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

Phase 2

• Conditions: HLX07, nsqNSCLC, High EGFR Expression
• Interventions: Drug: HLX07+carboplatin+pemetrexed; Drug: HLX07+docetaxel; Drug: HLX07

• Registration Number: NCT05215925
• Lead Sponsor: Shanghai Henlius Biotech

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-18
• Study First Submitted QC: 2022-01-18
• Study First Posted: 2022-01-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-06
• Study Start: 2023-02-01
• Primary Completion: 2023-07-15
• Study Completion: 2024-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	HLX07+carboplatin+pemetrexed	-
B	HLX07+docetaxel	-
C	HLX07	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
OS	from the date of first dose until the date of death from any cause，assessed up to 2 years	Overall survival

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China