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RecruitingNCT06334757Updated Mar 28, 2024

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

A Phase 2 interventional study of Serplulimab and Bevacizumab Biosimilar HLX04 in Non-Squamous Non-Small Cell Lung Cancer, sponsored by Henan Cancer Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Henan Cancer Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Registered 10 months after the study started (first participant enrolled May 2023, registered Mar 2024).
  • Started May 2023; still recruiting 3 years 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Squamous Non-Small Cell Lung Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 46 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (estimated)

Study arms

  • 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 · Drug: Bevacizumab Biosimilar HLX04 · Drug: Pemetrexed · Drug: Carboplatin

Interventions

  • DrugSerplulimab

    300 mg，IV，Q3W

    Also known as: HLX10

  • DrugBevacizumab Biosimilar HLX04

    7.5 mg/kg，Q3W

    Also known as: HLX04

  • DrugPemetrexed

    500 mg/m2，IV，Q3W

  • DrugCarboplatin

    AUC=5，IV，Q3W

06

What researchers measure

Primary outcomes

  1. ORR(Overall Response Rate)

    The proportion of subjects who have a complete response (CR) or a partial response (PR)

    Time frame: From start of treatment to 12 months

Secondary outcomes

  1. PFS(Progression Free Survival)

    Time from enrollment to first disease progression assessed by investigator or death due to any cause

    Time frame: From start of treatment to 24 months

  2. OS(Overall Survival)

    Time from enrollment to the death of the subject due to any cause

    Time frame: From start of treatment to 24 months

  3. AE(Adverse Event)

    incidece of adverse drug event

    Time frame: From start of treatment to 24 months

07

Study locations

1 of 1 sites recruiting
  • Henan Cancer Hospital
    Zhengzhou, Henan 450003, China
    • zhen he · Contact · 13523530961
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06334757
Lead sponsor
Henan Cancer Hospital
Responsible party
Sponsor
First posted
Mar 28, 2024
Start date
May 8, 2023
Primary completion
Aug 31, 2024 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Mar 28, 2024

Study contacts

zhen he
Contact
13523530961@126.com
+86 13523530961

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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