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

Non-Small Cell Lung Cancer Clinical Trial

— LIGHT-NING  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05161325
• Other study ID #: CA209-64A
• Status: Completed
• Start date: December 15, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: December 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
Japan	Local Institution	Minato-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharma USA Inc

Country where clinical trial is conducted

Japan, 

Outcome

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

External Links

•   BMS Clinical Trial Information
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•   Investigator Inquiry Form