A Phase II Clinical Trial to Evaluate HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation
Study Details
Study Description
Brief Summary
Evaluate the efficacy，safety and pharmacokinetics of HLX208 in advanced non-small cell lung cancer patients with BRAF V600 mutation
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HLX208
|
Drug: HLX208
450mg bid, take orally
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai chest hospital | Shanghai | China | 200030 |
Sponsors and Collaborators
- Shanghai Henlius Biotech
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HLX208-NSCLC201