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Trial Title:
Serplulimab Plus Bevacizumab and Chemotherapy for EGFR-mutant Metastatic NSCLC Patients After EGFR-TKI Treatment Failure
NCT ID:
NCT06334757
Condition:
Non-Squamous Non-Small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Bevacizumab
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
300 mg，IV，Q3W
Arm group label:
Serplulimab+Bevacizumab+Pemetrexed+Carboplatin
Other name:
HLX10
Intervention type:
Drug
Intervention name:
Bevacizumab Biosimilar HLX04
Description:
7.5 mg/kg，Q3W
Arm group label:
Serplulimab+Bevacizumab+Pemetrexed+Carboplatin
Other name:
HLX04
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
500 mg/m2，IV，Q3W
Arm group label:
Serplulimab+Bevacizumab+Pemetrexed+Carboplatin
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
AUC=5，IV，Q3W
Arm group label:
Serplulimab+Bevacizumab+Pemetrexed+Carboplatin
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
zhen he
Phone:
13523530961
Start date:
May 8, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06334757
