NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations
NCT Number: NCT06494540
Acronym: NAUTIC
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Non-squamous Metastatic Non-Small-Cell Lung Carcinoma
Sponsor: AstraZeneca
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-28
Completion Date: 2028-06-30
Locations: Research Site, Berlin, Germany|Research Site, Chemnitz, Germany|Research Site, Georgsmarienhutte, Germany|Research Site, Hannover, Germany|Research Site, Munnerstadt, Germany

Summary:
This prospective, multicenter, non-interventional study (NIS) in Germany aims to collect real-life data of patients with non-squamous (NSQ) metastatic non-small cell lung cancer (mNSCLC) (incl. large cell neuroendocrine carcinoma (LCNEC) if considered NSCLC-like by the treating physician) for whom 1st line treatment initiation with tremelimumab and durvalumab in combination with a platinum-based chemotherapy (TDC) according to marketing authorization was scheduled. The study aims to describe the effectiveness with respect to mutations in Kirsten rat sarcoma viral oncogene homolog (KRAS), Serine/threonine kinase 11 (STK11), Kelch-like ECH-associated protein 1 (KEAP1), and Tumor protein p53 (TP53) as well as expression of Thyroid transcription factor 1 (TTF-1) and Programmed death-ligand 1 (PD-L1) in routine clinical practice. The generated data aims to deepen the understanding of optimal, biomarker-guided treatment strategies for NSQ mNSCLC in distinct subgroups with a high medical need.

Primary Outcome Measures: Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in the overall study population, rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in the overall study population. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first., Time from patient's index date until death by any cause, up to 24 months|Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in KRAS, rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in patients with mutations in KRAS. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first., Time from patient's index date until death by any cause, up to 24 months|Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in STK11, rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in patients with mutations in STK11. Patients without a date of death will be censored at last activity in the database, or the end of the study period, whichever occurs first., Time from patient's index date until death by any cause, up to 24 months
Secondary Outcome Measures: Real-world overall survival (rwOS) in the overall study population, rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 6, 12 and 18 months, 6, 12 and 18 months|Median overall survival (mOS) in the overall 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., 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, 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., 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, 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., 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., 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 at last activity in the database or the end of the study period, whichever occurs first., up to 24 months|Real-world progression-free survival (rwPFS), rwPFS is defined as time from patient's index date until first date of confirmed PD or death by any cause and will be analyzed by Kaplan-Meier methods., 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., up to 24 months