An observational study in Non-squamous Metastatic Non-Small-Cell Lung Carcinoma, sponsored by AstraZeneca. Recruiting at 30 sites in Germany. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by AstraZeneca · Observational
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.
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.
Exclusion Criteria:
Mixed histology NSCLC with both adenocarcinoma and squamous cell carcinoma components (adenosquamous carcinoma or any mixed NSQ- squamous tumor), regardless of the predominant component
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 frame: 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 frame: 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 frame: Time from patient's index date until death by any cause, up to 24 months
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
Plan to share: Yes — 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.
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