HLX07, nsqNSCLC, High EGFR Expression
Conditions
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
Interventions
DRUGHLX07+carboplatin+pemetrexed
HLX07 1500mg q3w+carboplatin+pemetrexed
DRUGHLX07+docetaxel
HLX07 1500mg q3w+docetaxel
DRUGHLX07
HLX07 1500mg q3w
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age\>=18Y 2. Good Organ Function 3. Expected survival time ≥ 3 months 4. Histologically confirmed, advanced/recurrent or metastatic nsqNSCLC 5. Measurable lesion according RECISTv1.1 by investigator 6. High EGFR expression H score ≥200 7. ECOG score 0-1
Exclusion criteria
1. 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. 2. Previous treatment with EGFR inhibitors 3. 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). 4. Active clinical severe infection; 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | up to 2 years | Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1) |
| PFS | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years | Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | from the date of first dose until the date of death from any cause，assessed up to 2 years | Overall survival |
Countries
China
Contacts
Primary Contactbaohui han, phD
Outcome results
None listed