NIS to Examine the Effectiveness of TDC in Patients With Metastatic Non-squamous NSCLC and High-risk Genetic Alterations
- Conditions
- Non-squamous Metastatic Non-Small-Cell Lung Carcinoma
- Registration Number
- NCT06494540
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- Aged ≥ 18 years
- Decision to start first-line (1L) treatment with TDC according to the current SmPCs
- Histologically or cytologically confirmed diagnosis of NSQ mNSCLC (incl. LCNEC if considered NSCLC-like by the treating physician)
- Treatment-naïve for metastatic disease
- No sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) alterations
- Molecular Next Generation Sequencing (NGS) panel as per institutional standard has been initiated (including the following genes: KRAS, STK11, KEAP1, and TP53)
- TTF-1 expression analysis has been initiated
- PD-L1 expression analysis has been initiated
- Women of childbearing potential must use effective contraception during treatment with durvalumab and for at least 3 months after the last dose of durvalumab
- Ability to understand the study concept
- Provision of signed informed consent form in accordance with applicable local provisions
- Current participation in interventional clinical trials
- Contraindications according to current SmPCs
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in the overall study population Time from patient's index date until death by any cause, up to 24 months 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.
Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in KRAS Time from patient's index date until death by any cause, up to 24 months 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.
Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in patients with mutations in STK11 Time from patient's index date until death by any cause, up to 24 months 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.
- Secondary Outcome Measures
Name Time Method Real-world overall survival (rwOS) in the overall study population 6, 12 and 18 months rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 6, 12 and 18 months
Safety: Collection of Adverse Events (AE) up to 24 months Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness.
Real-world overall survival (rwOS) in a subgroup of patients with mutation in KRAS 6, 12 and 18 months rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 6, 12 and 18 months
Median overall survival (mOS) in a subgroup of patients with mutation in KRAS up to 24 months 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.
Real-world treatment response of TDC, as judged by the treating physician up to 24 months 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.
Duration of response (DoR) up to 24 months 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.
Median overall survival (mOS) in the overall study population up to 24 months 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.
Real-world progression-free survival (rwPFS) up to 24 months 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.
Real-world overall survival (rwOS) in a subgroup of patients with mutation in STK11 6, 12 and 18 months rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 6, 12 and 18 months
Median overall survival (mOS) in a subgroup of patients with mutation in STK11 up to 24 months 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.
Trial Locations
- Locations (1)
Research Site
🇩🇪Wiesbaden, Germany