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

Phase 2

• Conditions: NSCLC
• Interventions: Drug: HLX208

• 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

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-10-04
• Study Start: 2021-11-15
• Status Verified: 2021-12
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-21
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-30

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

Trial Locations

Locations (1)

Shanghai chest hospital; 🇨🇳 Shanghai, China