UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015662
Receipt number R000018059
Scientific Title Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis
Date of disclosure of the study information 2014/11/12
Last modified on 2022/05/03 23:52:50

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Basic information

Public title

Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis

Acronym

Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis

Scientific Title

Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis

Scientific Title:Acronym

Phase II Study of Carboplatin+nab-Paclitaxel for Non-small Cell Lung Cancer with Interstitial Pneumonitis

Region

Japan


Condition

Condition

Advanced Non-small Cell Lung Cancer with Interstitial Pnumonitis

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the safety and efficacy of carboplatin plus nab-paclitaxel in patients with advanced non-small-cell lung cancer with interstitial pneumonitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Treatment completion rate (>=4cycles)

Key secondary outcomes

Overrall response rate(ORR), Disease control rate(DCR), Progression free survival(PFS), Overall survival (OS), Safety (frequency of of acute exacerbation of interstitial pneumonitis, frequency of the other adverse effects)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Four to six cycles of Carboplatin day1(AUC5) plus Nab-Paclitaxel day1,8,15 (100mg/m2) every 4 weeks .

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Histologically or cytologically confirmed non-small cell lung cancer (if mixed type, judged by major histology)
2)Clinical stageIIIA, IIIB not amenable to curative treatment or stage IV, or post operative reccurence (TNM classification, 7th edition)
3) Eligible with or without EGFR mutation , Eligible with or without ALK translocation
4) Interstitial pneumonitis confirmed by high resolution chest CT (less than 2.5mm slice)
eligible pirfenidone or inhalation of NAC without the activity of interstitial pnumonitis
eligible secondary interstitial pnumonitis except IIP
fill at least 2 of the following radiological findings and eligible judged by central review; honeycoming, traction ectasia, ground-grass opacity, interlobular septal thickening
5) Patients aged 20-79
6) ECOG PS 0-1
7) Patients are excepted to live at least 12 weeks
8) Eligible with or without measurable lesions
9) No prior chemotherapy (eligible; In case of postoperative recurrence, 8 weeks or more than 8 weeks after operation. If performed adjuvant chemotherapy, equal or more than 6 months after the day of the final adjuvant chemotherapy)
10) Adequate organ function, evaluated within 14 days before enrollment
WBC >=3,000/mm3
Neu >=1,500/mm3
Plt >=100,000/mm3
Hb>=9.0g/dl
AST<=2.5XULN, /ALT<=2.5XULN
T.Bil<=1.5mg/dl
sCr<=1.5mg/dl
PaO2>= 70torr
11) less than Grade 2 peripheral neuropathy
12) Written informed consent from the patients
13) No prior radiation therapy for primary cancer (eligible palliative radiation therapy except primary lesion which has done more than 2 weeks before.

Key exclusion criteria

1) Active double cancer
2) Being suspected acute or sub-acute exacerbation of interstitial pneumonitis. Being experienced acute exacerbation of idiopathic interstitial pneumonia.
3) Receiving steroids or immunosuppressants within 3 month for interstitial pneumonia
4) Patiens has pleural effusion, pericardial effusion and ascites to need dranage
5) Serious complications as follows;
History of uncontrollable angina pectoris, acute myocardial infarction or heart faliure, etc within 6 months
History of cerebral infarction within 6 months
Uncontrollable diabetes mellitus, hypertension and diarrhea
Active infectious disease or suspected active infectious disease
Other Serious complications
(ileus, bleeding tendency , SVC syn. Varicella etc)
6) symptomatic brain metastasis
7) Pregnancy, breast feeding and suspected or wish of pregnancy. Men and women who declined contraception
8) Patients who have serious drug hypersensitivity reaction
9) Patients who have received a radiation therapy in chest
10) Having a schedule of operations
11) Patients whose participation in the trial is judged to be inappropriate because of psychiatric disease or psychiatric symptoms
12) Positive HBs antigen
13) Patients whose participation in the trial is judged to be inappropriate by the investigators

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Miyazaki Yasunari

Organization

Tokyo Medical and Dental university

Division name

Department of Integrated Pulmonology

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5954

Email

ninase@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Sakashita

Organization

Tokyo Medical and Dental university

Division name

Department of Integrated Pulmonology (Clinical Oncology)

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-5954

Homepage URL


Email

hsakashita.pulm@tmd.ac.jp


Sponsor or person

Institute

Yushima Lung Cancer Oncology Group(YLOG)

Institute

Department

Personal name



Funding Source

Organization

Department of Integrated Pulmonology, Tokyo Medical and Dental university

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 11 Month 12 Day


Related information

URL releasing protocol

https://onlinelibrary.wiley.com/doi/10.1111/1759-7714.14376

Publication of results

Published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1111/1759-7714.14376

Number of participants that the trial has enrolled

25

Results

The 4-week modified regimen of carboplatin and nab-paclitaxel showed tolerable toxicity with favorable efficacy in NSCLC patients with ILD. This regimen may be an effective treatment option for patients in real clinical settings.

Results date posted

2022 Year 05 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The median age was 71 years, and 23 patients were male. Fifteen patients had PS 0 (60%), and the rest were PS 1 (40%). Adenocarcinoma, Sq, and large cell carcinoma were observed in nine (36%), 11 (44%), and one (4%) patient, respectively, and the others were categorized as not otherwise specified. Nine patients (36%) were EGFR mutation negative, and the rest of patients were unknown. Seven patients (28%) were ALK rearrangement negative, and the rest of patients were unknown. Two patients (16%) were never smokers. Among the imaging findings for ILD on HRCT, honeycombing, traction bronchiectasis, interlobular septal thickening, and ground grass opacity were observed in 12 (48%), 23 (92%), 21 (84%), and 21 (84%) patients, respectively. Two patients were diagnosed with RA, manifesting as RA-related ILD at enrollment. Two other patients showed anticyclic citrullinated peptide (CCP) antibody positivity without symptoms of RA at the time of enrollment, but one of them was later diagnosed with RA and RA lung. The other patients were considered idiopathic. The positive incidence rate and median serum level of KL-6 were 84% and 747 U/ml, respectively.

Participant flow

Nineteen patients (76%) received four or more cycles of the protocol treatment.

Adverse events

The most common hematological grade 3 or 4 adverse event was neutropenia (48%), while febrile neutropenia was not observed. The most common nonhematological adverse events were fatigue (76%), followed by appetite loss (60%). Peripheral neuropathy was observed in 10 patients (40%) without grade 3 or 4 neuropathy. Three patients experienced 2 or more than grade 2 pneumonitis, and one patient met the acute exacerbation criteria.

Outcome measures

Of the 25 patients enrolled in our study, one patient (4%) achieved CR, 10 patients (40%) showed PR, and 11 patients (44%) had SD. Only one patient showed progressive disease (PD), and two patients had a disease status that could not be evaluated. Thus, the ORR and DCR were 44% and 88% respectively. The unconfirmed ORR response rate was 64%. The median PFS and OS were 5.8 months and 15.8 months, respectively.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 07 Month 20 Day

Date of IRB

2014 Year 09 Month 26 Day

Anticipated trial start date

2014 Year 11 Month 12 Day

Last follow-up date

2021 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

2014 Year 11 Month 11 Day

Last modified on

2022 Year 05 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018059


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name