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 (LIGHT-NING)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Small Cell Lung Cancer

• Study Type: Observational
• Enrollment (Actual): 525

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Minato-ku, Tokyo, Japan, 1070052
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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.

  1. 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.

Exclusion Criteria:

• 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.

1. Prior perioperative chemotherapy or Stage III chemoradiotherapy or durvalumab combination chemoradiotherapy.

2. 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.
   • 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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]		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.	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.	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.	Up to 1 year
Incidence of treatment-related adverse events (TRAEs) leading to treatment discontinuation		Up to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS) in participants assessed for tumor response according to RECIST v 1.1	Up to 1 year
Objective response rate (ORR) in participants evaluated for tumor response according to RECIST v 1.1	Up to 1 year
Disease control rate (DCR) in participants evaluated for response in accordance with RECIST v 1.1	Up to 1 year
Duration of response (DOR) in participants evaluated for tumor response in accordance with RECIST v 1.1	Up to 1 year
Overall Survival (OS) by patient background	Up to 1 year
Time to next treatment (TNT) by patient background	Up to 1 year
Treatment-free survival (TFS) by patient background	Up to 1 year
Treatment continuation rate by patient background	Up to 1 year
Incidence of CTCAE v 5.0 Grade 3 or higher irAEs by patient background	Up to 1 year
Incidence of TRAEs leading to treatment discontinuation by patient background	Up to 1 year
Overall survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors	Up to 1 year
Time to next treatment of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors	Up to 1 year
Treatment-free survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors	Up to 1 year
Treatment continuation rate of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors	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	Up to 1 year
Incidence of TRAEs leading to treatment discontinuation of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors	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	Up to 1 year
Duration of treatment of second-line treatment	Up to 1 year
Reasons for treatment discontinuation of second-line treatment	Up to 1 year
Treatment related death of second-line treatment	Up to 1 year
Response rate of second-line treatment	Up to 1 year
Overall survival in participants who discontinued treatment due to treatment-related adverse events within 90 days	Up to 1 year
Time to next treatment in participants who discontinued treatment due to treatment-related adverse events within 90 days	Up to 1 year
Treatment-free survival in participants who discontinued treatment due to treatment-related adverse events within 90 days	Up to 1 year
Treatment continuation rate in participants who discontinued treatment due to treatment-related adverse events within 90 days	Up to 1 year
Duration of treatment of second-line treatment in participants with disease progression within 90 days	Up to 1 year
Reasons for treatment discontinuation of second-line treatment in participants with disease progression within 90 days	Up to 1 year
Overall survival of second-line treatment in participants with disease progression within 90 days	Up to 1 year
Response rate of second-line treatment in participants with disease progression within 90 days	Up to 1 year
Treatment related death of second-line treatment in participants with disease progression within 90 days	Up to 1 year

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Ono Pharma USA Inc
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Nivolumab; Observational; Ipilimumab; Retrospective; BMS-936558; ONO-4538
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CA209-64A