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

NCT07024862 · tracked via the Priya Life Science USA tracker

Sponsor

Bristol-Myers Squibb

Phase

Observational

Started

2024-10-24

Last updated

2025-06-17

Condition(s) studied

Metastatic Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

nivolumab + ipilimumab

nivolumab + ipilimumab: First-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC)

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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)

Primary outcome measure(s)

Participant baseline socio-demographics — Baseline
Participant baseline clinical characteristics — Baseline
Participant treatment history — Baseline
Treatment start and stop dates — Up to 6-months
Reasons for 1L treatment selection — Day 1
Initial 1L NIC treatment dose received — Day 1
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Type of chemotherapy received as part of NIC treatment — Day 1
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Participant NIC treatment chemotherapy schedule — Day 1
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Number of NIC treatment interruptions — Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Date(s) of NIC treatment interruptions — Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Reasons for NIC treatment interruptions — Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Length of NIC treatment delay/interruption — Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Reasons for NIC treatment discontinuation — Up to 6-months
NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy
Type of 2L treatment received — Up to 6-months
Reasons for not initiating 2L treatment — Up to 6-months
Start and stop dates of 2L treatment initiation — Up to 6-months

Trial sites (1)

Facility	City	Region	Status
Cardinal Health	Dublin	Ohio

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07024862 on ClinicalTrials.gov ↗ ← All trials in the USA