A Study to Evaluate the Efficacy and Safety of HLX07 in nsqNSCLC Patients With High EGFR Expression

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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HLX07, nsqNSCLC, High EGFR Expression

Intervention / Treatment
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* Drug: HLX07+carboplatin+pemetrexed
* Drug: HLX07+docetaxel
* Drug: HLX07


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: HLX07+carboplatin+pemetrexed<br>* HLX07 1500mg q3w+carboplatin+pemetrexed<br>* Other names: Anti-EGFR Monoclonal Antibody;|
| Experimental: B<br> | Drug: HLX07+docetaxel<br>* HLX07 1500mg q3w+docetaxel<br>|
| Experimental: C<br> | Drug: HLX07<br>* HLX07 1500mg q3w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | from the date of first dose until the date of death from any cause，assessed up to 2 years |