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

Prior treatment

• 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

Lab values

• 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.

• 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.

Criteria the registry did not label

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