A Phase II Clinical Trial to Evaluate HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation

Study Overview
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Brief Summary
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Evaluate the efficacy，safety and pharmacokinetics of HLX208 in advanced non-small cell lung cancer patients with BRAF V600 mutation

Official Title
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An Open Label， Multicenter Phase II Clinical Trial to Evaluate the Efficacy，Safety and Pharmacokinetics of HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation

Conditions
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NSCLC

Intervention / Treatment
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* Drug: HLX208


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLX208<br> | Drug: HLX208<br>* 450mg bid, take orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | The number of patients with CR or PR divided by the total number of treated | from first dose to the last patient was followed up for 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival | 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 | 
| DOR | Duration of response | 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 | 
| OS | Overall survival | from the first dose to the time of death due to any cause, an average of about 2 year |