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Completed
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%
Conditions: Non-small Cell Lung Cancer (NSCLC)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 300
Sponsor: Bristol-Myers Squibb
Location: Florida Cancer Specialists & Research Institute Fleming Island Florida
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 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
Source: ClinicalTrials.gov (NCT07215962). StuddyBuddy aggregates publicly available trial information.