A Study to Evaluate the Efficacy and Safety of HLX07 in nsqNSCLC Patients With High EGFR Expression
An Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Advanced nsqNSCLC Patients With High EGFR Expression
1 other identifier
interventional
60
1 country
1
Brief Summary
An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Combination with Chemotherapy or Monotherapy in Advanced Non-squamous Non-small Cell Lung Cancer (nsqNSCLC) Patients with High EGFR Expression
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2022
CompletedFirst Posted
Study publicly available on registry
January 31, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2024
CompletedJuly 6, 2022
May 1, 2022
5 months
January 18, 2022
July 5, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
ORR
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
up to 2 years
PFS
Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1
from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Secondary Outcomes (1)
OS
from the date of first dose until the date of death from any cause，assessed up to 2 years
Study Arms (3)
A
EXPERIMENTALB
EXPERIMENTALC
EXPERIMENTALInterventions
HLX07 1500mg q3w+carboplatin+pemetrexed
Eligibility Criteria
You may qualify if:
- Age\>=18Y
- Good Organ Function
- Expected survival time ≥ 3 months
- Histologically confirmed, advanced/recurrent or metastatic nsqNSCLC
- Measurable lesion according RECISTv1.1 by investigator
- High EGFR expression H score ≥200
- ECOG score 0-1
You may not qualify if:
- Previous treatment with EGFR inhibitors
- Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- Active clinical severe infection;
- A history of other malignancies within 5 years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin,etal.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Chest Hospital
Shanghai, China
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2022
First Posted
January 31, 2022
Study Start
February 1, 2023
Primary Completion
July 15, 2023
Study Completion
August 10, 2024
Last Updated
July 6, 2022
Record last verified: 2022-05