Non-Small Cell Lung CancerLIGHT-NINGNCT05161325
A 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
An observational study of Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in Japan.
Trial summary
The purpose of this observational study is to assess the effectiveness and safety of Nivolumab plus Ipilimumab with or without chemotherapy as first-line treatment for participants with untreated advanced or recurrent NSCLC in the real world setting in Japan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 525 participants
- Where
- 1 siteJapan
- Study dates
- 15 Dec 2020to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a descriptive study of participants who received nivolumab plus ipilimumab with or without chemotherapy within 1 year of approval. In this study, the target sample size is set at 500 participants based on the feasibility to investigate the actual clinical practice.
Who may be able to join
- Histologically confirmed advanced or recurrent NSCLC
- Participants 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 November 30, 2021.
- Pemetrexed plus cisplatin or carboplatin for participants with non- squamous histology and paclitaxel plus carboplatin for participants with squamous histology are only acceptable combinations of chemotherapy.
Who cannot join
- In participants with non-squamous histology, participants 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.
- Participants 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, participants who correspond to a) or b) below will be included in this study.
- Prior perioperative chemotherapy or Stage III chemoradiotherapy or durvalumab combination chemoradiotherapy.
- Participants who are received or have received bisphosphonates or denosumab for bone metastasis
- Participants who initiated treatment with nivolumab plus ipilimumab and added chemotherapy from the second course onwards.
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- Participants who received investigational anti-tumor drug in clinical trial after being diagnosed with NSCLC
- Other participants who are judged by the investigators to be inappropriate for enrollment in this study
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The purpose of this observational study is to assess the effectiveness and safety of Nivolumab plus Ipilimumab with or without chemotherapy as first-line treatment for participants with untreated advanced or recurrent NSCLC in the real world setting in Japan.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- BMS-936558, ONO-4538, Nivolumab, Ipilimumab, Retrospective, Observational
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with untreated advanced or recurrent non-small cell lung cancer (NSCLC) receiving first-line nivolumab plus ipilimumab with or without chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of treatment
Time from the initiation date of nivolumab plus ipilimumab with or without chemotherapy among eligible participants to the last date of treatment as an event.
Measured: Up to 1 year
Rates of participants with second-line treatment
The rate of eligible participants who have completed nivolumab plus ipilimumab with or without chemotherapy during the observation period and have initiated second-line treatment
Measured: Up to 1 year
Overall survival (OS)
Defined as the time between the date of initiation of nivolumab plus ipilimumab with or without chemotherapy and the date of death from any cause among eligible participants.
Measured: Up to 1 year
Incidence of Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 Grade 3 or higher immune-related adverse events [irAEs]
Measured: Up to 1 year
Time to next treatment [(TNT)
Defined as the time between the date of combination therapy with nivolumab plus ipilimumab with or without chemotherapy initiation among eligible participants and the date of second-line treatment initiation or the date of death from any cause, whichever occurs first.
Measured: Up to 1 year
Treatment-free survival (TFS)
Defined as the time between the date of nivolumab plus ipilimumab with or without chemotherapy cessation among eligible participants and the date of second-line treatment initiation or the date of death from any cause, whichever occurs first.
Measured: Up to 1 year
Treatment continuation rate
The rate of eligible participants who have continued nivolumab plus ipilimumab with or without chemotherapy during the observation period.
Measured: Up to 1 year
Incidence of treatment-related adverse events (TRAEs) leading to treatment discontinuation
Measured: Up to 1 year
Secondary outcomes (30)
Progression-free survival (PFS) in participants assessed for tumor response according to RECIST v 1.1
Measured: Up to 1 year
Objective response rate (ORR) in participants evaluated for tumor response according to RECIST v 1.1
Measured: Up to 1 year
Disease control rate (DCR) in participants evaluated for response in accordance with RECIST v 1.1
Measured: Up to 1 year
Duration of response (DOR) in participants evaluated for tumor response in accordance with RECIST v 1.1
Measured: Up to 1 year
Overall Survival (OS) by patient background
Measured: Up to 1 year
Time to next treatment (TNT) by patient background
Measured: Up to 1 year
Treatment-free survival (TFS) by patient background
Measured: Up to 1 year
Treatment continuation rate by patient background
Measured: Up to 1 year
Incidence of CTCAE v 5.0 Grade 3 or higher irAEs by patient background
Measured: Up to 1 year
Incidence of TRAEs leading to treatment discontinuation by patient background
Measured: Up to 1 year
Overall survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
Measured: Up to 1 year
Time to next treatment of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
Measured: Up to 1 year
Treatment-free survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
Measured: Up to 1 year
Treatment continuation rate of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
Measured: Up to 1 year
Incidence of CTCAE v 5.0 Grade 3 or higher irAEs of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
Measured: Up to 1 year
Incidence of TRAEs leading to treatment discontinuation of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
Measured: Up to 1 year
Time to onset of immune-related adverse events (irAEs) to be collected, treatment for these events and time to symptom improvement, and impact on effectiveness
Measured: Up to 1 year
Duration of treatment of second-line treatment
Measured: Up to 1 year
Reasons for treatment discontinuation of second-line treatment
Measured: Up to 1 year
Treatment related death of second-line treatment
Measured: Up to 1 year
Response rate of second-line treatment
Measured: Up to 1 year
Overall survival in participants who discontinued treatment due to treatment-related adverse events within 90 days
Measured: Up to 1 year
Time to next treatment in participants who discontinued treatment due to treatment-related adverse events within 90 days
Measured: Up to 1 year
Treatment-free survival in participants who discontinued treatment due to treatment-related adverse events within 90 days
Measured: Up to 1 year
Treatment continuation rate in participants who discontinued treatment due to treatment-related adverse events within 90 days
Measured: Up to 1 year
Duration of treatment of second-line treatment in participants with disease progression within 90 days
Measured: Up to 1 year
Reasons for treatment discontinuation of second-line treatment in participants with disease progression within 90 days
Measured: Up to 1 year
Overall survival of second-line treatment in participants with disease progression within 90 days
Measured: Up to 1 year
Response rate of second-line treatment in participants with disease progression within 90 days
Measured: Up to 1 year
Treatment related death of second-line treatment in participants with disease progression within 90 days
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start15 Dec 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharma USA Inc
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161325
- Sponsor's protocol ID
- CA209-64A
- Acronym
- LIGHT-NING
- Status last verified
- Jun 2026
- First submitted
- 6 Dec 2021
- Last updated
- 2 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05161325
- Acronym / sponsor ID
- LIGHT-NING / CA209-64A
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- BMS-936558, ONO-4538, Nivolumab, Ipilimumab, Retrospective, Observational
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 525 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharma USA Inc
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to assess the effectiveness and safety of Nivolumab plus Ipilimumab with or without chemotherapy as first-line treatment for participants with untreated advanced or recurrent NSCLC in the real world setting in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with untreated advanced or recurrent non-small cell lung cancer (NSCLC) receiving first-line nivolumab plus ipilimumab with or without chemotherapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a descriptive study of participants who received nivolumab plus ipilimumab with or without chemotherapy within 1 year of approval. In this study, the target sample size is set at 500 participants based on the feasibility to investigate the actual clinical practice.
Key inclusion criteria (3 listed)
- Histologically confirmed advanced or recurrent NSCLC
- Participants 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 November 30, 2021.
Key exclusion criteria (9 listed)
- In participants with non-squamous histology, participants 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.
- Participants 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, participants who correspond to a) or b) below will be included in this study.
- Prior perioperative chemotherapy or Stage III chemoradiotherapy or durvalumab combination chemoradiotherapy.
- Participants who are received or have received bisphosphonates or denosumab for bone metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of treatment
Time frame: Up to 1 year
Time from the initiation date of nivolumab plus ipilimumab with or without chemotherapy among eligible participants to the last date of treatment as an event.
Rates of participants with second-line treatment
Time frame: Up to 1 year
The rate of eligible participants who have completed nivolumab plus ipilimumab with or without chemotherapy during the observation period and have initiated second-line treatment
Overall survival (OS)
Time frame: Up to 1 year
Defined as the time between the date of initiation of nivolumab plus ipilimumab with or without chemotherapy and the date of death from any cause among eligible participants.
Incidence of Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 Grade 3 or higher immune-related adverse events [irAEs]
Time frame: Up to 1 year
Time to next treatment [(TNT)
Time frame: Up to 1 year
Defined as the time between the date of combination therapy with nivolumab plus ipilimumab with or without chemotherapy initiation among eligible participants and the date of second-line treatment initiation or the date of death from any cause, whichever occurs first.
Treatment-free survival (TFS)
Time frame: Up to 1 year
Defined as the time between the date of nivolumab plus ipilimumab with or without chemotherapy cessation among eligible participants and the date of second-line treatment initiation or the date of death from any cause, whichever occurs first.
Treatment continuation rate
Time frame: Up to 1 year
The rate of eligible participants who have continued nivolumab plus ipilimumab with or without chemotherapy during the observation period.
Incidence of treatment-related adverse events (TRAEs) leading to treatment discontinuation
Time frame: Up to 1 year
30 secondary outcomes
Progression-free survival (PFS) in participants assessed for tumor response according to RECIST v 1.1
Time frame: Up to 1 year
Objective response rate (ORR) in participants evaluated for tumor response according to RECIST v 1.1
Time frame: Up to 1 year
Disease control rate (DCR) in participants evaluated for response in accordance with RECIST v 1.1
Time frame: Up to 1 year
Duration of response (DOR) in participants evaluated for tumor response in accordance with RECIST v 1.1
Time frame: Up to 1 year
Overall Survival (OS) by patient background
Time frame: Up to 1 year
Time to next treatment (TNT) by patient background
Time frame: Up to 1 year
Treatment-free survival (TFS) by patient background
Time frame: Up to 1 year
Treatment continuation rate by patient background
Time frame: Up to 1 year
Incidence of CTCAE v 5.0 Grade 3 or higher irAEs by patient background
Time frame: Up to 1 year
Incidence of TRAEs leading to treatment discontinuation by patient background
Time frame: Up to 1 year
Overall survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
Time frame: Up to 1 year
Time to next treatment of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
Time frame: Up to 1 year
Treatment-free survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
Time frame: Up to 1 year
Treatment continuation rate of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
Time frame: Up to 1 year
Incidence of CTCAE v 5.0 Grade 3 or higher irAEs of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
Time frame: Up to 1 year
Incidence of TRAEs leading to treatment discontinuation of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
Time frame: Up to 1 year
Time to onset of immune-related adverse events (irAEs) to be collected, treatment for these events and time to symptom improvement, and impact on effectiveness
Time frame: Up to 1 year
Duration of treatment of second-line treatment
Time frame: Up to 1 year
Reasons for treatment discontinuation of second-line treatment
Time frame: Up to 1 year
Treatment related death of second-line treatment
Time frame: Up to 1 year
Response rate of second-line treatment
Time frame: Up to 1 year
Overall survival in participants who discontinued treatment due to treatment-related adverse events within 90 days
Time frame: Up to 1 year
Time to next treatment in participants who discontinued treatment due to treatment-related adverse events within 90 days
Time frame: Up to 1 year
Treatment-free survival in participants who discontinued treatment due to treatment-related adverse events within 90 days
Time frame: Up to 1 year
Treatment continuation rate in participants who discontinued treatment due to treatment-related adverse events within 90 days
Time frame: Up to 1 year
Duration of treatment of second-line treatment in participants with disease progression within 90 days
Time frame: Up to 1 year
Reasons for treatment discontinuation of second-line treatment in participants with disease progression within 90 days
Time frame: Up to 1 year
Overall survival of second-line treatment in participants with disease progression within 90 days
Time frame: Up to 1 year
Response rate of second-line treatment in participants with disease progression within 90 days
Time frame: Up to 1 year
Treatment related death of second-line treatment in participants with disease progression within 90 days
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of treatment (time frame: Up to 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.