Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of HLX07 in nsqNSCLC Patients With High EGFR Expression
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
HLX07, nsqNSCLC, High EGFR Expression
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Mo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Histologically, squamous NSCLC should be excluded. For tumors with adenocarcinoma and squamous carcinoma, if the adenoid component is dominant and the squamous component is \< 5%, the patients meet the inclusion requirements.
- 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.
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 10 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05215925
Start Date
February 1 2023
End Date
August 10 2024
Last Update
July 6 2022
Active Locations (1)
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1
Shanghai Chest Hospital
Shanghai, China