Long-term Outcomes Among Patients With Programmed Death-ligand 1 <1% Metastatic Non-small Cell Lung Cancer Treated With First-line Nivolumab + Ipilimumab + 2 Cycles of Chemotherapy

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Metastatic Non-small Cell Lung Cancer

Treatments: Biological: nivolumab + ipilimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT07024862

CA209-1496

Details and patient eligibility

About

The study will assess the long-term real-world outcomes among adults diagnosed with programmed death-ligand 1 (PD-L1) <1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years old at confirmed diagnosis with metastatic non-small cell lung cancer (NSCLC) (stage IV), squamous or non-squamous histology
• Initiated first-line (1L) combination nivolumab, ipilimumab, and 2 cycles of platinum-doublet chemotherapy (NIC) regimen between 01 January 2018 and 2 years prior to study launch
• Tumor programmed death-ligand 1 (PD-L1) negative expression (i.e., PD-L1 <1%)
• No EGFR, ALK, or ROS1 genetic mutation (i.e., wild type)
• Minimum of 6 months of follow-up after initiation of 1L NIC*

Exclusion criteria

• Any prior systemic therapy for metastatic non-small cell lung cancer (NSCLC)

Trial design

100 participants in 1 patient group

Cohort 1

Description:

Adults diagnosed with programmed death-ligand 1 (PD-L1) \<1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US

Treatment:

Biological: nivolumab + ipilimumab