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

Study 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

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNivolumab + ipilimumab and Nivolumab + ipilimumab + platinum-based chemotherapy

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 14, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Bristol-Myers Squibb

Study sponsor

Study overview

What this study is about

Purpose: Not specified
Study type: Observational
Phase: Not applicable
Sponsor: Bristol-Myers Squibb
Interventions being studied: Biological: Nivolumab + ipilimumab; Biological: Nivolumab + ipilimumab + platinum-based chemotherapy; Biological: Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy; Biological: Other dual-immuno-oncology therapy with chemotherapy

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Biomarkers

PD-L1→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Florida Cancer Specialists & Research InstituteFleming Island, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 14, 2025. Always confirm current availability with the study team.

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