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Trial Title:
Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
NCT ID:
NCT06574347
Condition:
Non-Small-Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Osimertinib
Conditions: Keywords:
NSCLC
Lung Cancer
MET Amplification
EGFR L858R
EGFR Exon 19 Deletion
EGFR
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Vebreltinib
Description:
Subjects will receive Vebreltinib orally twice per day (BID).
Arm group label:
Vebreltinib 150mg BID+PLB1004 80mg QD
Other name:
Bozitinib
Other name:
PLB1001
Intervention type:
Drug
Intervention name:
Osimertinib
Description:
Subjects will receive Osimertinib 80mg orally once per day (QD).
Arm group label:
Osimertinib 80mg QD
Other name:
AZD9291
Intervention type:
Drug
Intervention name:
PLB1004
Description:
Subjects will receive PLB1004 80mg orally once per day (QD).
Arm group label:
Vebreltinib 150mg BID+PLB1004 80mg QD
Other name:
Andamertinib
Summary:
Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for
Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
Detailed description:
A Multicenter,Randomized,open-label,Phase II Study to Evaluate the Efficacy and Safety of
Vebreltinib Plus PLB1004 as the First-line Therapy for Patients with EGFRm+(exon 19
deletion or exon 21 L858R)/MET+ Locally Advanced or Metastatic Non-small Cell Lung
Cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Ability to understand and willingness to sign a written informed consent document.
2. Aged at least 18 years old.
3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC
(stage IIIB~IV).
4. Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and
MET overexpression (IHC 3+) .
5. At least one measurable lesion as defined by RECIST V1.1.
6. ECOG performance status 0 to 1.
Exclusion Criteria:
1. There are mutations of ALK or ROS1.
2. Have symptomatic and neurologically unstable central nervous system (CNS) metastases
or CNS disease that requires increased steroid doses for control.
3. Pregnant or nursing women.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinji Yang, MD
Phone:
+86-20-83827812
Email:
yangjinji@gdph.org.cn
Start date:
August 7, 2024
Completion date:
July 31, 2027
Lead sponsor:
Agency:
Avistone Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Avistone Biotechnology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06574347
