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
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Among 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca — 25 open to participants now, 78 under way, 28 of them phase 3. Carcinoma, Non-Small-Cell Lung · AstraZeneca.
Among the 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca, this one is the 21st largest by planned enrollment of the 67 observational ones that give a count, is one of 20 that started in 2024, is one of 67 observational ones, reaches primary completion later than 68 of the 77 other live ones, and was the 186th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →25 of the 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in China
Ages 18+
AstraZeneca · Sites in China
Ages 18+
AstraZeneca · Sites in China
Ages 18+
AstraZeneca · Sites in China
Ages 18+
AstraZeneca · Sites in Australia, Georgia, Poland and 2 more countries
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years to 120 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
209 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 48 · Phase 3 44 · Phase 4 10
First in 2000; this study’s year is marked. 20 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 600 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 152 across the 137 interventional studies, 350 across the 67 observational. Of the 123 that completed or were terminated, 45 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
16 of the studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05221840Phase 3AstraZenecaA Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer | 2027-01-08 |
| NCT06417814Phase 3AstraZenecaA Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 2027-01-11 |
| NCT05120349Phase 3AstraZenecaA Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection | 2027-08-02 |
| NCT05687266Phase 3AstraZenecaPhase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations | 2027-11-01 |
| NCT05456867AstraZenecaA Multi-center, Non-interventional, Prospective Study of Durvalumab in Unresectable Locally Advanced NSCLC in Routine Clinical Practice in Russia | 2026-11-30 |
Add all 16 to your calendar (.ics) → With an account.
Among the 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This study also gives Durvalumab, Tremelimumab. No intervention listed here names it: that was found by reading the record.
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
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
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.
Time frame: 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.
Access criteria: 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.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Dec 2029, 66 months after the start.
Of 142 industry-sponsored observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 64. This study's planned 66 months is above that.
Counting every sponsor, half of 498 studies reached it within 55 months; a quarter within 35 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Carcinoma, Non-Small-Cell Lung →