Actively Recruiting
Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC
Led by Hunan Province Tumor Hospital · Updated on 2024-09-19
52
Participants Needed
1
Research Sites
147 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. Condition or disease Intervention/treatment Phase Non-Small Cell Lung Cancer Drug: sunvozertinib Drug: anlotinib Phase 2
CONDITIONS
Official Title
Sunvozertinib Plus Anlotinib as 1L Treatment in EGFR-Sensitive Mutations Combined With Co-Mutations Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and agree to the clinical trial by signing informed consent.
- Age 18 years or older.
- Confirmed locally advanced or metastatic non-small cell lung cancer without prior systemic treatment.
- Presence of EGFR-sensitive mutations (exon 19 deletions, exon 21 L858R, T790M) combined with co-mutations.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Predicted survival of at least 12 weeks.
- Adequate bone marrow and organ function.
- Measurable cancer lesions according to RECIST 1.1 criteria.
- Stable brain metastases allowed.
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 starting the study drug.
- Radiation therapy within 14 days before the first dose or unresolved radiation-related toxicity.
- Ongoing or recent use of strong CYP1A2 or CYP3A inhibitors or inducers within 1-2 weeks before treatment.
- Presence of spinal cord compression or meningeal metastasis.
- History of other cancers within the past 2 years.
- Severe side effects (above grade 1) from prior treatments.
- Stroke or brain bleeding within 6 months before starting treatment.
- Severe or uncontrolled systemic diseases including hypertension or active bleeding.
- Persistent or active infections such as hepatitis B, hepatitis C, HIV, or COVID-19.
- Heart diseases or abnormalities.
- Past or current interstitial lung disease or immune-related lung inflammation.
- Severe nausea, vomiting, gastrointestinal diseases, or inability to absorb study drugs.
- Live vaccine within 2 weeks before treatment.
- Women who are pregnant or breastfeeding.
- Allergy to study drugs or ingredients.
- Other conditions making participation unsuitable as judged by the investigator.
AI-Screening
AI-Powered Screening
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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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