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

NCT07215962 · tracked via the Priya Life Science USA tracker

Sponsor

Bristol-Myers Squibb

Phase

Observational

Started

2024-11-22

Last updated

2025-10-14

Condition(s) studied

Non-small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

Nivolumab + ipilimumabAll Nivolumab trials (280) →All Ipilimumab trials (133) →Nivolumab + ipilimumab + platinum-based chemotherapyAll Nivolumab trials (280) →All Ipilimumab trials (133) →Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapyOther dual-immuno-oncology therapy with chemotherapy

Nivolumab + ipilimumab: According to the product label

Nivolumab + ipilimumab + platinum-based chemotherapy: According to the product label

Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy: According to the product label

Other dual-immuno-oncology therapy with chemotherapy: According to the product label

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Incidence of treatment-related adverse events — Baseline
Participant baseline clinical characteristics — Baseline
Time to onset of treatment-related adverse events — Up to 8 years
Number of treatment-related adverse events resolved — Up to 8 years
Number of participants receiving treatment for treatment-related adverse events by drug class — Up to 8 years
Number of participants that discontinued immune-oncology therapy due to treatment-related adverse events — Up to 8 years

Trial sites (1)

Facility	City	Region	Status
Florida Cancer Specialists & Research Institute	Fleming Island	Florida

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07215962 on ClinicalTrials.gov ↗ ← All trials in the USA