UMIN-CTR Clinical Trial

Basic information
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
Condition	Non-small-cell lung cancer with idiopathic pulmonary fibrosis
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Research Institute for Diseases of the Chest, Kyushu University
Institute
Department

Funding Source
Organization	Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
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

Progress
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
Other related information

Management information
Registered date	2017 Year 03 Month 31 Day
Last modified on	2022 Year 10 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030665