Non-Squamous Non-Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGSerplulimab
300 mg，IV，Q3W
DRUGBevacizumab Biosimilar HLX04
7.5 mg/kg，Q3W
DRUGPemetrexed
500 mg/m2，IV，Q3W
DRUGCarboplatin
AUC=5，IV，Q3W
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR(Overall Response Rate) | From start of treatment to 12 months | The proportion of subjects who have a complete response (CR) or a partial response (PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS(Progression Free Survival) | From start of treatment to 24 months | Time from enrollment to first disease progression assessed by investigator or death due to any cause |
| OS(Overall Survival) | From start of treatment to 24 months | Time from enrollment to the death of the subject due to any cause |
| AE(Adverse Event) | From start of treatment to 24 months | incidece of adverse drug event |
Countries
China
Contacts
Primary Contactzhen he
Outcome results
None listed