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

NCT05161325 | Active Not Recruiting

• 1 other identifier: CA209-64A
• Study Type: observational
• Target: 525
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer

Keywords

BMS-936558; ONO-4538; Nivolumab; Ipilimumab; Retrospective; Observational

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (30)

• 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

Study Arms (1)

Cohort 1

Participants with untreated advanced or recurrent non-small cell lung cancer (NSCLC) receiving first-line nivolumab plus ipilimumab with or without chemotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharma USA Inc: collaborator

Study Sites (1)

Local Institution

Minato-ku, Tokyo, 1070052, Japan

Location

Related Links

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

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 17, 2021
• Study Start: December 15, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

JP (1)