A Phase II Clinical Trial to Evaluate HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation
- Registration Number
- NCT05065398
- Lead Sponsor
- Shanghai Henlius Biotech
- Brief Summary
Evaluate the efficacy,safety and pharmacokinetics of HLX208 in advanced non-small cell lung cancer patients with BRAF V600 mutation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Age>=18Y
- Good Organ Function
- Expected survival time ≥ 3 months
- advanced BRAF V600 NSCLC that have been diagnosed histologically or cytology and have failed standard treatment or unable to receive, or refusing standard care.
- Previous failure to standard treatment, or insuitability for standard treatment or refuse standard treatment.
- ECOG score 0-2;
Exclusion Criteria
- Previous treatment with BRAF inhibitors or MEK inhibitors
- Presence of EGFR mutations or ALK rearrangements (unless disease progression following prior treatment with tyrosine kinase inhibitors).
- Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 1 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- Current or former patients with interstitial lung disease;
- Severe active infections requiring systemic anti-infective therapy
- A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery.
- Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HLX208 HLX208 -
- Primary Outcome Measures
Name Time Method ORR from first dose to the last patient was followed up for 6 month The number of patients with CR or PR divided by the total number of treated
- Secondary Outcome Measures
Name Time Method PFS the time (month is regarded as the unit) from the first dose to the date of first documented progression or date of death from any cause, whichever came first,through treatment completion, an average of about 1 year Progression-free survival
DOR from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first),through treatment completion, an average of about 1 year Duration of response
OS from the first dose to the time of death due to any cause, an average of about 2 year Overall survival
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does HLX208 target in BRAF V600-mutated NSCLC?
How does HLX208 compare to other BRAF inhibitors in treating advanced NSCLC?
Are there specific biomarkers that predict HLX208 efficacy in BRAF V600-mutant NSCLC patients?
What are the potential adverse events associated with HLX208 in phase II NSCLC trials?
What combination therapies are being explored with HLX208 for BRAF V600-mutated NSCLC?
Trial Locations
- Locations (1)
Shanghai chest hospital
🇨🇳Shanghai, China
Shanghai chest hospital🇨🇳Shanghai, ChinaBaohui HanContacthanxkyy@aliyun.com