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

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05065398
• Other study ID #: HLX208-NSCLC201
• Status: Recruiting
• Phase: Phase 2
• Start date: November 15, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: December 2021
• Source: Shanghai Henlius Biotech
• Contact: Baohui Han
• Phone: 86-021-22200000
• Email: hanxkyy[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• HLX208
450mg bid, take orally

Locations

Country	Name	City	State
China	Shanghai chest hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	OS	Overall survival	from the first dose to the time of death due to any cause, an average of about 2 year