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NCT Number: NCT05161325

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Minato-ku, Tokyo, 1070052, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.

  • 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.
  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. Incidence of treatment-related adverse events (TRAEs) leading to treatment discontinuation

    Time frame: Up to 1 year

Secondary outcomes

  1. Progression-free survival (PFS) in participants assessed for tumor response according to RECIST v 1.1

    Time frame: Up to 1 year

  2. Objective response rate (ORR) in participants evaluated for tumor response according to RECIST v 1.1

    Time frame: Up to 1 year

  3. Disease control rate (DCR) in participants evaluated for response in accordance with RECIST v 1.1

    Time frame: Up to 1 year

  4. Duration of response (DOR) in participants evaluated for tumor response in accordance with RECIST v 1.1

    Time frame: Up to 1 year

  5. Overall Survival (OS) by patient background

    Time frame: Up to 1 year

  6. Time to next treatment (TNT) by patient background

    Time frame: Up to 1 year

  7. Treatment-free survival (TFS) by patient background

    Time frame: Up to 1 year

  8. Treatment continuation rate by patient background

    Time frame: Up to 1 year

  9. Incidence of CTCAE v 5.0 Grade 3 or higher irAEs by patient background

    Time frame: Up to 1 year

  10. Incidence of TRAEs leading to treatment discontinuation by patient background

    Time frame: Up to 1 year

  11. Overall survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors

    Time frame: Up to 1 year

  12. Time to next treatment of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors

    Time frame: Up to 1 year

  13. Treatment-free survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors

    Time frame: Up to 1 year

  14. Treatment continuation rate of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors

    Time frame: Up to 1 year

  15. 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

  16. 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

  17. 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

  18. Duration of treatment of second-line treatment

    Time frame: Up to 1 year

  19. Reasons for treatment discontinuation of second-line treatment

    Time frame: Up to 1 year

  20. Treatment related death of second-line treatment

    Time frame: Up to 1 year

  21. Response rate of second-line treatment

    Time frame: Up to 1 year

  22. Overall survival in participants who discontinued treatment due to treatment-related adverse events within 90 days

    Time frame: Up to 1 year

  23. Time to next treatment in participants who discontinued treatment due to treatment-related adverse events within 90 days

    Time frame: Up to 1 year

  24. Treatment-free survival in participants who discontinued treatment due to treatment-related adverse events within 90 days

    Time frame: Up to 1 year

  25. Treatment continuation rate in participants who discontinued treatment due to treatment-related adverse events within 90 days

    Time frame: Up to 1 year

  26. Duration of treatment of second-line treatment in participants with disease progression within 90 days

    Time frame: Up to 1 year

  27. Reasons for treatment discontinuation of second-line treatment in participants with disease progression within 90 days

    Time frame: Up to 1 year

  28. Overall survival of second-line treatment in participants with disease progression within 90 days

    Time frame: Up to 1 year

  29. Response rate of second-line treatment in participants with disease progression within 90 days

    Time frame: Up to 1 year

  30. Treatment related death of second-line treatment in participants with disease progression within 90 days

    Time frame: Up to 1 year

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharma USA Inc

Registry information

Official study 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

Acronym: LIGHT-NING

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Dec 17, 2021
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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