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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-08-10

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

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Detailed Description

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Conditions

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HLX07, nsqNSCLC, High EGFR Expression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

HLX07+carboplatin+pemetrexed

Intervention Type DRUG

HLX07 1500mg q3w+carboplatin+pemetrexed

B

Group Type EXPERIMENTAL

HLX07+docetaxel

Intervention Type DRUG

HLX07 1500mg q3w+docetaxel

C

Group Type EXPERIMENTAL

HLX07

Intervention Type DRUG

HLX07 1500mg q3w

Interventions

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HLX07+carboplatin+pemetrexed

HLX07 1500mg q3w+carboplatin+pemetrexed

Intervention Type DRUG

HLX07+docetaxel

HLX07 1500mg q3w+docetaxel

Intervention Type DRUG

HLX07

HLX07 1500mg q3w

Intervention Type DRUG

Other Intervention Names

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Anti-EGFR Monoclonal Antibody

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No