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

NCT05065398 | Unknown Phase 2

• 1 other identifier: HLX208-NSCLC201
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• OS

  from the first dose to the time of death due to any cause, an average of about 2 year

Study Arms (1)

HLX208

EXPERIMENTAL

Drug: HLX208

Interventions

HLX208 DRUG

450mg bid, take orally

HLX208

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Shanghai chest hospital

Shanghai, 200030, China

RECRUITING

Central Study Contacts

Baohui Han

CONTACT

86-021-22200000; hanxkyy@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 4, 2021
• Study Start: November 15, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 21, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)