UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030782
Receipt number R000035143
Scientific Title Phase II study for efficacy and safety of pembrolizumab for the cytotoxic chemotherapy unfit previously untreated or treated PD-L1 positive advanced non-small cell lung cancer
Date of disclosure of the study information 2018/01/12
Last modified on 2019/03/22 12:13:29

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Basic information

Public title

Phase II study for efficacy and safety of pembrolizumab for the cytotoxic chemotherapy unfit previously untreated or treated PD-L1 positive advanced non-small cell lung cancer

Acronym

Phase II study of pembrolizumab for advanced NSCLC patients with poor PS

Scientific Title

Phase II study for efficacy and safety of pembrolizumab for the cytotoxic chemotherapy unfit previously untreated or treated PD-L1 positive advanced non-small cell lung cancer

Scientific Title:Acronym

Phase II study of pembrolizumab for advanced NSCLC patients with poor PS

Region

Japan


Condition

Condition

PD-L1 positive previously treated advanced non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To explore the efficacy and safety of nivolumab for PD-L1 positive previously untreated or treated advanced lung cancer patients who have no indication for standard chemotherapy, including cytotoxic chemotherapy and molecular targeted therapy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Progression-free survival, Overall survival, and Toxicity.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Pembrolizumab 200mg (day 1, q3 weeks) until clinical progression or unacceptable toxicities for two years.

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) Definitively diagnosed with having PD-L1 positive previously untreated or treated advanced non-small cell lung cancer by the specimens histologically or cytologically who have no indication for standard treatment of chemotherapy including cytotoxic chemotherapy and molecular targeted agents for driver mutation.
2) Age of 20 years and older
3) With adequate organ function of bone marrow reserve, liver, and kidney.
(1) PS 2-4
(2) neutrophil count => 500/mm^3
(3) platelet => 50,000/mm^3
(4) hemoglobin => 6.5g/dL
(5) AST/ALT < 5 times less than ULN
(6) T.Bil <= 3.0mg/dL
(7) serum creatinine <= 3.0mg/dL
(8) ECG: without clinically problematic abnormalities
(9) SpO2 more than 92% (O2 < 2L/min)
4) With the status of below previous treatment at the time of beginning of chemotherapy.
(1) Radiotherapy: irradiated extrathoracic lesion: more than two weeks from the date of last irradiation
(2) Surgical procedure, including pleurodesis or pleural drainage
* more than 8 weeks with lobectomy
* more than 4 weeks without lobectomy, including exploratory thoracotomy
* more than 2 weeks after completing procedure (pleurodesis or pleural drainage)
5) With written informed consent

Key exclusion criteria

1) The age of less than 20
2) Indicative for cytotoxic chemotherapy or molecular targeted agents
3) Uncontrolled brain metastasis treated by palliative radiotherapy
4) Clinically active infection
5) Severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes)
6) Uncontrolled pleural effusion
7) Active other organ cancers
8) History of severe drug allergy
9) Uncontrolled digestive ulcer
10) Any patients judged by the investigator to be unfit to participate in the study

Target sample size

32


Research contact person

Name of lead principal investigator

1st name Yukio
Middle name
Last name Hosomi

Organization

Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital

Division name

epartment of Respiratory Medicine and Thoracic Oncology

Zip code

113-8677

Address

3-18-22, Honkomagome, Bunkyo, Tokyo

TEL

03-3823-2101

Email

yhosomi@cick.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Okuma

Organization

Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital

Division name

Department of Respiratory Medicine and Thoracic Oncology

Zip code

113-8677

Address

3-18-22, Honkomagome, Bunkyo, Tokyo

TEL

03-3823-2101

Homepage URL


Email

y-okuma@cick.jp


Sponsor or person

Institute

Department of Respiratory Medicine and Thoracic Oncology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Respiratory Medicine and Thoracic Oncology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committee of Tokyo Metropolitan Komagome Hospital

Address

3-28-22, Honkomagome, Bunkyo, Tokyo

Tel

03-3823-2101

Email

rinri@cick.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

がん・感染症センター都立駒込病院


Other administrative information

Date of disclosure of the study information

2018 Year 01 Month 12 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

Enrolling by invitation

Date of protocol fixation

2017 Year 05 Month 01 Day

Date of IRB

2017 Year 05 Month 01 Day

Anticipated trial start date

2018 Year 01 Month 11 Day

Last follow-up date

2022 Year 02 Month 28 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 12 Day

Last modified on

2019 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035143


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name