UMIN-CTR Clinical Trial

Basic information
Public title	Additional biomarker study of Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Acronym	Additional biomarker study of Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Scientific Title	Additional biomarker study of Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Scientific Title:Acronym	Additional biomarker study of Randomized Phase III Study of Pemetrexed + Cisplatin and Vinorelbine + Cisplatin for Completely Resected Non-squamous Non-Small Cell Lung Cancer
Region	Japan

Condition
Condition	Completely resected non-squamous non-small cell lung cancer patients (pathologic stage II-IIIA)
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate the prognostic and predictive biomarkers for NSCLC cancer treated with Cisplatin plus Pemetrexed or Vinorelbine
Basic objectives2	Others
Basic objectives -Others	Biomarker study
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Analysis of somatic gene mutation and gene expression in tumor tissue
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically confirmed non-squamous NSCLC. Adenosquamous carcinoma is eligible if the squamous cell carcinoma component is less than 50%. 2) Pathologic stage II or IIIA (UICC TNM Classification 7th edition) 3) Proven EGFR gene mutation status (Exon19 deletion/ Exon21 L858R; present/ absent) (regardless of the type of determination method) 4) Complete resection* is pathologically confirmed. *Complete resection is the surgical procedure which removes lung cancer to the R0 level. However, when cancer metastasis is found in the uppermost part of a dissected or sampled lymph node in R0 (un) cases, the case is defined as "incomplete resection". R1 (is) and R1(cy+) are also defined as "incomplete resection". 5) The level of surgical resection is higher than lobectomy. 6) ND2a-1 or higher-level lymph node dissection or selective lymph node dissection has been conducted. 7) No other treatments except surgery have been carried out for lung cancer. 8) The age is within 20-75 years inclusive. 9) A performance status (ECOG) of 0 or 1. 10) Registration was made at 21 or more days after surgery but within 56 days after surgery. 11) The functions of the main organs are maintained, and all the criteria stated below are satisfied. (Laboratory test values should be the most recent findings obtained within 14 days before registration, although the findings made 2 weeks previously are acceptable, if they were obtained on the same day of the week as that of the date of registration.) * Hemoglobin: >=9.0 g/dl * WBC: >=3000/mm3 (Neutrophil count: >=1500/mm3) * Platelet count: >=100,000/mm3 * Both AST and ALT: <=100 IU/L * Total bilirubin: <=1.5 mg/dl * Serum creatinine: <=1.5 mg/dl * Creatinine clearance: >=60 ml/min (actual measurement or the value obtained using the Cockcroft-Gault formula) 12) PaO2: >=70 Torr or SpO2: >=95% in the state of no oxygen inhalation (room climate) 13) Submission of written informed consent concerning study participation.
Key exclusion criteria	1) Have active double cancer (synchronous double cancer and metachronous double cancer within a 5-year disease-free interval are defined as active double cancer; in situ uterocervical carcinoma judged to be curable by topical therapy, gastric/colorectal cancer resectable by endoscopy, and topically resectable active skin diseases, except malignant melanoma, are not included in active double cancer); however, a patient is eligible even if double primary NSCLC is observed in the resected lung. 2) Previously treated with cisplatin, pemetrexed or vinorelbine 3) Administration of folic acid or Vitamin B12 is not possible. 4) Serious post-operative complications (post-operative infections, suture failures, etc.) 5) Interstitial shadow considered to be clearly indicative of interstitial pneumonia on chest CT 6) Active infection 7) Requirement of continuous systemic administration (oral or intravenous) of steroid at a dose > 10 mg/day in the case of prednisolone, and the current use of an immunosuppressant; however, patients currently treated with oral steroid at a dose of 10 mg/day in case of prednisolone can be enrolled in the study. 8) Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period and lactating women. Men who will not be compliant with a contraceptive regimen during and for 6 months after the treatment period. 9) History of serious drug hypersensitivity 10) Other serious complications 11) Others judged by the investigator to be unsuitable for the study
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuto Nishio
Organization	Kinki University Faculty of Medicine
Division name	Department of Genome Biology
Zip code
Address	377-2 Ohno-Higashi, Osaka-sayama, Osaka, 589-8511, Japan
TEL	072-366-0221
Email	knishio@med.kindai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuko Sakai
Organization	Kinki University Faculty of Medicine
Division name	Department of Genome Biology
Zip code
Address	377-2 Ohno-Higashi, Osaka-sayama, Osaka, 589-8511, Japan
TEL	072-366-0221
Homepage URL
Email	kasakai@med.kindai.ac.jp

Sponsor
Institute	Kinki University Faculty of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	TCOG, TORG, CJLSG, West Japan Oncology Group, JMTO, Setouchi Lung Cancer Study Group, LOGIK.
Name of secondary funder(s)	Kinki University Faculty of Medicine, Department of Genome Biology

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	2013 Year 11 Month 08 Day

Related information
URL releasing protocol	None
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/10.1111/cas.14730
Number of participants that the trial has enrolled	389
Results	The study demonstrated the significance of tumor mutation burden as a biomarker for predicting the recurrence-free survival of pemetrexed/cisplatin in stage II-IIIA non-squamous non-small cell lung cancer patients.
Results date posted	2021 Year 11 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	not applicable
Participant flow	not applicable
Adverse events	not applicable
Outcome measures	not applicable
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 30 Day
Date of IRB	2013 Year 11 Month 02 Day
Anticipated trial start date	2013 Year 11 Month 08 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Nothing in particular

Management information
Registered date	2013 Year 11 Month 07 Day
Last modified on	2022 Year 01 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014309