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A Study to Evaluate the Efficacy and Safety of HLX07 in nsqNSCLC Patients With High EGFR Expression | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

NCT05215925•Shanghai Henlius Biotech

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Shanghai Chest Hospital

Shanghai, China

Key Dates

Start Date

February 1, 2023

Primary Completion Date

July 15, 2023

Completion Date

August 10, 2024

Last Updated

July 6, 2022

Enrollment

ESTIMATED participants

Conditions

HLX07, nsqNSCLC, High EGFR Expression

Interventions

HLX07+carboplatin+pemetrexed

DRUG

HLX07+docetaxel

DRUG

HLX07

DRUG

Contacts

baohui han, phD

CONTACT

021-22200000 hanxkyy@aliyun.com