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

Long-Term Real-World Outcomes Among Patients 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)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07024862

Enrollment

100

Registered

2025-06-17

Start date

2024-10-24

Completion date

2025-06-30

Last updated

2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Non-small Cell Lung Cancer

Keywords

Metastatic non-small cell lung cancer

Brief 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

Interventions

BIOLOGICALnivolumab + ipilimumab

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026