UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030994
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

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Basic information

Public 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

Acronym

Phase II trial of nab-paclitaxel after immune checkpoint inhibitor therapy in patients with advanced non-small cell lung cancer

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

Scientific Title:Acronym

Phase II trial of nab-paclitaxel after immune checkpoint inhibitor therapy in patients with advanced non-small cell lung cancer

Region

Japan


Condition

Condition

Advenced non-small cell lung cancer immediately after immune checkpoint inhibitors failure

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Efficacy and safety of nab-paclitaxel monotherapy in patients with non-small cell lung cancer immidiately after immune checkpoint inhibitors therapy.

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, 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.


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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.

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.
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.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yukihiro
Middle name
Last name Umeda

Organization

University of Fukui

Division name

Third department of internal medicine

Zip code

9101193

Address

23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan

TEL

0776-61-3111

Email

umeda@u-fukui.ac.jp


Public contact

Name of contact person

1st name Yukihiro
Middle name
Last name Umeda

Organization

University of Fukui

Division name

Third department of internal medicine

Zip code

9101193

Address

23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan

TEL

0776-61-3111

Homepage URL


Email

umeda@u-fukui.ac.jp


Sponsor or person

Institute

Third department of internal medicine, Universtiy of Fukui

Institute

Department

Personal name



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

Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Research Ethics Committee of University of Fukui

Address

23-3, Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan

Tel

+81776613111

Email

smsien-k@ad.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



Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 29 Day


Related information

URL releasing protocol

https://onlinelibrary.wiley.com/doi/10.1002/cam4.5978

Publication of results

Unpublished


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1002/cam4.5978

Number of participants that the trial has enrolled

30

Results

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.

Results date posted

2023 Year 07 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

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.

Participant flow

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.

Adverse events

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.

Outcome measures

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.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 01 Month 22 Day

Date of IRB

2018 Year 01 Month 22 Day

Anticipated trial start date

2018 Year 01 Month 29 Day

Last follow-up date

2021 Year 12 Month 11 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 25 Day

Last modified on

2023 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034884


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name