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Active, not recruitingNCT07215962Updated Oct 14, 2025

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

An observational study in Non-small Cell Lung Cancer (NSCLC), sponsored by Bristol-Myers Squibb. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-14.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
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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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Conditions studied

  • Non-small Cell Lung Cancer (NSCLC)
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In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 300 is above the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will comprise of programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy in routine clinical practice at the Florida Cancer Specialists and Research Institute

Eligibility criteria

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cohort 1

    Participants receiving nivolumab + ipilimumab treatment

    Biological: Nivolumab + ipilimumab

  • Cohort 2

    Participants receiving nivolumab + ipilimumab + platinum-based chemotherapy

    Biological: Nivolumab + ipilimumab + platinum-based chemotherapy

  • Cohort 3

    Participants receiving immuno-oncology therapy (excl nivolumab) with chemotherapy treatment

    Biological: Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy

  • Cohort 4

    Participants receiving other dual-IO with chemotherapy

    Biological: Other dual-immuno-oncology therapy with chemotherapy

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

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What researchers measure

Primary outcomes

  1. Incidence of treatment-related adverse events

    Time frame: Baseline

  2. Participant baseline clinical characteristics

    Time frame: Baseline

  3. Time to onset of treatment-related adverse events

    Time frame: Up to 8 years

  4. Number of treatment-related adverse events resolved

    Time frame: Up to 8 years

  5. Number of participants receiving treatment for treatment-related adverse events by drug class

    Time frame: Up to 8 years

  6. Number of participants that discontinued immune-oncology therapy due to treatment-related adverse events

    Time frame: Up to 8 years

Secondary outcomes

  1. Healthcare Resource Utilization (HCRU) associated with treatment-related adverse event

    Time frame: Up to 8 years

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Study locations

1 site
  • Florida Cancer Specialists & Research Institute
    Fleming Island, Florida 32003, United States
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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07215962
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Oct 14, 2025
Start date
Nov 22, 2024
Primary completion
Jul 1, 2025
Completion
Mar 1, 2026 (estimated)
Last update
Oct 14, 2025

Study contacts

Bristol Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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