Unique ID issued by UMIN | UMIN000030994 |
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Receipt number | R000034884 |
Scientific Title | Efficacy and safety of nanoparticle albumin-bound paclitaxel after immune checkpoint inhibitor therapy in patients with advanced non-small cell lung cancer: a phase II trial |
Date of disclosure of the study information | 2018/01/29 |
Last modified on | 2023/07/25 20:03:14 |
Efficacy and safety of nanoparticle albumin-bound paclitaxel after immune checkpoint inhibitor therapy in patients with advanced non-small cell lung cancer: a phase II trial
Phase II trial of nab-paclitaxel after immune checkpoint inhibitor therapy in patients with advanced non-small cell lung cancer
Efficacy and safety of nanoparticle albumin-bound paclitaxel after immune checkpoint inhibitor therapy in patients with advanced non-small cell lung cancer: a phase II trial
Phase II trial of nab-paclitaxel after immune checkpoint inhibitor therapy in patients with advanced non-small cell lung cancer
Japan |
Advenced non-small cell lung cancer immediately after immune checkpoint inhibitors failure
Pneumology | Hematology and clinical oncology |
Malignancy
NO
Efficacy and safety of nab-paclitaxel monotherapy in patients with non-small cell lung cancer immidiately after immune checkpoint inhibitors therapy.
Safety,Efficacy
Objective response rate.
Progression-free survival, disease control rate, overall survival, and saftey.
Subset analysis of efficacy stratified by histological subtype, presense of driver mutations (EGFR/ALK/ROS1), smoking history, and degree of tumor PD-L1 expression.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Chemotherapy
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients with non-small cell lung cancer within 12 weeks after immune checkpoint inhibitors therapy (including anti PD-1 antibody, anti PD-L1 antibody, and immune checkpoint inhibitors combination with cytotoxic agents).
2) Patient with evaluable lesion based on RECIST.
3) Age 20 or over.
4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5) No severe organ dysfunction and laboratory data fulfill the standards.
6) Three months and more survival is expected.
7) Written informed consent.
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.
5) Thoracic radiotherapy after initiation of immune checkpoint inhibitors, and within 2 weeks after radiotherapy for lesions except primary lesion.
6) Operation within 4 weeks.
7) Active double cancer.
8) High body temperature (38 degrees Celsius and more).
9) Severe complications including heart failure, hepatic failure, and renal failure.
10) Pregnant woman.
11) HBs antigen positive.
12) The subjects whom the doctor excluded.
30
1st name | Yukihiro |
Middle name | |
Last name | Umeda |
University of Fukui
Third department of internal medicine
9101193
23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
0776-61-3111
umeda@u-fukui.ac.jp
1st name | Yukihiro |
Middle name | |
Last name | Umeda |
University of Fukui
Third department of internal medicine
9101193
23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
0776-61-3111
umeda@u-fukui.ac.jp
Third department of internal medicine, Universtiy of Fukui
None
Self funding
Japanese Red Cross Fukui Hospital
The Research Ethics Committee of University of Fukui
23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
+81776613111
smsien-k@ad.u-fukui.ac.jp
NO
2018 | Year | 01 | Month | 29 | Day |
https://onlinelibrary.wiley.com/doi/10.1002/cam4.5978
Unpublished
https://onlinelibrary.wiley.com/doi/10.1002/cam4.5978
30
Thirty cases were registered, and 29 cases were included in the analysis. The ORR was 55.2percent and the DCR was 86.2percent. The median PFS was 5.6 months, and PFS rates at 1-year and 2-year timepoints were 34.5percent and 13.3percent, respectively. The median OS was 11.9 months.
2023 | Year | 07 | Month | 25 | Day |
Seventy precent subjects were males, and the ages of the subjects ranged from 43 to 82 years. ECOGPS, histology, and PDL1 status were as follows, 9 patients with PS 0, 19 patients with PS 1, 1 patient with PS 2, 11 patients with squamous cell carcinoma, 14 patients with adenocarcinoma, 4 patients with NSCLC, not otherwise specified, 13 patients with PDL1 less than 1precent, 5 patients with PDL1 1,49precent, 9 patients with PDL1 more than 50precent, and 2 patients with unknown PDL1 status. Past treatment history was 1 regimen in 6 patients, 2 regimens in 17 patients, and 3 or more regimens in 6 patients.
Between February 2018 and December 2020, 30 patients with advanced NSCLC were recruited, and 29 patients were included in the analysis. The protocol-defined final analysis was performed on December 11, 2021.
Grade 3 or higher hematologic toxicity included leukopenia (27.6%) and neutropenia (31.0%); however, no patients with febrile neutropenia were observed. Nonhematologic toxicities observed in more than 40% of patients were peripheral sensory neuropathy (41.4%) and alopecia (58.6%), whereas grade 3 or higher adverse events were 6.9% and 0.0%, respectively. Interstitial lung disease (ILD) was observed in three patients (10.3%), of which one (3.4%) had grade 3. There were no treatment-related deaths.
Of the 29 assessable patients, 1 (3.4percent) achieved complete response (CR), 15 (51.7percent) had partial response (PR), 9 (31.0percent) had stable disease (SD), and 4 (13.8percent) experienced PD. The ORR was 55.2percent (95percent CI 28.1,79.6percent) and the DCR was 86.2percent (95percent CI 65.9,97.0percent), suggesting high efficacy.
Completed
2018 | Year | 01 | Month | 22 | Day |
2018 | Year | 01 | Month | 22 | Day |
2018 | Year | 01 | Month | 29 | Day |
2021 | Year | 12 | Month | 11 | Day |
2018 | Year | 01 | Month | 25 | Day |
2023 | Year | 07 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034884
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