Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Two-year real-world overall survival (rwOS) rate of patients with NSQ mNSCLC in the total study population | rwOS rate (percentage of patients being alive derived by Kaplan-Meier methods) at 24 months in the total 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6, 12 and 18 months |
| Median overall survival (mOS) in the total study population |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Adult patients (≥18 years) with a histologically or cytologically confirmed NSQ mNSCLC (incl. LCNEC if considered NSCLC-like by the treating physician), planned treatment initiation with TDC according to applicable Summary of product characteristics (SmPCs) within routine clinical practice and initiated molecular gene panel analysis (including KRAS, STK11, KEAP1, and TP53) as well as PD-L1 and TTF-1 expression analyses are eligible for enrolment.
Eligible patients will be included into the study after and independently of the treating physician's treatment and diagnostic decisions but no later than 21 days after application of the first TDC treatment cycle.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Bad Homburg | Germany | |||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca (AZ) group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Not provided
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Not provided
Not provided
Not provided
Not provided
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 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. | 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. | 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 |
| Recruiting |
| Berlin |
| Germany |
| Research Site | Recruiting | Bremen | Germany |
| Research Site | Withdrawn | Celle | Germany |
| Research Site | Recruiting | Chemnitz | Germany |
| Research Site | Recruiting | Cologne | Germany |
| Research Site | Recruiting | Deggendorf | Germany |
| Research Site | Recruiting | Frankfurt | Germany |
| Research Site | Recruiting | Georgsmarienhütte | Germany |
| Research Site | Withdrawn | Gera | Germany |
| Research Site | Recruiting | Goslar | Germany |
| Research Site | Recruiting | Greifswald | Germany |
| Research Site | Recruiting | Halle-Dolau | Germany |
| Research Site | Recruiting | Hanover | Germany |
| Research Site | Recruiting | Herne | Germany |
| Research Site | Recruiting | Hösbach | Germany |
| Research Site | Recruiting | Koln-Mehrheim | Germany |
| Research Site | Recruiting | Mainz | Germany |
| Research Site | Recruiting | Marburg | Germany |
| Research Site | Recruiting | Münnerstadt | Germany |
| Research Site | Recruiting | Neuss | Germany |
| Research Site | Recruiting | Offenbach | Germany |
| Research Site | Recruiting | Querfurt | Germany |
| Research Site | Recruiting | Ravensburg | Germany |
| Research Site | Recruiting | Rüsselsheim am Main | Germany |
| Research Site | Recruiting | Treuenbrietzen | Germany |
| Research Site | Recruiting | Ulm | Germany |
| Research Site | Recruiting | Wiesbaden | Germany |
| Research Site | Recruiting | Zwickau | Germany |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
Not provided
Not provided