Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure

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

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-08

Study Completion Date

2025-06-30

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of Serplulimab Plus Bevacizumab and chemotherapy in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients.

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Detailed Description

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Conditions

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Non-Squamous Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Serplulimab+Bevacizumab+Pemetrexed+Carboplatin

Using Serplulimab in combination with bevacizumab, carboplatin and pemetrexed to treat patients with EGFR mutated, advanced non-small cell lung cancer (NSCLC) after failure of EGFR tyrosine kinase inhibitors.

Group Type EXPERIMENTAL

Serplulimab

Intervention Type DRUG

300 mg，IV，Q3W

Bevacizumab Biosimilar HLX04

Intervention Type DRUG

7.5 mg/kg，Q3W

Pemetrexed

Intervention Type DRUG

500 mg/m2，IV，Q3W

Carboplatin

Intervention Type DRUG

AUC=5，IV，Q3W

Interventions

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Serplulimab

300 mg，IV，Q3W

Intervention Type DRUG

Bevacizumab Biosimilar HLX04

7.5 mg/kg，Q3W

Intervention Type DRUG

Pemetrexed

500 mg/m2，IV，Q3W

Intervention Type DRUG

Carboplatin

AUC=5，IV，Q3W

Intervention Type DRUG

Other Intervention Names

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HLX10 HLX04

Eligibility Criteria

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Inclusion Criteria

1. Signed written informed consent before any trial-related processes;
2. Age ≥ 18 years and ≤70 years male or females;
3. Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer \[AJCC\] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;
4. Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment
5. EGFR-TKI resistance, confirmed by RECIST 1.1
6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;

Exclusion Criteria

1. History of severe allergies to any study drug
2. Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other stimulatory or inhibitory agents of T cell receptors
3. Previous exposure to VEGF inhibitor for anti-cancer treatment
4. Patients with untreated symptomatic brain metastases. Patients with treated brain metastases will be allowed if brain imaging obtained greater than 4 weeks from trial enrollment reveals stable disease.
5. Has received a live-virus vaccination within 28 days of planned treatment start
6. Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No