Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05648071
Status:
RECRUITING
Last Update Posted:
2022-12-13
First Post:
2022-12-04
Brief Title:
First-Line Treatment for Advanced Non-squamous Non-Small-Cell Lung Cancer With Negative Driver Gene a Single-center Single-Arm Trial
Sponsor:
Qianfoshan Hospital
Organization:
Qianfoshan Hospital
Study Overview
Official Title:
Sintilimab Plus Bevacizumab and Platinum-Based Doublet Chemotherapy as First-Line Treatment for Advanced Non-squamous Non-Small-Cell Lung Cancer With Negative Driver Gene a Single-center Single-Arm Trial
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPBPDC
Brief Summary:
To evaluate the efficacy and safety of sintilimab plus bevacizumab and platinum-based doublet chemotherapy as the first-line therapy for advanced nonsquamous non-small-cell lung cancerNSCLC with negative driver gene
This study is an exploratory single-arm study The specific treatment regimen is as follows Non-squamous NSCLC Sintilimab 200 mg plus Bevacizumab 75mgkg is started on the first day of each treatment cycle and administered every three weeks Nedaplatin 80-100 mgm2 d2 pemetrexed 500 mgm2 d2 Q3W is administered in this regimen for 4 cycles followed by sintilimab plus bevacizumab until disease progression or intolerable toxicity
Patients are assessed for measurable disease at baseline 6 weeks 12 weeks after starting treatment and every 9 weeks thereafter according to RECIST 11 criteria during the treatment period until disease progression or intolerable toxicity withdrawal Following discontinuation of treatment subjects are followed for survival status every 3 months until death Subject safety was assessed during treatment according to NCI CTCAE Version 40 criteria Subjects who experience an AE should be followed until the AE returns to baseline The primary endpoints is Progression-free survival PFS Secondary endpoints include objective response rate ORR overall survival OS and safety NCI CTCAE v 40 Statistical methods The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed The confidence interval method was used as the criterion for the main analysis OS was calculated in the same way as the secondary endpoint Descriptive statistics will be used to analyze ORR DCR etc It is expected that sintilimab plus bevacizumab and platinum-based doublet chemotherapy as first-line treatment will prolong median PFS and OS in patients with driver gene-negative advanced Non-squamous NSCLC
This study is an exploratory single-arm study The specific treatment regimen is as follows Non-squamous NSCLC Sintilimab 200 mg plus Bevacizumab 75mgkg is started on the first day of each treatment cycle and administered every three weeks Nedaplatin 80-100 mgm2 d2 pemetrexed 500 mgm2 d2 Q3W is administered in this regimen for 4 cycles followed by sintilimab plus bevacizumab until disease progression or intolerable toxicity
Patients are assessed for measurable disease at baseline 6 weeks 12 weeks after starting treatment and every 9 weeks thereafter according to RECIST 11 criteria during the treatment period until disease progression or intolerable toxicity withdrawal Following discontinuation of treatment subjects are followed for survival status every 3 months until death Subject safety was assessed during treatment according to NCI CTCAE Version 40 criteria Subjects who experience an AE should be followed until the AE returns to baseline The primary endpoints is Progression-free survival PFS Secondary endpoints include objective response rate ORR overall survival OS and safety NCI CTCAE v 40 Statistical methods The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed The confidence interval method was used as the criterion for the main analysis OS was calculated in the same way as the secondary endpoint Descriptive statistics will be used to analyze ORR DCR etc It is expected that sintilimab plus bevacizumab and platinum-based doublet chemotherapy as first-line treatment will prolong median PFS and OS in patients with driver gene-negative advanced Non-squamous NSCLC
Detailed Description:
Lung cancer is the most common cause of cancer mortality worldwide1 NSCLC represents more than 80 of lung cancer cases2 with most having nonsquamous histology3Current first-line treatment options in metastatic nonsquamous NSCLC without oncogenic driver alterations include checkpoint inhibitor monotherapy in patients with high programmed death-ligand 1 PD-L1 expression and checkpoint inhibitor therapy in combination with platinum-doublet chemotherapy with or without bevacizumab45Despite the available standard-of-care first-line treatments clinical outcomes have remained suboptimal and additional therapeutic options are needed
Sintilimab is a recombinant fully human IgG4 anti-PD-1 monoclonal antibody Preclinical data have shown that sintilimab has a greater affinity against PD-1 than pembrolizumab or nivolumab6In a randomised double-blind phase 3 trial sintilimab plus chemotherapy resulted in significantly longer progression-free survival and overall survival versus chemotherapy alone in patients with treatment-naive NSCLC without EGFR or ALK genomic tumour mutations with a manageable safety profile78
Bevacizumab in addition to its known anti-angiogenic effects has immunomodulatory effects through inhibition of vascular endothelial growth factor VEGF including promotion of dendritic cell maturation normalisation of the tumour vasculature which might increase T-cell infiltration and reprogramming of the tumour microenvironment from being immune suppressive to immune permissive910 Therefore reversal of VEGF-mediated immunosuppression by bevacizumab could enhance the antitumour activity of sintilimab
We aimed to evaluate the efficacy and safety of sintilimab with bevacizumab plus platinum-based doublet chemotherapy for the treatment of patients with driver gene-negative advanced nonsquamous NSCLC
Objective To evaluate the efficacy and safety of sintilimab plus bevacizumab and platinum-based doublet chemotherapy as the first-line therapy for advanced nonsquamous non-small-cell lung cancer with negative driver gene
The research idea starts from the safety and efficacy of sintilimab plus bevacizumab and platinum-based doublet chemotherapy for NSCLC Under the theoretical perspective of clinical research on cancer treatment an exploratory single-center single-arm study method is used to perform sintilimab plus bevacizumab and platinum-based doublet chemotherapy regimen for first-line treatment of advanced nonsquamous NSCLC patients with negative driver gene A database is established for the enrolled case report form systematic data analysis is performed and finally the study conclusions of above treatment safety and efficacy are obtained It is expected that sintilimab plus bevacizumab and platinum-based doublet chemotherapy as first-line treatment will prolong median PFS and OS in patients with driver gene-negative advanced nonsquamous NSCLC
This study is an exploratory single-arm study The specific treatment regimen is as follows Non-squamous NSCLC Sintilimab 200 mg plus Bevacizumab 75mgkg is started on the first day of each treatment cycle and administered every three weeks Nedaplatin 80-100 mgm2 d2 pemetrexed 500 mgm2 d2 Q3W is administered in this regimen for 4 cycles followed by sintilimab plus Bevacizumab until disease progression or intolerable toxicity
Patients are assessed for measurable disease at baseline 6 weeks 12 weeks after starting treatment and every 9 weeks thereafter according to RECIST11 criteria during the treatment period until disease progression or intolerable toxicity withdrawal Following discontinuation of treatment subjects are followed for survival status every 3 months until death Subject safety was assessed during treatment according to NCI CTCAE Version 40 criteria Subjects who experience an AE should be followed until the AE returns to baseline The primary endpoints is Progression-free survival PFS Secondary endpoints include objective response rate ORR overall survival OS and safety NCI CTCAE v 40
Statistical methods The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed The confidence interval method was used as the criterion for the main analysis OS was calculated in the same way as the secondary endpoint Descriptive statistics will be used to analyze ORR DCR etc
Sintilimab is a recombinant fully human IgG4 anti-PD-1 monoclonal antibody Preclinical data have shown that sintilimab has a greater affinity against PD-1 than pembrolizumab or nivolumab6In a randomised double-blind phase 3 trial sintilimab plus chemotherapy resulted in significantly longer progression-free survival and overall survival versus chemotherapy alone in patients with treatment-naive NSCLC without EGFR or ALK genomic tumour mutations with a manageable safety profile78
Bevacizumab in addition to its known anti-angiogenic effects has immunomodulatory effects through inhibition of vascular endothelial growth factor VEGF including promotion of dendritic cell maturation normalisation of the tumour vasculature which might increase T-cell infiltration and reprogramming of the tumour microenvironment from being immune suppressive to immune permissive910 Therefore reversal of VEGF-mediated immunosuppression by bevacizumab could enhance the antitumour activity of sintilimab
We aimed to evaluate the efficacy and safety of sintilimab with bevacizumab plus platinum-based doublet chemotherapy for the treatment of patients with driver gene-negative advanced nonsquamous NSCLC
Objective To evaluate the efficacy and safety of sintilimab plus bevacizumab and platinum-based doublet chemotherapy as the first-line therapy for advanced nonsquamous non-small-cell lung cancer with negative driver gene
The research idea starts from the safety and efficacy of sintilimab plus bevacizumab and platinum-based doublet chemotherapy for NSCLC Under the theoretical perspective of clinical research on cancer treatment an exploratory single-center single-arm study method is used to perform sintilimab plus bevacizumab and platinum-based doublet chemotherapy regimen for first-line treatment of advanced nonsquamous NSCLC patients with negative driver gene A database is established for the enrolled case report form systematic data analysis is performed and finally the study conclusions of above treatment safety and efficacy are obtained It is expected that sintilimab plus bevacizumab and platinum-based doublet chemotherapy as first-line treatment will prolong median PFS and OS in patients with driver gene-negative advanced nonsquamous NSCLC
This study is an exploratory single-arm study The specific treatment regimen is as follows Non-squamous NSCLC Sintilimab 200 mg plus Bevacizumab 75mgkg is started on the first day of each treatment cycle and administered every three weeks Nedaplatin 80-100 mgm2 d2 pemetrexed 500 mgm2 d2 Q3W is administered in this regimen for 4 cycles followed by sintilimab plus Bevacizumab until disease progression or intolerable toxicity
Patients are assessed for measurable disease at baseline 6 weeks 12 weeks after starting treatment and every 9 weeks thereafter according to RECIST11 criteria during the treatment period until disease progression or intolerable toxicity withdrawal Following discontinuation of treatment subjects are followed for survival status every 3 months until death Subject safety was assessed during treatment according to NCI CTCAE Version 40 criteria Subjects who experience an AE should be followed until the AE returns to baseline The primary endpoints is Progression-free survival PFS Secondary endpoints include objective response rate ORR overall survival OS and safety NCI CTCAE v 40
Statistical methods The PFS curve was estimated using the Kaplan-Meier method for the largest population to be analyzed The confidence interval method was used as the criterion for the main analysis OS was calculated in the same way as the secondary endpoint Descriptive statistics will be used to analyze ORR DCR etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None