UMIN-CTR Clinical Trial

Public title

A randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis

Acronym

Japanese Intergroup Study of Nintedanib for NSCLC with IPF (J-SONIC)

Scientific Title

A randomized phse 3 study of carboplatin plus nab-paclitaxel with or without nintedanib for advanced non-small-cell lung cancer with idiopathic pulmonary fibrosis

Scientific Title:Acronym

Japanese Intergroup Study of Nintedanib for NSCLC with IPF (J-SONIC)

Region

Japan

Condition

Non-small-cell lung cancer with idiopathic pulmonary fibrosis

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of carboplatin plus nab-paclitaxel in combination with nintedanib compared with carboplatin plus nab-paclitaxel in patients with advanced non-small cell lung cancer with idiopathic pulmonary fibrosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

Time to acute exacerbation of IPF (Initiation of 2nd line chemotherapy for non-small cell lung cancer is not treated as censored)

Key secondary outcomes

Time to acute exacerbation of IPF (Initiation of 2nd line chemotherapy for non-small cell lung cancer is treated as censored), Exacerbation-free survival of IPF, Frequency of patients with acute exacerbation of IPF, Rate of decline in FVC (expressed in mL over 12 weeks), Quality of life (QOL), Overall response rate (ORR), Progression-free survival (PFS) of non-small cell lung cancer, Time to treatment failure (TTF), Overall survival (OS), toxicity

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A: 4 cycles of Carboplatin (AUC 6, day 1) plus nab-Paclitaxel (100 mg/m2, day 1, 8, 15) repeated every 3 weeks

Interventions/Control_2

B: 4 cycles of Carboplatin (AUC 6, day 1) plus nab-Paclitaxel (100 mg/m2, day 1, 8, 15) in combination with nintedanib (150 mg B.I.D, daily) repeated every 3 weeks followed by single-agent administration of nintedanib (150 mg B.I.D, daily)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Written informed consent
2) 20 years of age or older
3) Histologically or cytologically proven non-small cell lung carcinoma
4) Clinical stage III, IV or recurrent disease after surgery
5) With or without measurable lesions
6) Without symptomatic central nervous system metastases
7) Without uncontrollable cardiac effusion, pleural effusion, ascites, superior vena cava syndrome or spinal cord compression
8) No prior chemotherapy
9) No history of treatment with nintedanib, nab-paclitaxel or immune checkpoint inhibitor
10) No prior operation under general anesthesia within 14 days before registration
11) No prior palliative radiotherapy within 14 days before registration
12) No prior biopsy under incision, thoracoscopic biopsy, or treatment for wound occurred within 7 days before registration
13) No prior blood transfusion or hematopoietic factor administration within 7 days before registration
14) No history of treatment with pirfenidone, cyclophosphamide, cyclosporine within 56 days before registration
15) No history of systemic treatment with steroid at a daily dose of more than 15mg in prednisolone equivalent.
16) Definite honeycomb lung destruction with basal and peripheral predominance or presence of reticular abnormality and traction bronchiectasis consistent with fibrosis with basal and peripheral predominance.
17) DLCO 36% to 79% predicted of normal
18) FVC >= 50% predicted of normal
19) SpO2 >= 90% or PaO2 >= 60 torr
under room air conditions
20) ECOG performance status of 0 or 1
21) Correspond to the following values in laboratory tests performed within 14 days before registration
a. Neutrophil count >= 1,500 /mm3
b. Hemoglobin >= 9.0 g/dL
c. Platelet count >= 100,000 /mm3
d. Total bilirubin <= 1.5 mg/dL
e. AST <= 100 IU/L
f. ALT <= 100 IU/L
g. Creatinine <= 2.0 mg/dL
h. PT-INR <= 2
i. Proteinuria <= Grade1 (CTCAE ver 4.0)

Key exclusion criteria

1) Ground glass opacity is less extensive than reticular opacity pattern
2) History of acute exacerbation of IPF
3) Other interstitial lung disease of known etiology including infection, pneumoconiosis, drug-induced pneumonitis, sarcoidosis, and collagen vascular disease
4) Synchronous or metachronous active double malignancies
5) With serious complications
6) With high bleeding risks
7) Local or systemic active infection that requires treatment
8) Pregnant, possibly pregnant or breastfeeding, or unwilling to practice contraception during the study
9) Severe psychiatric diseases
10) History of serious drug allergies
11) Other conditions not suitable for this study

Target sample size

240

Name of lead principal investigator

1st name
Middle name
Last name	Isamu Okamoto

Organization

Kyushu University

Division name

Research Institute for Diseases of the Chest

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL

090-642-5378

Email

okamotoi@kokyu.med.kyushu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shinichiro Nakamura

Organization

West Japan Oncology Group

Division name

WJOG datacenter

Zip code

Address

Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka 556-0016 JAPAN

TEL

06-6633-7400

Homepage URL

Email

datacenter@wjog.jp

Institute

Research Institute for Diseases of the Chest, Kyushu University

Institute

Department

Personal name

Organization

Nippon Boehringer Ingelheim Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/35361630/

Number of participants that the trial has enrolled

243

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

03

Month

24

Day

Date of IRB

2017

Year

05

Month

12

Day

Anticipated trial start date

2017

Year

05

Month

12

Day

Last follow-up date

2022

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

03

Month

31

Day

Last modified on

2022

Year

10

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030665