UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055099 |
|---|---|
| Receipt number | R000062944 |
| Scientific Title | Efficacy and safety of nanoparticle albumin-bound paclitaxel plus bevacizumab after first-line platinum-based chemotherapy with immune checkpoint inhibitor therapy in patients with advanced non-squamous non-small cell lung cancer: a phase II trial |
| Date of disclosure of the study information | 2024/07/29 |
| Last modified on | 2024/10/18 14:48:48 |
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Basic information
Public title
Efficacy and safety of nanoparticle albumin-bound paclitaxel plus bevacizumab after first-line platinum-based chemotherapy with immune checkpoint inhibitor therapy in patients with advanced non-squamous non-small cell lung cancer: a phase II trial
Acronym
Efficacy and safety of nanoparticle albumin-bound paclitaxel plus bevacizumab after first-line platinum-based chemotherapy with immune checkpoint inhibitor therapy in patients with advanced non-squamous non-small cell lung cancer: a phase II trial
Scientific Title
Efficacy and safety of nanoparticle albumin-bound paclitaxel plus bevacizumab after first-line platinum-based chemotherapy with immune checkpoint inhibitor therapy in patients with advanced non-squamous non-small cell lung cancer: a phase II trial
Scientific Title:Acronym
Efficacy and safety of nanoparticle albumin-bound paclitaxel plus bevacizumab after first-line platinum-based chemotherapy with immune checkpoint inhibitor therapy in patients with advanced non-squamous non-small cell lung cancer: a phase II trial
Region
| Japan |
Condition
Condition
Advenced non-squamous, non-small cell lung cancer immediately after platinum-based chemotherapy with immune checkpoint inhibitors failure
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and safety of nab-paclitaxel plus bevacizumab in patients with advenced non-squamous, non-small cell lung cancer immediately after platinum-based chemotherapy with immune checkpoint inhibitors failure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective response rate
Key secondary outcomes
Progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and saftey.
Subset analysis of efficacy (ORR, DCR, PFS, and OS) stratified by presense of driver mutations (EGFR, ALK, ROS1, BRAF V600E, KRAS G12C, HER2, METex14skipping, NTRK), smoking history,degree of tumor PD-L1 expression, tumor TTF-1 expression, and tumor response and duration of response of previous treatment.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Chemotherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with advanced or recurrent non-small cell lung cancer excluding squamous cell carcinoma confirmed by histological or cytological diagnosis.
2) Patients within 12 weeks of completion of platinum-based chemotherapy plus ICI (PD-1,PD-L1, or CTLA-4 antibody) or its maintenance therapy, regardless of previous use of molecularly targeted agents or VEGF inhibitors such as bevacizumab or ramucirumab, or the number of prior regimens. Reasons for discontinuation of prior therapy for progression, relapse, or adverse events are allowed.
3) Patient with evaluable lesion based on RECIST.
4) Age 18 or over.
5) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
6) No severe organ dysfunction and laboratory tests meet the following criteria.
(a) White blood cell count greater than 3,000/mm3
(b) Neutrophil count greater than 1,500/mm3
(c) Hemoglobin greater than 9.0 g/dL
(d) Platelet count greater than 100,000/mm3
(e) AST, ALT less than 100 IU/L
(f) Total bilirubin less than 1.5 mg/dL
(g) Creatinine less than 1.5 mg/dL
(h) Urine protein: 1+ or less
(i) PT-INR: 1.5 or less
(j) PaO2 60 torr or higher or SpO2 90% or higher (room air)
7) Three months and more survival is expected.
8) Written informed consent.
Key exclusion criteria
1) Allergy or hypersensitibity against the medicines in this trial or albumin.
2) Patients who previously treated with paclitaxel or nab-paclitaxel.
3) Peripheral neuropathy (grade 2 or more) before the treatment.
4) Uncontrolable pleural or pericardial effusion, or ascites.
5) Patients undergoing radiotherapy, or within 2 weeks after thoracic or brain radiotherapy completion and within 1 week after radiotherapy for bone metastasis.
6) Operation within 4 weeks.
7) Active double cancer.
8) High body temperature (38 degrees Celsius and more).
9) Severe complications including gastrointestinal bleeding, perforation of the gastrointestinal tract, fistulae, diverticulitis, intestinal paralysis, intestinal obstruction, superior vena cava syndrome, uncontrolled thromboembolism or hypertension, gastrointestinal ulcers, interstitial pneumonia or pulmonary fibrosis evident on chest X-ray, heart failure, hepatic failure, and renal failure.
10) Pregnant and breastfeeding woman.
11) HBs antigen positive.
12) Patients receiving systemic administration of more than 10 mg of prednisolone equivalent of corticosteroids at the time of enrollment.
13) Patients with untreated brain metastases or cerebral hemorrhage on CT or MRI within 2 months prior to enrollment.
14) Patients with hemoptysis (2.5 mL or more of fresh blood) within 2 months prior to enrollment.
15) Patients with major blood vessels tumor invasion or intratumour cavitation, or tumor exposure into the lumen of the central airway above the regional bronchus on CT.
16) The subjects whom the doctor excluded.
17) Patients taking anticoagulants (warfarin, dabigatran, edoxaban, rivaroxaban, apixaban) or antiplatelet agents (aspirin, clopidogrel, prasugrel, ticlopidine, cilostazol).
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Respiratory Medicine
Zip code
910-1193
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji, Fukui
TEL
0776-61-3111
umeda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Respiratory Medicine
Zip code
9101193
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji, Fukui
TEL
0776-61-3111
Homepage URL
umeda@u-fukui.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Yukihiro Umeda
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Red Cross Fukui Hospital, Municipal Tsuruga Hospital, and Toyama Prefectural Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of University of Fukui
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji, Fukui
Tel
0776-61-3111
rinsho-rinri@ml.u-fukui.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
福井赤十字病院（福井県）、市立敦賀病院（福井県）、富山県立中央病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062944
