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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    20
  • sponsor
    Shanghai Henlius Biotech
Updated on 23 March 2022
BRAF
lung carcinoma

Summary

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

Details
Condition NSCLC
Treatment HLX208
Clinical Study IdentifierNCT05065398
SponsorShanghai Henlius Biotech
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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
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