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Trial Title:
Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI
NCT ID:
NCT06343064
Condition:
Non-Small-Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Non-Small-Cell Lung Cancer
EGFR
NSCLC
Lung Cancer
MET Amplified
MET Expression
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Vebreltinib
Description:
Phase Ib is a dose escalation study, the initial dose of Vebreltinib is
100mg/150mg/200mg,according to the result of Phase Ib, will confirm the RP2D.
Arm group label:
Phase II:Cohort 1
Arm group label:
Phase II:Cohort 2
Arm group label:
Phase II:Cohort 3
Arm group label:
Phase Ib:Vebreltinib 100mg/150mg/200mg BID + PLB1004 80mg/160mg QD
Other name:
Bozitinib
Other name:
PLB1001
Intervention type:
Drug
Intervention name:
PLB1004
Description:
Phase Ib is a dose escalation study, the initial dose of PLB1004 is 80mg/160mg,according
to the result of Phase Ib, will confirm the RP2D.
Arm group label:
Phase II:Cohort 1
Arm group label:
Phase II:Cohort 2
Arm group label:
Phase II:Cohort 3
Arm group label:
Phase Ib:Vebreltinib 100mg/150mg/200mg BID + PLB1004 80mg/160mg QD
Summary:
Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET
Amplified or MET Expression in NSCLC
Detailed description:
Open label, multicenter Phase Ib/II clinical study to evaluate the safety, efficacy, and
pharmacokinetics of Vebreltinib in combination with PLB1004 in patients with locally
advanced or metastatic non-small cell lung cancer with MET overexpression or MET
amplification following EGFR-TKI treatment failure.
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. EGFR mutations, including exon 19 deletion and exon 21 L858R.
5. C-Met overexpression and/or c-Met amplification confirmed after treatment with
EGFR-TKI.
6. At least one measurable lesion as defined by RECIST V1.1.
7. ECOG performance status 0 to 1.
Exclusion Criteria:
1. Previous treatment with MET inhibitors or HGF-targeted therapy.
2. There are mutations of ALK or ROS1.
3. Have symptomatic and neurologically unstable central nervous system (CNS) metastases
or CNS disease that requires increased steroid doses for control.
4. Pregnant or nursing women.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Caichun Zhou, PHD
Phone:
+86-21-65115006
Email:
caicunzhoudr@163.com
Start date:
June 13, 2023
Completion date:
June 30, 2025
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/NCT06343064
