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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Serplulimab Plus Bevacizumab and Chemotherapy for EGFRm+ Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334757
• Other study ID #: HLX10IIT22
• Status: Recruiting
• Phase: Phase 2
• Start date: May 8, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2023
• Source: Henan Cancer Hospital
• Contact: zhen he
• Phone: +86 13523530961
• Email: 13523530961[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: June 30, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Squamous Non-Small Cell Lung Cancer

Intervention

Drug:
• Serplulimab
300 mg,IV,Q3W
• Bevacizumab Biosimilar HLX04
7.5 mg/kg,Q3W
• Pemetrexed
500 mg/m2,IV,Q3W
• Carboplatin
AUC=5,IV,Q3W

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR(Overall Response Rate)	The proportion of subjects who have a complete response (CR) or a partial response (PR)	From start of treatment to 12 months
Secondary	PFS(Progression Free Survival)	Time from enrollment to first disease progression assessed by investigator or death due to any cause	From start of treatment to 24 months
Secondary	OS(Overall Survival)	Time from enrollment to the death of the subject due to any cause	From start of treatment to 24 months
Secondary	AE(Adverse Event)	incidece of adverse drug event	From start of treatment to 24 months