DARWIN EU® Overall survival in patients with locally advanced or metastatic non-small cell lung cancer treated with selected immunotherapies as first line of treatment

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  IMFINZI

  KEYTRUDA

  LIBTAYO

  OPDIVO

  TECENTRIQ

  YERVOY
• Name of medicine, other:
  o Chemotherapies (cisplatin, carboplatin, pemetrexed, paclitaxel, docetaxel, gemcitabine, and vinorelbine); given as monotherapy or in combination (as per the label) and as first line of treatment.;
• Study drug International non-proprietary name (INN) or common name:
  ATEZOLIZUMAB

  CARBOPLATIN

  CEMIPLIMAB

  CISPLATIN

  DOCETAXEL

  DURVALUMAB

  IPILIMUMAB

  NIVOLUMAB

  PACLITAXEL

  PEMBROLIZUMAB

  PEMETREXED
• Anatomical Therapeutic Chemical (ATC) code:
  (L01BA04) pemetrexed

  pemetrexed

  (L01BC05) gemcitabine

  gemcitabine

  (L01CA04) vinorelbine

  vinorelbine

  (L01CD01) paclitaxel

  paclitaxel

  (L01CD02) docetaxel

  docetaxel

  (L01FF01) nivolumab

  nivolumab

  (L01FF02) pembrolizumab

  pembrolizumab

  (L01XA01) cisplatin

  cisplatin

  (L01XA02) carboplatin

  carboplatin

  (L01XC11) ipilimumab

  ipilimumab

  (L01XC28) durvalumab

  durvalumab

  (L01XC32) atezolizumab

  atezolizumab

  (L01XC33) cemiplimab

  cemiplimab
• Medical condition to be studied:
  Non-small cell lung cancer metastatic

  Non-small cell lung cancer

  Non-small cell lung cancer stage IIIA

  Non-small cell lung cancer stage III

  Non-small cell lung cancer stage IIIB

Population studied

• Short description of the study population:
  Patients with locally advanced or metastatic NSCLC.
• Age groups:
  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

Study design details

• Study design:
  New user matched cohort study.
• Main study objective:
  The overall aim of this study is to assess the overall survival of patients with locally advanced or metastatic NSCLC who initiate first-line treatment with selected immunotherapies (pembrolizumab, atezolizumab, cemiplimab, nivolumab, durvalumab, and ipilimumab) and how it compares to the survival of locally advanced or metastatic NSCLC patients treated with chemotherapies as first line.
• Data analysis plan:
  All analyses will be conducted separately for each database, and will be carried out in a federated manner, allowing analyses to be run locally without sharing patient-level data.; First, we will run cohort diagnostics to evaluate data availability and data quality in terms of identification of locally advanced or metastatic NSCLC as well as recording of cancer treatments of interest. ; Before sharing the study package, test runs of the analytics will be performed on a subset of the data sources and quality control checks will be performed. After all the tests are passed (see section 10 Quality Control), the final package will be released in a version-controlled study repository for execution against all the participating data sources. ; Data partners will locally execute the analytics against the OMOP-CDM in R Studio and review and approve the default aggregated results. They will then be made available to the Principal Investigators and study team in secure online repository (Data Transfer Zone). All results will be locked and timestamped for reproducibility and transparency. ; All analyses will be reported by database, overall and stratified by age and sex when possible (minimum cell count reached). Results from objective 1 will further be stratified by calendar year.;