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

Henan Cancer Hospital

Status and phase: Enrolling; Phase 2

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Bevacizumab Biosimilar HLX04; Drug: Carboplatin; Drug: Pemetrexed; Drug: Serplulimab

Study type: Interventional

Funder types: Other

Identifiers

NCT06334757

HLX10IIT22

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Serplulimab+Bevacizumab+Pemetrexed+Carboplatin

Experimental group

Description:

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.

Treatment:

Drug: Serplulimab

Drug: Carboplatin

Drug: Pemetrexed

Drug: Bevacizumab Biosimilar HLX04