Non Small Cell Lung CancerPhase 2NCT04690686
Immunopheresis Alone or in Combination With Paclitaxel or Atezolizumab in Non-small Cell Lung Cancer (NSCLC).
A Phase 2 study testing LW-02 device immunopheresis combined with atezolizumab, LW-02 device immunopheresis combined with weekly paclitaxel and LW-02 device immunopheresis in people with Non Small Cell Lung Cancer, run by Immunicom Inc at 3 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- LW-02 device immunopheresis combined with atezolizumab, LW-02 device immunopheresis combined with weekly paclitaxel and LW-02 device immunopheresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients who meet any of the following criteria will be excluded from study entry:
- Symptomatic CNS metastases
- Leptomeningeal disease
- Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
- Previous use of paclitaxel (not applicable for patients enrolled in Arm 3).
- Pregnant or lactating or intending to become pregnant during the study or for at least 5 months after the least study treatment. Women who are not postmenopausal (postmenopausal defined as ≥ 12 months of non-drug-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 2 weeks prior to initiation of study treatment
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- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
- Significant cardiovascular disease, such as New York Heart Association cardiac disease ≥ Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina
- Patients with known coronary artery disease or left ventricular ejection fraction < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate
- Patient with known persistent, uncontrolled hypotension
- Significant renal disorder requiring dialysis or indication for renal transplant
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation
- Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
- Fever, or any active immunosuppressive systemic infection including history of human immunodeficiency virus (HIV) infection
- Other serious diseases (e.g., life expectancy less than 3 months) including active second malignancy except for basal cell carcinoma or cervical carcinoma in situ
- Active infection
- Patients in whom vascular access is not considered achievable
- Use of any standard high dose or low dose chemotherapy or immunosuppressive therapies and or standard radiation therapy concurrently as well anticipated need for any of the former during the study
- Body mass index (BMI) ≥ 35 kg/m2
- Any condition that the patient's physician determines to be detrimental to the patient participating in this study; including any clinically important abnormal clinical laboratory values or concurrent medical events
- Inability to understand the local language affecting the use of the patient QOL instruments.
- Need for regular treatment with an angiotensin converting enzyme (ACE) inhibitor during the study; patients should discontinue treatment at least 14 days prior to the first LW-02 column immunopheresis treatment.
- Additional exclusions for patients to be treated in Arm 1 (with atezolizumab):
- Previous use of atezolizumab.
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- History of autoimmune disease is allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks, with the exception of:
- Patients taking concurrent abatacept or belatacept treatment (prior therapy must have been withdrawn for > 8 weeks)
- Patients with a history of serious or life threatening immune-related events
- No more than 1 concomitant autoimmune disease at the time of study entry is allowed unless one of them is:
- Autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement hormone ii. Controlled Type I diabetes mellitus on a stable dose of insulin regimen iii. A medical history of such entities as atopic disease or childhood arthralgia, where the clinical suspicion of autoimmune disease is low. In addition, transient autoimmune manifestations of an acute infectious disease that resolved upon treatment of the infectious agent are not excluded (eg, acute Lyme arthritis) iv. Vitiligo.
- Prior allogeneic stem cell or solid organ transplantation
- History of idiopathic pulmonary fibrosis, including pneumonitis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- History of radiation pneumonitis in the radiation field (fibrosis) is permitted
- Active tuberculosis
- In patients who have a potentially high likelihood of latent tuberculosis (e.g., recent contact with an infectious carrier, residence in a locale with high TB burden), absence of Mycobacterium tuberculosis infection must be confirmed before enrollment according to local practice standards
- Administration of a live, attenuated vaccine within 4 weeks prior to study treatment initiation
- Influenza vaccination should be given during influenza season only (e.g., approximately October to March in the Northern Hemisphere).
- Patients must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to study treatment initiation or at any time during the study.
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies other than anti-PD-1 therapy, including anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferons or interleukin 2) within 4 weeks or five half-lives of the drug, whichever is longer, prior to initiation of study treatment
- Prior cancer vaccines and cellular immunotherapy are permitted
- Specifically for patients without autoimmune disease: treatment with systemic corticosteroids or other systemic immunosuppressive medications including, but not limited to: prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents within 2 weeks prior to study treatment initiation, or anticipated requirement for systemic immunosuppressive medications during the trial
- For patients with CNS metastases and lung cancer related dyspnea, use of prednisone at a stable dose (or dose equivalent) of ≤ 20 mg/day is acceptable.
- The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids (eg, fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency and topical steroids for cutaneous diseases are allowed.
Trial locations and contacts
3 sites in 1 country.
Adam Ostrowski, MD Medical Director, International - Immunicom, Inc. contact
Robert Segal, MD FACP Chief Medical Officer - Immunicom, Inc. contact
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Acibadem Atakent Hospital, Medical Oncology Department
Istanbul, Kucukcekmece, 34303
Mustafa Bozkurt, MD Investigaator, +(90)2124044444 ext. 4337, mustafa.bozkurt@acibadem.com
Murat Aşik, MD, +(90)2163142459, murat.asik@acibadem.com
- Recruiting
Acibadem Maslak Hospital, Medical Oncology Department - coordinating site
Istanbul, Sariyer, 34457
Prof. Gökhan Demir, MD Principal Investigator, +(90)2123044444, gokhan.demir@acibadem.com
Murat Aşik, MD, +(90)2163142459, murat.asik@acibadem.com
- Recruiting
Acibadem Altunizade Hospital, Mecical Oncology Department
Istanbul, Uskudar, 34662
Mehmet Teomete, MD Investigator, +(90)2166494444, mehmet.teomete@acibadem.com
Murat Aşik, MD, +(90)2163142459, murat.asik@acibadem.com
About this study
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)
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.
Read the detailed description
This is an open-label, Phase 2a pilot study of Immunicom's 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 patient's 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- LW-02 device immunopheresis combined with atezolizumab, LW-02 device immunopheresis combined with weekly paclitaxel, LW-02 device immunopheresis
- Keywords
- NSCLC, Advanced NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LW-02 device immunopheresis combined with atezolizumabDevice
Also called Plasma soluble TNF receptor pulldown + immunotherapy.
The LW-02 device comprises an immunoadsorption affinity column, employing a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses. In combined treatment arm the immunopheresis procedure is combined with standard dose immunotherapy (atezolizumab) to potentially enhancing its cytotoxic effect.
LW-02 device immunopheresis combined with weekly paclitaxelDevice
Also called Plasma soluble TNF receptor pulldown + chemotherapy
The LW-02 device comprises an immunoadsorption affinity column, employing a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses. In combined treatment arm the immunopheresis procedure is combined with low dose chemotherapy to potentially enhancing its cytotoxic effect.
LW-02 device immunopheresisDevice
Also called Plasma soluble TNF receptor pulldown
The LW-02 device comprises an immunoadsorption affinity column, employing a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses.
| Study group | Role | What they receive |
|---|---|---|
| LW-02 device immunopheresis combined with atezolizumab | Experimental | LW-02 column immunopheresis treatments ~3x/week for 16 weeks plus atezolizumab 1200 milligrams (mg) q3w until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first [N=8] Receives: Device: LW-02 device immunopheresis combined with atezolizumab |
| LW-02 device immunopheresis combined with weekly paclitaxel | Experimental | LW-02 column immunopheresis treatments ~3x/week for 16 weeks plus paclitaxel 80 mg/m2 /week × 6 followed by 2 weeks rest until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first. [N=8] Receives: Device: LW-02 device immunopheresis combined with weekly paclitaxel |
| LW-02 device immunopheresis | Experimental | LW-02 column immunopheresis treatments ~3x/week for 16 weeks alone until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first. [N=8] Receives: Device: LW-02 device immunopheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Treatment-Emergent Adverse Events which will be analysed in study ill be:
- Adverse Event (AE)
- Serious Adverse Events (SAE)
- Adverse Device Effect (ADE)
- Serious Adverse Device Effect (SADE) Each of the Treatment-Emergent Adverse Events will be assessed for their seriousness, severity [using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 v. 5.0] and causality (relationship with the use of the investigated medical device).
Measured: 16 weeks
Column performance effectiveness
Column efficiency and effectiveness in removal of sTNF-Rs from patient plasma without clinically-meaningful leaching of capture ligand (SC-TNF-α) - change in sTNF-R and TNF-α plasma levels from initiation to the end of each
LW-02 column perfornance effectiveness will be assessed to measure over 30 minutes (sTNF-Rs) and over the duration (leaching) of each procedure, respectively:
- Removal of soluble TNF receptor 1 (sTNF-R1)
- Removal of soluble TNF receptor 2 (sTNF-R2)
- Leaching of sc-TNF-α from the column
Measured: 16 weeks
Incidence of Treatment-Emergent Adverse Events of special interest.
Incidence of Treatment-Emergent Adverse Events of special interest assessment will include:
- tumor lysis syndrome and
- systemic inflammatory response syndrome. These events may or may not be serious and they may or may not be considered related to study treatment. Regardless of relationship or severity, these events will be recorded if they start after the first application of study treatment and will be followed until resolution.
Measured: 16 weeks
Secondary outcomes (10)
Patient functioninig with Eastern Cooperative Oncology Group (ECOG)
Eastern Cooperative Oncology Group (ECOG) scale describes patient's functioning in terms of ability to care for themselves, daily activity, and physical ability (walking, working). The scale grades 0 to 5 (0=fully active while and 5=dead).
Measured: 16 weeks
Quality of life assessment with EQ-5D-5L scale
EQ-5D-5L scale to assess: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels:
from no problems to extreme problems.
Measured: 16 weeks
Quality of life assessment with EORTC-QLQ-C30 scale
EORTC-QLQ-C30 scale measures cancer patients' physical, psychological and social functions. The EORTC QLQ-C30 comprises 30 items (i.e. single questions), 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).
Measured: 16 weeks
Quality of life assessment with EORTC-QLQ-LC29 scale
EORTC-QLQ-LC29 measuring the quality of life in patients with lung cancer. Each dimension in the scale has four response levels from not at all (1) to very much (4).
Measured: 16 weeks
Clinical endpoint - overall survival
A series of secondary efficacy outcome measures will be evaluated based on overall survival from the date of the first study treatment and changes in objective response using RECIST (1.1) or iRECIST criteria. The assessed parameters will be:
Overall Survival (OS). Overall survival ( OS ) is defined as the time from randomization to death from any cause, is a direct measure of clinical benefit to a patient.
Measured: 16 weeks
Clinical endpoint - progression free survival
A series of secondary efficacy outcome measures will be evaluated based on overall survival from the date of the first study treatment and changes in objective response using RECIST (1.1) or iRECIST criteria. The assessed parameters will be:
Progression Free Survival (PFS) Progression-free survival ( pfs ) is defined as time from randomization until first evidence of tumour progression or until death from any cause, whichever comes first.
Measured: 16 weeks
Clinical endpoint - disease control rate
A series of secondary efficacy outcome measures will be evaluated based on overall survival from the date of the first study treatment and changes in objective response using RECIST (1.1) or iRECIST criteria. The assessed parameters will be:
Disease Control Rate (DCR) Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity. In contrast, disease control rate is a composite of ORR and stable disease and is useful to measure the efficacy of therapies that have tumoristatic effects rather than tumoricidal effects.
Measured: 16 weeks
Nutritional status assessment
The Scored Patient-Generated Subjective Global Assessment (PG-SGA©) scale will be used. The Scored PG-SGA© includes the four patient-generated historical components (Weight History, Food Intake, Symptoms and Activities and Function - also known as the PG-SGA Short Form©), the professional part (Diagnosis, Age, Metabolic stress, and Physical Exam), the Global Assessment (A = well nourished, B = moderately malnourished or suspected malnutrition, C = severely malnourished) and the total numerical score.
Measured: 16 weeks
Physical performance status assessment with 6 minute walk test (6MWT)
The physical performance assessment will be measured with 6-minute walk test (6MWT).
6MWT meassures the distance patient covers when walking in a regular pace in standardized condition. The longer distance is expected in patients who improve while the poor patient performance and capability, the shorter distance will be measured.
Measured: 16 weeks
Muscle performance assessment with a hand grip test
The muscle performance assessment will be measured hand grip test. The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles. The participant will be asked to squeeze the dynamometer as hard as possible with each of his or her hands in a standing position. The subject squeezes the dynamometer with maximum isometric effort, which is maintained for about 5 seconds. Results for left and right hand separately are recorded in kilograms.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Oct 2020
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, phase 2a pilot study of Immunicom's LW-02 column-combined with low-dose chemotherapy or immunotherapy.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunicom Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Ostrowski, MD, Study director, Immunicom Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690686
- Sponsor's protocol ID
- CP7-008
- Status last verified
- Mar 2022
- First submitted
- 23 Oct 2020
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04690686
- Acronym / sponsor ID
- CP7-008
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, Advanced NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Immunicom IncIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Immunicom's 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 patient's 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-label, phase 2a pilot study of Immunicom's LW-02 column-combined with low-dose chemotherapy or immunotherapy.
| Arm | Type | Receives |
|---|---|---|
| LW-02 device immunopheresis combined with atezolizumab | Experimental | Device: LW-02 device immunopheresis combined with atezolizumabLW-02 column immunopheresis treatments ~3x/week for 16 weeks plus atezolizumab 1200 milligrams (mg) q3w until disease progression or loss of clinical benefit, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first [N=8] |
| LW-02 device immunopheresis combined with weekly paclitaxel | Experimental | Device: LW-02 device immunopheresis combined with weekly paclitaxelLW-02 column immunopheresis treatments ~3x/week for 16 weeks plus paclitaxel 80 mg/m2 /week × 6 followed by 2 weeks rest until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first. [N=8] |
| LW-02 device immunopheresis | Experimental | Device: LW-02 device immunopheresisLW-02 column immunopheresis treatments ~3x/week for 16 weeks alone until disease progression, death, unacceptable toxicity, withdrawal of consent, or study termination by sponsor, whichever occurs first. [N=8] |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (45 listed)
- Symptomatic CNS metastases
- Leptomeningeal disease
- Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
- Previous use of paclitaxel (not applicable for patients enrolled in Arm 3).
- Pregnant or lactating or intending to become pregnant during the study or for at least 5 months after the least study treatment. Women who are not postmenopausal (postmenopausal defined as ≥ 12 months of non-drug-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 2 weeks prior to initiation of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LW-02 device immunopheresis combined with atezolizumabAlso: Plasma soluble TNF receptor pulldown + immunotherapy.The LW-02 device comprises an immunoadsorption affinity column, employing a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses. In combined treatment arm the immunopheresis procedure is combined with standard dose immunotherapy (atezolizumab) to potentially enhancing its cytotoxic effect. | Device | LW-02 device immunopheresis combined with atezolizumab |
| LW-02 device immunopheresis combined with weekly paclitaxelAlso: Plasma soluble TNF receptor pulldown + chemotherapyThe LW-02 device comprises an immunoadsorption affinity column, employing a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses. In combined treatment arm the immunopheresis procedure is combined with low dose chemotherapy to potentially enhancing its cytotoxic effect. | Device | LW-02 device immunopheresis combined with weekly paclitaxel |
| LW-02 device immunopheresisAlso: Plasma soluble TNF receptor pulldownThe LW-02 device comprises an immunoadsorption affinity column, employing a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses. | Device | LW-02 device immunopheresis |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 16 weeks
Treatment-Emergent Adverse Events which will be analysed in study ill be: 1. Adverse Event (AE) 2. Serious Adverse Events (SAE) 3. Adverse Device Effect (ADE) 4. Serious Adverse Device Effect (SADE) Each of the Treatment-Emergent Adverse Events will be assessed for their seriousness, severity [using NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 v. 5.0] and causality (relationship with the use of the investigated medical device).
Column performance effectiveness
Time frame: 16 weeks
Column efficiency and effectiveness in removal of sTNF-Rs from patient plasma without clinically-meaningful leaching of capture ligand (SC-TNF-α) - change in sTNF-R and TNF-α plasma levels from initiation to the end of each LW-02 column perfornance effectiveness will be assessed to measure over 30 minutes (sTNF-Rs) and over the duration (leaching) of each procedure, respectively: * Removal of soluble TNF receptor 1 (sTNF-R1) * Removal of soluble TNF receptor 2 (sTNF-R2) * Leaching of sc-TNF-α from the column
Incidence of Treatment-Emergent Adverse Events of special interest.
Time frame: 16 weeks
Incidence of Treatment-Emergent Adverse Events of special interest assessment will include: 1. tumor lysis syndrome and 2. systemic inflammatory response syndrome. These events may or may not be serious and they may or may not be considered related to study treatment. Regardless of relationship or severity, these events will be recorded if they start after the first application of study treatment and will be followed until resolution.
10 secondary outcomes
Patient functioninig with Eastern Cooperative Oncology Group (ECOG)
Time frame: 16 weeks
Quality of life assessment with EQ-5D-5L scale
Time frame: 16 weeks
Quality of life assessment with EORTC-QLQ-C30 scale
Time frame: 16 weeks
Quality of life assessment with EORTC-QLQ-LC29 scale
Time frame: 16 weeks
Clinical endpoint - overall survival
Time frame: 16 weeks
Clinical endpoint - progression free survival
Time frame: 16 weeks
Clinical endpoint - disease control rate
Time frame: 16 weeks
Nutritional status assessment
Time frame: 16 weeks
Physical performance status assessment with 6 minute walk test (6MWT)
Time frame: 16 weeks
Muscle performance assessment with a hand grip test
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Ostrowski, MD Medical Director, International - Immunicom, Inc. contact
Robert Segal, MD FACP Chief Medical Officer - Immunicom, Inc. contact
Adam Ostrowski, MD study director
Immunicom Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LW-02 device immunopheresis combined with atezolizumab, LW-02 device immunopheresis combined with weekly paclitaxel and LW-02 device immunopheresis in people with Non Small Cell Lung Cancer, run by Immunicom Inc at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Ostrowski, MD Medical Director, International - Immunicom, Inc. (+48 606446610, adam.ostrowski@immunicom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 16 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.