Clinical trial NCT07024862: 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
Official title: 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Non-small Cell Lung Cancer
Keywords: Metastatic non-small cell lung cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adults diagnosed with programmed death-ligand 1 (PD-L1) \<1% metastatic non-small cell lung cancer (NSCLC) and treated with 1L combination nivolumab, ipilimumab, and 2 cycles of platinum-doublet chemotherapy (NIC) in the US community oncology setting

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


Eligibility criteria: 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 outcomes:
measure: Participant baseline socio-demographics
timeFrame: Baseline
measure: Participant baseline clinical characteristics
timeFrame: Baseline
measure: Participant treatment history
timeFrame: Baseline
measure: Treatment start and stop dates
timeFrame: Up to 6-months
measure: Reasons for 1L treatment selection
timeFrame: Day 1
measure: Initial 1L NIC treatment dose received
timeFrame: Day 1
measure: Type of chemotherapy received as part of NIC treatment
timeFrame: Day 1
measure: Participant NIC treatment chemotherapy schedule
timeFrame: Day 1
measure: Number of NIC treatment interruptions
timeFrame: Up to 6-months
measure: Date(s) of NIC treatment interruptions
timeFrame: Up to 6-months
measure: Reasons for NIC treatment interruptions
timeFrame: Up to 6-months
measure: Length of NIC treatment delay/interruption
timeFrame: Up to 6-months
measure: Reasons for NIC treatment discontinuation
timeFrame: Up to 6-months
measure: Type of 2L treatment received
timeFrame: Up to 6-months
measure: Reasons for not initiating 2L treatment
timeFrame: Up to 6-months
measure: Start and stop dates of 2L treatment initiation
timeFrame: Up to 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: United States
facility: Cardinal Health
state: Ohio
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb Squibb
role: STUDY_DIRECTOR
References: