Back to resultsEfficacy and Safety of Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in Lung Adenocarcinoma
Primary Purpose
Lung Adenocarcinoma Stage IV
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Sponsored by
About this trial
This is an interventional treatment trial for Lung Adenocarcinoma Stage IV
Eligibility Criteria
Inclusion Criteria:
- lung adenocarcinoma stage Ⅳ(according AJCC 8)
- received EGFR-TKI for 1 line and disease progression
- EGFR T790M negative
- ECOG PS 0-1
Exclusion Criteria:
- histology of mixed NSCLC with squamous cell carcinoma, neuroendocrine carcinoma and small cell carcinoma.
- have received checkpoint inhibitor.
- uncontrolled pleural effusion, pericardial effusion, or ascites after appropriate intervention
- any unstable systemic disease
- patients who were treated with systemic glucocorticoids (>10mg/ day prednisone therapeutic dose) or other immunosuppressive drugs within 14 days prior to the initial administration or during the study period
Sites / Locations
- Zhou Chengzhi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Tislelizumab (200mg,Q3W )+Bevacizumab(15 mg/kg,Q3W)+Albumin paclitaxel(100mg/m2,d1,8,15) for 4 cycles, and if there is no disease progression, patients will receive Tislelizumab(200mg,Q3W) until progression or death.
Outcomes
Primary Outcome Measures
PFS rate
rate of progression free survical in one year
Safety of Tislelizumab
TEAE are adverse events that occur during or after the first administration of the study drug until 30 days after the study drug is discontinued or the new anticancer treatment is initiated or worse than at baseline (before treatment)
Secondary Outcome Measures
ORR
objective response rate
OS rate
rate of oversurvival rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04310943
Brief Title
Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in Lung Adenocarcinoma
Official Title
Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in the Treatment of Advanced Lung Adenocarcinoma: a Single-arm, Phase Ⅱ Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Anticipated)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhou Chengzhi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The single arm clinical study is to evaluate the efficacy and safety of Tislelizumab combined with Bevacizumab and albumin paclitaxel in the treatment of advanced lung adenocarcinoma. All of the patients were received EGFR-TKI therapy for 1 line and disease progression. The primary endpoint is one-year PFS rate and safety, the seconday endpoint is ORR and one-year OS rate.
Detailed Description
Patients who meet the inclusion criteria will receive Tislelizumab combined with Bevacizumab and albumin paclitaxel for 4 cycles. If there is no disease progression, the patient will continue to receive Tislelizumab maintenance therapy, until the disease progresses or death.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma Stage IV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Tislelizumab (200mg,Q3W )+Bevacizumab(15 mg/kg,Q3W)+Albumin paclitaxel(100mg/m2,d1,8,15) for 4 cycles, and if there is no disease progression, patients will receive Tislelizumab(200mg,Q3W) until progression or death.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
Albumin paclitaxel, Bevacizumab
Intervention Description
Tislelizumab, 200mg, Q3W ,use until disease progression
Primary Outcome Measure Information:
Title
PFS rate
Description
rate of progression free survical in one year
Time Frame
one year
Title
Safety of Tislelizumab
Description
TEAE are adverse events that occur during or after the first administration of the study drug until 30 days after the study drug is discontinued or the new anticancer treatment is initiated or worse than at baseline (before treatment)
Time Frame
30 days after the trial finished
Secondary Outcome Measure Information:
Title
ORR
Description
objective response rate
Time Frame
one year
Title
OS rate
Description
rate of oversurvival rate
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lung adenocarcinoma stage Ⅳ(according AJCC 8)
received EGFR-TKI for 1 line and disease progression
EGFR T790M negative
ECOG PS 0-1
Exclusion Criteria:
histology of mixed NSCLC with squamous cell carcinoma, neuroendocrine carcinoma and small cell carcinoma.
have received checkpoint inhibitor.
uncontrolled pleural effusion, pericardial effusion, or ascites after appropriate intervention
any unstable systemic disease
patients who were treated with systemic glucocorticoids (>10mg/ day prednisone therapeutic dose) or other immunosuppressive drugs within 14 days prior to the initial administration or during the study period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou Chengzhi, Doctor
Phone
(+86)13560351186
Email
doctorzcz@163.com
Facility Information:
Facility Name
Zhou Chengzhi
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengzhi Zhou, Professor
Phone
13560351186
Email
doctorzcz@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23890065
Citation
Zitvogel L, Galluzzi L, Smyth MJ, Kroemer G. Mechanism of action of conventional and targeted anticancer therapies: reinstating immunosurveillance. Immunity. 2013 Jul 25;39(1):74-88. doi: 10.1016/j.immuni.2013.06.014.
Results Reference
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PubMed Identifier
27571927
Citation
Wallin JJ, Bendell JC, Funke R, Sznol M, Korski K, Jones S, Hernandez G, Mier J, He X, Hodi FS, Denker M, Leveque V, Canamero M, Babitski G, Koeppen H, Ziai J, Sharma N, Gaire F, Chen DS, Waterkamp D, Hegde PS, McDermott DF. Atezolizumab in combination with bevacizumab enhances antigen-specific T-cell migration in metastatic renal cell carcinoma. Nat Commun. 2016 Aug 30;7:12624. doi: 10.1038/ncomms12624.
Results Reference
background
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Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in Lung Adenocarcinoma
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