Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

DOCETAXEL

Name of medicine, other

LUMAKRAS® (sotorasib)
Drug 1: sotorasib
Drug 2: docetaxel

Study drug International non-proprietary name (INN) or common name

DOCETAXEL
SOTORASIB

Anatomical Therapeutic Chemical (ATC) code

(L01CD02) docetaxel
docetaxel
(L01XX73) sotorasib
sotorasib

Medical condition to be studied

Non-small cell lung cancer
Population studied

Short description of the study population

• Patients with advanced NSCLC will be identified from the Flatiron Health EDM
• Flatiron Health EDM includes over 280 community oncology practices and several academic centers throughout the US

Age groups

Adult and elderly population (≥18 years)
Adults (18 to < 65 years)
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)

Estimated number of subjects

471
Study design details

Study design

This study will comprise of two cohorts: Sotorasib cohort: KRAS p.G12C-mutated advanced NSCLC patients who initiated sotorasib monotherapy in 2L/2L+ between 28 May 2021 (date of US FDA approval) and 30 Sep 2022; Docetaxel cohort: KRAS p.G12C-mutated advanced NSCLC patients who initiated docetaxel.

Main study objective

To compare overall survival in KRAS p.G12C-mutated advanced NSCLC patients initiating treatment with sotorasib monotherapy versus docetaxel monotherapy or combination therapy in second line (2L) setting, within the US FH EDM.

Setting

Community oncology practices and several academic centers throughout the US.

Comparators

Docetaxel monotherapy or combination therapy in 2L+ setting.

Outcomes

Primary Outcome:
• Overall survival (OS) of participants treated with sotorasib monotherapy versus docetaxel monotherapy or combination therapy in 2L setting.
Secondary Outcome:
• OS of participants treated with sotorasib monotherapy versus docetaxel monotherapy or combination therapy in 2L+ setting.

Data analysis plan

Nonparametric methods will be used to estimate OS. Median OS and corresponding 95% confidence intervals (CIs) will be calculated using Kaplan-Meier estimates. The estimated survival probabilities for OS and corresponding 95% CIs will be presented for patients at 6- and 12-months.