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

Primary Purpose

NSCLC

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HLX208
Sponsored by
Shanghai Henlius Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai chest hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HLX208

Arm Description

Outcomes

Primary Outcome Measures

ORR
The number of patients with CR or PR divided by the total number of treated

Secondary Outcome Measures

PFS
Progression-free survival
DOR
Duration of response
OS
Overall survival

Full Information

First Posted
September 9, 2021
Last Updated
January 5, 2022
Sponsor
Shanghai Henlius Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT05065398
Brief Title
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HLX208
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
HLX208
Intervention Description
450mg bid, take orally
Primary Outcome Measure Information:
Title
ORR
Description
The number of patients with CR or PR divided by the total number of treated
Time Frame
from first dose to the last patient was followed up for 6 month
Secondary Outcome Measure Information:
Title
PFS
Description
Progression-free survival
Time Frame
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
Title
DOR
Description
Duration of response
Time Frame
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
Title
OS
Description
Overall survival
Time Frame
from the first dose to the time of death due to any cause, an average of about 2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baohui Han
Phone
86-021-22200000
Email
hanxkyy@aliyun.com
Facility Information:
Facility Name
Shanghai chest hospital
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baohui Han
Email
hanxkyy@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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