NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations

Real-world overall survival (rwOS) in the total study population

rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 6, 12 and 18 months

Time frame: 6, 12 and 18 months

Median overall survival (mOS) in the total study population

OS is defined as the time from the date of first documented dose of TDC until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive. Median OS will be calculated using the Kaplan-Meier technique.

Time frame: up to 24 months

Real-world overall survival (rwOS) in a subgroup of patients with mutation in KRAS

rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 6, 12 and 18 months

Time frame: 6, 12 and 18 months

Median overall survival (mOS) in a subgroup of patients with mutation in KRAS

OS is defined as the time from the date of first documented dose of TDC until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive. Median OS will be calculated using the Kaplan-Meier technique.

Time frame: up to 24 months

Real-world overall survival (rwOS) in a subgroup of patients with mutation in STK11

rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 6, 12 and 18 months

Time frame: 6, 12 and 18 months

Median overall survival (mOS) in a subgroup of patients with mutation in STK11

OS is defined as the time from the date of first documented dose of TDC until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive. Median OS will be calculated using the Kaplan-Meier technique.

Time frame: up to 24 months

Real-world treatment response of TDC, as judged by the treating physician

Treatment response in terms of overall response rate (ORR), being defined as the proportion of patients with complete response (CR) or partial response (PR) as best overall response, CR or PR, at ≥1 visit during treatment with TDC.

Time frame: up to 24 months

Duration of response (DoR)

Duration of response (DoR), being defined as time from documented CR or PR until documentation of progressive disease (PD), or death by any cause will be analyzed with Kaplan-Meier methods. Patients without documentation of PD will be censored with their last date in the database known to be without PD, or the end of study date, whichever occurs first. Patients who received a subsequent line mNSCLC therapy after TDC before disease progression or death will be censored with the start date of this new therapy.

Time frame: up to 24 months

Real-world progression-free survival (rwPFS)

rwPFS is defined as time from patient's index date until first date of PD or death by any cause and will be analyzed by Kaplan-Meier methods.

Time frame: up to 24 months

Safety: Collection of Adverse Events (AE)

Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness.

Time frame: up to 24 months