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NCT Number: NCT07215962

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Florida Cancer Specialists & Research Institute

Fleming Island, Florida, 32003, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab + ipilimumab

Biological

According to the product label

Nivolumab + ipilimumab + platinum-based chemotherapy

Biological

According to the product label

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

Biological

According to the product label

Other dual-immuno-oncology therapy with chemotherapy

Biological

According to the product label

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 14, 2025
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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