Nivolumab + ipilimumabNivolumab + ipilimumab + platinum-based chemotherapyImmuno-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
No
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
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
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.
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