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

NCT06334757 | Unknown Phase 2

• 1 other identifier: HLX10IIT22
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• PFS(Progression Free Survival)

  From start of treatment to 24 months

• OS(Overall Survival)

  From start of treatment to 24 months

• AE(Adverse Event)

  From start of treatment to 24 months

Study Arms (1)

Serplulimab+Bevacizumab+Pemetrexed+Carboplatin

EXPERIMENTAL

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

Interventions

Serplulimab DRUG

300 mg，IV，Q3W

Also known as: HLX10

Serplulimab+Bevacizumab+Pemetrexed+Carboplatin

Bevacizumab Biosimilar HLX04 DRUG

7.5 mg/kg，Q3W

Also known as: HLX04

Serplulimab+Bevacizumab+Pemetrexed+Carboplatin

Pemetrexed DRUG

500 mg/m2，IV，Q3W

Serplulimab+Bevacizumab+Pemetrexed+Carboplatin

Carboplatin DRUG

AUC=5，IV，Q3W

Serplulimab+Bevacizumab+Pemetrexed+Carboplatin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent before any trial-related processes;
• Age ≥ 18 years and ≤70 years male or females;
• 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;
• Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment
• EGFR-TKI resistance, confirmed by RECIST 1.1
• The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;

You may not qualify if:

• History of severe allergies to any study drug
• 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
• Previous exposure to VEGF inhibitor for anti-cancer treatment
• 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.
• Has received a live-virus vaccination within 28 days of planned treatment start
• 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

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

MeSH Terms

Interventions

Pemetrexed; Carboplatin

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Central Study Contacts

zhen he

CONTACT

+86 13523530961; 13523530961@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: May 8, 2023
• Primary Completion: August 31, 2024
• Study Completion: June 30, 2025
• Last Updated: March 28, 2024

Record last verified: 2023-04

Locations

CN (1)