Actively Recruiting
A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-04-08
200
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FH-006 in combination with other anti-tumor treatments in lung cancer subjects, and determine the recommended dose (RP2D) and initial efficacy for phase II clinical trials.
CONDITIONS
Official Title
A Phase II Clinical Study of FH-006 for Injection Combined With Other Anticancer Therapies in Subjects With Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Diagnosed with locally advanced or metastatic non-small cell lung cancer unsuitable for surgery or radiotherapy
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
- Adequate organ function
- Provided voluntary informed consent
- Left ventricular ejection fraction (LVEF) of 50% or higher
You will not qualify if you...
- History of other malignant tumors within the past 5 years
- Active central nervous system tumor metastasis, history of meningeal metastasis, or current meningeal metastasis
- Uncontrolled tumor-related pain
- Serious cardiovascular or cerebrovascular diseases
- Significant bleeding within 3 months before starting study medication
- Uncontrolled third-space fluid accumulation within 2 weeks before starting medication
- History of clinically significant pulmonary diseases
- Received other anti-tumor treatments within 4 weeks before study medication
- Severe infection within 4 weeks before starting medication
- Active or suspected autoimmune diseases or history of autoimmune diseases
- History of immunodeficiency
- Active pulmonary tuberculosis infection within the past year
- Chest radiation therapy over 30 Gy within 24 weeks before starting investigational drug
- Previous anti-tumor treatment adverse reactions not recovered to grade I or less
- Surgery on important organs within 4 weeks before starting medication
- Use of attenuated live vaccine within 28 days before starting investigational drug
- Serious physical or mental illness or lab abnormalities
- Pregnant or lactating women, or planning pregnancy within 14 months after last drug use
- Bleeding tendency, coagulation dysfunction, or thrombophilia
- History of hypertensive crisis or encephalopathy
- Significant vascular disease within 6 months before starting medication
- Biopsy or minor surgery within 7 days before starting medication
- Severe, unhealed wounds, active ulcers, or untreated fractures
- Gastrointestinal perforation within 6 months before starting medication
- Proteinuria of 1g or more within 7 days before medication
- Tumor surrounding or invading large blood vessels as shown by CT/MRI
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
X
Xiaouxe Pi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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