Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: BMS-936558
ONO-4538
Nivolumab
Ipilimumab
Retrospective
Observational
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharma USA Inc
First posted: 2021-12-17
Enrollment: 525
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Duration of treatment
timeFrame: Up to 1 year
measure: Rates of participants with second-line treatment
timeFrame: Up to 1 year
measure: Overall survival (OS)
timeFrame: Up to 1 year
measure: Incidence of Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 Grade 3 or higher immune-related adverse events [irAEs]
timeFrame: Up to 1 year
measure: Time to next treatment [(TNT)
timeFrame: Up to 1 year
measure: Treatment-free survival (TFS)
timeFrame: Up to 1 year
measure: Treatment continuation rate
timeFrame: Up to 1 year
measure: Incidence of treatment-related adverse events (TRAEs) leading to treatment discontinuation
timeFrame: Up to 1 year
Secondary outcomes:
measure: Progression-free survival (PFS) in participants assessed for tumor response according to RECIST v 1.1
timeFrame: Up to 1 year
measure: Objective response rate (ORR) in participants evaluated for tumor response according to RECIST v 1.1
timeFrame: Up to 1 year
measure: Disease control rate (DCR) in participants evaluated for response in accordance with RECIST v 1.1
timeFrame: Up to 1 year
measure: Duration of response (DOR) in participants evaluated for tumor response in accordance with RECIST v 1.1
timeFrame: Up to 1 year
measure: Overall Survival (OS) by patient background
timeFrame: Up to 1 year
measure: Time to next treatment (TNT) by patient background
timeFrame: Up to 1 year
measure: Treatment-free survival (TFS) by patient background
timeFrame: Up to 1 year
measure: Treatment continuation rate by patient background
timeFrame: Up to 1 year
measure: Incidence of CTCAE v 5.0 Grade 3 or higher irAEs by patient background
timeFrame: Up to 1 year
measure: Incidence of TRAEs leading to treatment discontinuation by patient background
timeFrame: Up to 1 year
measure: Overall survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
timeFrame: Up to 1 year
measure: Time to next treatment of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
timeFrame: Up to 1 year
measure: Treatment-free survival of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
timeFrame: Up to 1 year
measure: Treatment continuation rate of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
timeFrame: Up to 1 year
measure: Incidence of CTCAE v 5.0 Grade 3 or higher irAEs of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
timeFrame: Up to 1 year
measure: Incidence of TRAEs leading to treatment discontinuation of nivolumab plus ipilimumab with or without chemotherapy by adjustment for confounding factors
timeFrame: Up to 1 year
measure: 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
timeFrame: Up to 1 year
measure: Duration of treatment of second-line treatment
timeFrame: Up to 1 year
measure: Reasons for treatment discontinuation of second-line treatment
timeFrame: Up to 1 year
measure: Treatment related death of second-line treatment
timeFrame: Up to 1 year
measure: Response rate of second-line treatment
timeFrame: Up to 1 year
measure: Overall survival in participants who discontinued treatment due to treatment-related adverse events within 90 days
timeFrame: Up to 1 year
measure: Time to next treatment in participants who discontinued treatment due to treatment-related adverse events within 90 days
timeFrame: Up to 1 year
measure: Treatment-free survival in participants who discontinued treatment due to treatment-related adverse events within 90 days
timeFrame: Up to 1 year
measure: Treatment continuation rate in participants who discontinued treatment due to treatment-related adverse events within 90 days
timeFrame: Up to 1 year
measure: Duration of treatment of second-line treatment in participants with disease progression within 90 days
timeFrame: Up to 1 year
measure: Reasons for treatment discontinuation of second-line treatment in participants with disease progression within 90 days
timeFrame: Up to 1 year
measure: Overall survival of second-line treatment in participants with disease progression within 90 days
timeFrame: Up to 1 year
measure: Response rate of second-line treatment in participants with disease progression within 90 days
timeFrame: Up to 1 year
measure: Treatment related death of second-line treatment in participants with disease progression within 90 days
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: