Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690686
Status:
UNKNOWN
Last Update Posted:
2022-03-08
First Post:
2020-10-23
Brief Title:
Immunopheresis Alone or in Combination With Paclitaxel or Atezolizumab in Non-small Cell Lung Cancer NSCLC
Sponsor:
Immunicom Inc
Organization:
Immunicom Inc
Study Overview
Official Title:
Open-Label Study Evaluating the Safety and Effectiveness of Immunopheresis With the LW-02 Column Alone or in Combination With Paclitaxel or Atezolizumab in Removing Soluble Tumor Necrosis Factor Receptors to Treat Patients With Advanced Non-Small Cell Lung Cancer NSCLC
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
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:
None
Brief Summary:
This pilot study aims to evaluate the short-term and long-term safety tolerability and effectiveness of immunopheresis with the LW-02 column in removal of sTNFRs from plasma of patients with advanced refractory NSCLC and to detect a potential disease control signal when employed in combination with low dose chemotherapy ie paclitaxel immunotherapy ie atezolizumab in patients who already failed first-line therapy or as monotherapy in patients who already have failed second-line therapy
Detailed Description:
This is an open-label Phase 2a pilot study of Immunicoms LW-02 column- combined with low-dose chemotherapy or immunotherapy in patients who have failed first-line treatment or employed as monotherapy in patients who have failed second-line therapy-to evaluate the short-term and long-term safety tolerability and effectiveness of these approaches in removing sTNF-Rs and the potential for disease control in advanced refractory NSCLC patients Along with LW-02 column immunopheresis patients enrolled in Arm 1 will receive combination immunotherapy with atezolizumab and patients enrolled in Arm 2 also will receive combination chemotherapy with paclitaxel Patients in Arm 3 will be treated with LW-02 column immunopheresis alone as a third-line treatment regimen assuming the first-line treatment included a platinum salt Following study qualification patients will be assigned to the appropriate treatment All patients may receive up to 48 LW-02 column-based immunopheresis treatments over a 16-week 4-month period with up to 3 treatments per week Importantly each LW-02 immunopheresis treatment should last up to 3 hours and process approximately 2 times the patients plasma volume 2PV
Each patient assigned to the treatment with LW-02 column-based immunopheresis will require central vascular access for the procedure In general a cuffed tunneled dual-lumen catheter will be inserted into a central vein and remain in situ throughout the 16-week treatment phase or longer if additional treatment is clinically indicated The catheter will be used to connect the inlet and return lines of the apheresis system to the patient Immunopheresis treatments will be performed using the LW-02 column used inline with a centrifugal apheresis system that allows for secondary plasma processing system eg the Terumo BCT Spectra Optia Apheresis System or alternate apheresis system Proper anticoagulation of the centrifugal apheresis device is generally provided by utilizing acid citrate dextrose formula A ACD-A
Patients will be followed and clinically evaluated for two-years posttreatment In Year 1 patients will be clinically evaluated at 3 6 9 and 12 months from the end-of-treatment EOT visit In Year 2 quarterly every 3 months telephone contacts will be made to determine overall survival
Each patient assigned to the treatment with LW-02 column-based immunopheresis will require central vascular access for the procedure In general a cuffed tunneled dual-lumen catheter will be inserted into a central vein and remain in situ throughout the 16-week treatment phase or longer if additional treatment is clinically indicated The catheter will be used to connect the inlet and return lines of the apheresis system to the patient Immunopheresis treatments will be performed using the LW-02 column used inline with a centrifugal apheresis system that allows for secondary plasma processing system eg the Terumo BCT Spectra Optia Apheresis System or alternate apheresis system Proper anticoagulation of the centrifugal apheresis device is generally provided by utilizing acid citrate dextrose formula A ACD-A
Patients will be followed and clinically evaluated for two-years posttreatment In Year 1 patients will be clinically evaluated at 3 6 9 and 12 months from the end-of-treatment EOT visit In Year 2 quarterly every 3 months telephone contacts will be made to determine overall survival
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