within 2 years.
- Severe adverse events (except alopecia) from prior treatments above grade 1.
- Stroke or brain hemorrhage within 6 months before first dose.
- Severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding.
- Active infections such as hepatitis B, hepatitis C, HIV, or COVID-19.
- Heart disease or abnormalities.
- History of interstitial lung disease or immune-related pneumonia.
- Severe nausea, vomiting, or gastrointestinal conditions preventing drug absorption.
- Live vaccine given within 2 weeks before first medication.
- Pregnancy or breastfeeding.
- Allergy to study drugs or ingredients.
- Other conditions judged 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
CONTACT
L
Liang Zeng
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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