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Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Programmed Death-1 (Pd-L1) <1%

Real-World Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Pd-L1 <1% in the Florida Cancer Specialists & Research Institute Database

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07215962
Enrollment
300
Registered
2025-10-14
Start date
2024-11-22
Completion date
2026-03-01
Last updated
2025-10-14

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

Conditions

Non-small Cell Lung Cancer (NSCLC)

Brief summary

The purpose of this study is to assess the treatment-related adverse events and associated healthcare resource use in programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy

Interventions

BIOLOGICALNivolumab + ipilimumab

According to the product label

BIOLOGICALNivolumab + ipilimumab + platinum-based chemotherapy

According to the product label

BIOLOGICALImmuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy

According to the product label

BIOLOGICALOther dual-immuno-oncology therapy with chemotherapy

According to the product label

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion Criteria: * Are ≥ 18 years of age at the index date * Have a confirmed diagnosis of advanced/metastatic non-small cell lung cancer (NSCLC) (stage IIIB-IV) (squamous and non-squamous) * Have PD-L1\< 1% level as reported * Received one of the following 1L treatments: * Cohort 1: nivolumab + ipilimumab * Cohort 2: nivolumab + ipilimumab + platinum-based chemotherapy * Cohort 3: Immuno-oncology (IO)-based therapy (excluding nivolumab-based regimens) with chemotherapy * Cohort 4: Dual-IO with chemotherapy (eg. tremelimumab-actl + durvalumab + carboplatin + albumin-bound paclitaxel, tremelimumab-actl + durvalumab + \[carboplatin or cisplatin\] + gemcitabine, tremelimumab-actl + durvalumab + carboplatin + albumin-bound paclitaxel, tremelimumab-actl + durvalumab + \[carboplatin or cisplatin\] + pemetrexed) * Have ≥ 6 months of documented post-index (follow-up) period after the index date - Participants who die within 6 months of follow-up will be included

Exclusion criteria

* Have positive or unknown EGFR or ALK mutation before the index date * Have a gap of \> 120 days between metastatic NSCLC diagnosis and index date * Were included in a clinical trial for 1L therapy * Enter a hospice within 6 months of the follow-up will be excluded * Have other concurrent primary cancer diagnoses

Design outcomes

Primary

MeasureTime frame
Time to onset of treatment-related adverse eventsUp to 8 years
Incidence of treatment-related adverse eventsBaseline
Participant baseline clinical characteristicsBaseline
Number of participants that discontinued immune-oncology therapy due to treatment-related adverse eventsUp to 8 years
Number of treatment-related adverse events resolvedUp to 8 years
Number of participants receiving treatment for treatment-related adverse events by drug classUp to 8 years

Secondary

MeasureTime frame
Healthcare Resource Utilization (HCRU) associated with treatment-related adverse eventUp to 8 years

Countries

United States

Outcome results

None listed

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