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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-Squamous Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Serplulimab; Drug: Bevacizumab Biosimilar HLX04; Drug: Pemetrexed; Drug: Carboplatin

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: zhen he; Phone Number: +86 13523530961; Email: 13523530961@126.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Cancer Hospital
      • Contact: zhen he; Phone Number: 13523530961

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Serplulimab; 300 mg，IV，Q3W; Other Names: HLX10; Drug: Bevacizumab Biosimilar HLX04; 7.5 mg/kg，Q3W; Other Names: HLX04; Drug: Pemetrexed; 500 mg/m2，IV，Q3W; Drug: Carboplatin; AUC=5，IV，Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
OS(Overall Survival)	Time from enrollment to the death of the subject due to any cause	From start of treatment to 24 months
AE(Adverse Event)	incidece of adverse drug event	From start of treatment to 24 months

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Folic Acid Antagonists; Carboplatin; Bevacizumab; Pemetrexed
• Other Study ID Numbers: HLX10IIT22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No