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

Henlius Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

NSCLC

Treatments

Drug: HLX208

Study type

Interventional

Funder types

Industry

Identifiers

HLX208-NSCLC201

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.