UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044375 |
|---|---|
| Receipt number | R000050571 |
| Scientific Title | AN OBSERVATIONAL STUDY OF EFFECTIVENESS AND SAFETY OF THE FIRST LINE NIVOLUMAB PLUS IPILIMUMAB WITH OR WITHOUT CHEMOTHERAPY FOR ADVANCED / RECURRENT NON-SMALL CELL LUNG CANCER IN JAPAN (LIGHT-NING) |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2023/12/13 10:54:37 |
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Basic information
Public title
AN OBSERVATIONAL STUDY OF EFFECTIVENESS AND SAFETY OF THE FIRST LINE NIVOLUMAB PLUS IPILIMUMAB WITH OR WITHOUT CHEMOTHERAPY FOR ADVANCED / RECURRENT NON-SMALL CELL LUNG CANCER IN JAPAN (LIGHT-NING)
Acronym
LIGHT-NING
Scientific Title
AN OBSERVATIONAL STUDY OF EFFECTIVENESS AND SAFETY OF THE FIRST LINE NIVOLUMAB PLUS IPILIMUMAB WITH OR WITHOUT CHEMOTHERAPY FOR ADVANCED / RECURRENT NON-SMALL CELL LUNG CANCER IN JAPAN (LIGHT-NING)
Scientific Title:Acronym
LIGHT-NING
Region
| Japan |
Condition
Condition
ADVANCED / RECURRENT NON-SMALL CELL LUNG CANCER
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For nivolumab plus ipilimumab with or without chemotherapy as first-line treatment for patients with untreated advanced or recurrent NSCLC in the real-world setting in Japan, the actual treatment status will be clarified and the effectiveness and safety will be described.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Actual treatment
-Descriptions of administration (duration of treatment, rates of patients with second-line treatment, etc.)
-Effectiveness (overall survival, time to next treatment, treatment-free survival, and treatment continuation rate)
-Safety (incidence of CTCAE v 5.0 Grade 3 or higher immune-related adverse events and incidence of treatment-related adverse events leading to treatment discontinuation)
Key secondary outcomes
1. Effectiveness in patients evaluated for response in accordance with RECIST v 1.1 (progression-free survival, objective response rate, disease control rate, and duration of response)
2. Effectiveness and safety by patient background
3. Effectiveness and safety of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
4. Time to onset of immune-related adverse events to be collected, treatment for these events and time to symptom improvement, and impact on effectiveness
5. Descriptions of administration (duration of treatment, reasons for treatment discontinuation, etc.), effectiveness (response rate) and safety (treatment related death) of second-line treatment
6. Effectiveness in patients who discontinued treatment due to treatment-related adverse events within 90 days
7. Descriptions of administration (duration of treatment, reasons for treatment discontinuation, etc.), effectiveness (response rate and overall survival) and safety (treatment related death) of second-line treatment in patients with disease progression within 90 days
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For entry into this study, the following criteria MUST be met at the time of informed consent:
1. Patients aged over 20 years
2. Histologically confirmed advanced or recurrent NSCLC
3. Patients who have received or scheduled to administrate nivolumab plus ipilimumab with or without chemotherapy as first-line treatment from the date of approval of nivolumab plus ipilimumab with or without chemotherapy to December 31, 2021.
a) Pemetrexed plus cisplatin or carboplatin for patients with non-squamous histology and paclitaxel plus carboplatin for patients with squamous histology are only acceptable combinations of chemotherapy.
4. Patients who have signed written informed consent form with their own free will after they have been given an adequate explanation and a fully understanding of this study
a) Patients who have difficulty in writing may be registered in this study by writing on their behalf by a person equivalent to a legally acceptable representative, with the patient's oral consent.
b) In patients for whom it is difficult to obtain informed consent, the patient's legally acceptable representative may be registered if informed consent is obtained after explanation to the legally acceptable representative.
c) If it is difficult to obtain informed consent from the patient or legally acceptable representative for various reasons other than a) and b), registration is allowed by opt-out.
Key exclusion criteria
For entry into the study, the following criteria MUST NOT be met at the time of informed consent:
1. In patients with non-squamous histology, patients who are confirmed to be positive for EGFR gene mutation or ALK fusion gene for which EGFR tyrosine kinase inhibitor or ALK tyrosine kinase inhibitor is indicated.
2. Patients who had antineoplastic treatment as first-line treatment of advanced or recurrent NSCLC prior to initiation of nivolumab plus ipilimumab with or without chemotherapy.
However, patients who correspond to a) or b) below will be included in this study.
a) Prior perioperative chemotherapy or Stage III chemoradiotherapy or durvalumab combination chemoradiotherapy.
b) Patients who are received or have received bisphosphonates or denosumab for bone metastasis
3. Patients who initiated treatment with nivolumab plus ipilimumab and added chemotherapy from the second course onwards.
4. Patients who received investigational anti-tumor drug in clinical trial after being diagnosed with NSCLC
5. Other patients who are judged by the investigators to be inappropriate for enrollment in this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Ohsugi |
Organization
Bristol-Myers Squibb K.K.
Division name
Oncology Medical, Japan Medical
Zip code
1000004
Address
Otemachi One Tower 1-2-1 Otemachi Chiyoda-ku Tokyo 100-0004, Japan
TEL
0367057000
Tomoyuki.Ohsugi@bms.com
Public contact
Name of contact person
| 1st name | hayato |
| Middle name | |
| Last name | konishi |
Organization
Mebix, Inc
Division name
Research Promotion Headquarters
Zip code
5410046
Address
Aioi Nissay Dowa Sonnpo midosuji Building floor 9, 3-6-1, Hiranomachi, Chuo-ku, Osaka-fu, Osaka
TEL
03-4362-4500
Homepage URL
LIGHT-NING@mebix.co.jp
Sponsor or person
Institute
Bristol-Myers Squibb K.K.
Ono Pharmaceutical CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers Squibb K.K.
Ono Pharmaceutical 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
Ono Pharmaceutical CO.,LTD. "Medical and Health Research Involving Human Subjects" Ethics Committee
Address
8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi, Japan
Tel
06-6263-2992
n.nishiwaki@ono.co.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
529
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is designed as a descriptive epidemiological study.
Management information
Registered date
| 2021 | Year | 05 | Month | 31 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050571
