RAStik: A Retrospective Cohort Analysis of Survival and Treatment Outcomes of Docetaxel in KRAS G12C Mutated Locally Advanced or Metastatic NSCLC (20190411)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective observational study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DOCETAXEL
• Medical condition to be studied:
  Non-small cell lung cancer

Population studied

• Short description of the study population:
  Patients aged 18 years or older diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) received treatment with docetaxel (monotherapy or combination) between 1 July 2015 to 31 December 2019 identified from the Network Genomic Medicine (NGM) network database.; Inclusion criteria:; 1. Adults (aged ≥18) patients diagnosed between 1 July 2015 to 30 June 2019 with pathologically documented locally advanced or metastatic NSCLC from the Colonge center; 2. Have a record of treatment with docetaxel (monotherapy or combination) in ≥second line (eg. 2nd line, 3rd line, 4th line, or 4th line+); 3. Have a molecular test results of KRAS G12C somatic mutation recorded before start date of treatment with docetaxel; 4. Have FFPE tumor samples with adequate material available for biomarker testing (ie. >10% of tumor cells are available on sample) that was archived before start date of treatment with docetaxel; 5. Have CT-scan or MRI documentation of measurable disease at treatment baseline for docetaxel (ie., ≤4 weeks before start date of treatment); 6. Have documented consent that their medical data and residual tissue samples can be used for research purposes ; ; Exclusion criteria:; 1. Have a history of treatment with chemotherapy, immunotherapies, targeted therapies, or anti-angiogenic agents as part of a clinical trial.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with non-small cell lung cancer
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  The main objectives of this study are to evaluate the real-world effectiveness of docetaxel (monotherapy or combination) and estimate the overall survival and progression-free survival in ? second-line treatment of patients with KRAS G12C mutated locally advanced or metastatic NSCLC.
• Outcomes:
  • Real-world Objective Response Rate • Duration of overall response (DOR) • Disease control rate (DCR) • Duration of Treatment (DOT) • Time to Next Therapy (TTNT) • Time to Progression (TTP) • Overall survival (OS) • real-world Progression-free survival (rwPFS), • Patient Characteristics
• Data analysis plan:
  The primary outcomes are rwORR, OS and rwPFS. Non-parametric methods will be used to estimate OS and rwPFS. To describe time-to-event (rwORR, CR, PR, SD, PD, rwPFS, and OS), Kaplan-Meier (KM) curves will be plotted, and survival probabilities 95% confidence intervals (CIs) will be presented (eg, 6 months and 12 months). Median OS and rwPFS and 95% CI will be presented. Survival differences may be assessed for statistical significance using two-sided Log-Rank in Kaplan-Meier. The level of significance will be set at 0.05. For analyses of rwORR and survival, the index date will be determined by the start date of the type of treatment or start date of LOT, depending on the analysis. Duration or time to events (DOR, DCR, TTNT, and TTP) will be summarized (mean, median, standard deviation, range). Patient characteristics of patients with locally advanced or metastatic NSCLC will be described using summary statistics.

Documents

Study results

20190411_ORSR_Abstract_Redacted