Endometrial CancerDUOLifeNCT06890273
NIS to Examine the Effectiveness and Safety of Durvalumab and Olaparib in Patients With Endometrial Cancer (DUOLife)
An observational study of Endometrial Cancer, run by AstraZeneca at 49 sites in Germany.
Trial summary
This is a German multi-center, prospective, non-interventional study (NIS) to collect real-world clinical data in patients with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer (EC) receiving first-line (1L) regimens with Carboplatin/Paclitaxel/Durvalumab (CPD) followed by maintenance therapy… Read more about this study
- Who is it for?
- Ages 18 to 130 years, women only
- Conditions the study is for
- Endometrial Cancer
- How many people
- 150 participants
- Where
- 49 sitesGermany
- Study dates
- 20 May 2025to 31 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 150 patients with documented primary advanced (FIGO stage III or IV) or recurrent EC of epithelial histology (excluding sarcomas) who are eligible for first-line therapy with CPD followed by durvalumab or durvalumab and olaparib in line with the applicable SmPC within routine clinical practice will be recruited in Germany. The study allows recruitment of patients that already started and may have received up to 2 cycles of CPD. Inclusion of patients having started CPD will be capped to 25% for each cohort of the study population. Testing results for MMR status of the patients' tumor must be available. Patients must be willing and able to report PROs. Eligible patients will be included into the study after and independently of the treating physician's treatment and diagnostic decisions.
Who may be able to join
- Women aged ≥ 18 years at the time of screening.
- Patient has pathologically documented:
- Primary advanced (FIGO III and IV) epithelial EC OR
- Recurrent disease that is unlikely to be cured and where the multidisciplinary tumor board decision is systemic therapy. Carcinosarcomas are allowed,
- Patient is intended or initiated to receive 1L CPD followed by maintenance therapy with durvalumab (dMMR cohort) or with durvalumab and olaparib (pMMR cohort) according to the SmPC of IMFINZI® and Lynparza®* prior to enrollment. Recruitment of patients that already started and may have received up to 2 cycles of CPD is allowed but will be capped to 25% for each cohort of the study population.
- Patient is eligible for treatment with durvalumab and/or olaparib as specified in the IMFINZI® and Lynparza® SmPC. The prescription of the medicinal product is clearly separated from the decision to include the patient in the study.
Show all 10Show fewer
- MMR-testing results of the patient's tumor are known.
- Patient is willing and able to complete PRO questionnaires.
- Patient can read and understand German, English, Arab, Russian or Turkish.
- Signed written informed consent.
Who cannot join
- Patient has already received >2 cycles of 1L CPD
- Known hypersensitivity to carboplatin, paclitaxel, durvalumab and/or olaparib or any of the excipients of the drug.
- Pregnancy or breast-feeding.
- Unable to swallow orally administered medication.
- Current or planned participation in an interventional clinical trial.
- Current or planned systemic treatment of any tumor other than primary advanced or recurrent EC.
- Patient has pathologically documented sarcoma
Trial locations and contacts
49 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
49 sites in 1 country
Germany49 sites, 49 recruiting
- Recruiting
Research Site
Amberg
- Recruiting
Research Site
Bad Nauheim
- Recruiting
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Bautzen
- Recruiting
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Berlin
- Recruiting
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Bielefeld
- Recruiting
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Bonn
- Recruiting
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Borna
- Recruiting
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Bottrop
- Recruiting
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Brandenburg an der Havel
- Recruiting
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Braunschweig
- Recruiting
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Cologne
- Recruiting
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Dessau
- Recruiting
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Dresden
- Recruiting
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Ebersberg
- Recruiting
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Eggenfelden
- Recruiting
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Essen
- Recruiting
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Goslar
- Recruiting
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Greifswald
- Recruiting
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Gütersloh
- Recruiting
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Hamburg
- Recruiting
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Heilbronn
- Recruiting
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Homburg
- Recruiting
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Hösbach
- Recruiting
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Kiel
- Recruiting
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Krefeld
- Recruiting
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Kulmbach
- Recruiting
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Landshut
- Recruiting
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Leipzig
- Recruiting
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Limburg
- Recruiting
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Lüneburg
- Recruiting
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Magdeburg
- Recruiting
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Mainz
- Recruiting
Research Site
München
- Recruiting
Research Site
Neuruppin
- Recruiting
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Neuss
- Recruiting
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Nuremberg
- Recruiting
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Plauen
- Recruiting
Research Site
Rotenburg (Wümme)
- Recruiting
Research Site
Siegen
- Recruiting
Research Site
Solingen
- Recruiting
Research Site
Stendal
- Recruiting
Research Site
Torgau
- Recruiting
Research Site
Traunstein
- Recruiting
Research Site
Unna
- Recruiting
Research Site
Wernigerode
- Recruiting
Research Site
Winnenden
- Recruiting
Research Site
Witten
- Recruiting
Research Site
Worms
- Recruiting
Research Site
Zittau
About this study
Official title: Prospective NIS to Generate Real-World-Data on Effectiveness and Safety of First-line Therapy With Chemotherapy Combined With Durvalumab Followed by Maintenance Therapy With Durvalumab or Durvalumab + Olaparib in Endometrial Cancer
This is a German multi-center, prospective, non-interventional study (NIS) to collect real-world clinical data in patients with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer (EC) receiving first-line (1L) regimens with Carboplatin/Paclitaxel/Durvalumab (CPD) followed by maintenance therapy with durvalumab or durvalumab and olaparib in line with the applicable european summary of product characteristics (SmPC). Additionally, patient-reported outcomes after 1L treatment with CPD will be assessed.
Read the detailed description
This is a multi-center, prospective, non-interventional study (NIS) to collect real-world clinical and PRO data in patients with primary advanced (FIGO stage III or IV) or recurrent EC receiving 1L CPD followed by maintenance therapy with durvalumab (DNA mismatch repair deficient; dMMR cohort) or durvalumab and olaparib (DNA mismatch repair proficient, pMMR cohort) in accordance with the applicable SmPC within routine clinical practice. Following surgery and/or radiation (if applicable) the decision to initiate 1L CPD followed by durvalumab or durvalumab and olaparib is made in a shared decision between the patient and the treating physician as part of routine care outside of and independent of this study.
The aim of the NIS is to describe the outcomes including effectiveness and safety of patients with primary advanced and recurrent EC treated with the two approved 1L regimens of CPD followed by durvalumab maintenance and CPD followed by durvalumab and olaparib maintenance, as well as patient-reported outcomes after chemotherapy-phase (CPD) in Germany. The study also aims to better understand characteristics of patients with primary advanced or recurrent EC that benefit from maintenance therapy with durvalumab or durvalumab and olaparib.
- Conditions
- Endometrial Cancer
- Keywords
- Durvalumab, Olaparib, Primary advanced endometrial cancer (1L), FIGO III or IV, Recurrent endometrial cancer (1L), dMMR, pMMR, Real-World Evidence, Patient-Reported Outcome
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DNA mismatch repair deficient (dMMR) | Patients with primary advanced or recurrent endometrial cancer receiving 1L regimens of CPD with prior tested dMMR status. Following the SmPC patients of this cohort will receive durvalumab in the maintenance phase if they achieved and maintained disease control, i.e., complete response (CR), partial response (PR), or stable disease (SD) with CPD during the chemotherapy phase. | |
| DNA mismatch repair proficient (pMMR) | Patients with primary advanced or recurrent endometrial cancer receiving 1L regimens of CPD with prior tested pMMR status. Following the SmPC patients of this cohort will receive durvalumab and olaparib in the maintenance phase if they achieved and maintained disease control i.e., CR, PR, or SD with CPD during the chemotherapy phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world Time To Next Treatment (rwTTNT)
rwTTNT is defined as time from start of 1L CPD until first dose of next systemic therapy or start of any other next anticancer therapy or death from any cause.
1L maintenance therapy with durvalumab or durvalumab+olaparib is not considered as next systemic therapy.
The measure of interest is the landmark at 12 months of time to first next therapy or death (rwTTNT).
Measured: At 12 months
Secondary outcomes (7)
Real-world Progression-free Survival (rwPFS)
rwPFS is defined as time from start of 1L CPD until progression or death from any cause.
The measure of interest is the landmark at 12 months of progression-free survival (rwPFS).
Measured: At 12 months
Time to deterioration in health-related quality of life (HRQoL) based on EORTC QLQ-C30 questionnaire compared to baseline over time
The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30), is a validated 30-item self-administered core questionnaire designed to assess HRQoL, functioning, and symptoms in all cancer patients or survivors.
Time to deterioration is defined as time from baseline (≤ 14 days before first application of maintenance therapy) to date of first clinically meaningful deterioration i.e. a decrease by ≥10 points for the functional scales and an increase by ≥ 10 points for the symptom scales or death in:
- Physical functioning score
- Role functioning score
Measured: Baseline to first clinically meaningful deterioration, up to 46 months
Time to deterioration in HRQoL based on EORTC QLQ-EN24 questionnaire compared to baseline over time
The Endometrial Cancer Module EORTC QLQ-EN24, is a validated disease-specific extension to the EORTC QLQ-C30 designed to assess disease and treatment specific aspects of the QoLof patients with all stages of EC. The module consists of 24 questions grouped into 13 scales.
Time to deterioration is defined as time from baseline (≤ 14 days before first application of maintenance therapy) to date of first clinically meaningful deterioration i.e. a decrease by ≥10 points for the functional scales and an increase by ≥ 10 points for the symptom scales or death in:
- Back/pelvic pain
- Gastrointestinal (GI) symptoms
- Urological symptoms
Measured: Baseline to first clinically meaningful deterioration, up to 46 months
Duration of maintenance therapy
Time from first dose of maintenance therapy with durvalumab or durvalumab+olaparib to the last dose/cyle of durvalumab or olaparib, whatever is last, including number and duration of treatment interruptions.
Measured: From first dose of maintenance therapy up to 46 months
Duration of 1L CPD
Duration of therapy with durvalumab with carboplatin and/or paclitaxel
Measured: Assessed up to 46 months
Time between end of CPD until start of maintenance therapy
Time to start maintenance therapy defined as date of last cycle of chemotherapy until date of first dose of maintenance therapy
Measured: Assessed up to 46 months
Usage of treatment therapy
Dose, dose change, treatment interruption, number of cycles, cumulative dose of durvalumab.
Measured: Assessed up to 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start20 May 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- North-Eastern German Society of Gynecological Oncology (NOGGO e.V.)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890273
- Sponsor's protocol ID
- D9311R00001
- Acronym
- DUOLife
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective NIS to Generate Real-World-Data on Effectiveness and Safety of First-line Therapy With Chemotherapy Combined With Durvalumab Followed by Maintenance Therapy With Durvalumab or Durvalumab + Olaparib in Endometrial Cancer
- ClinicalTrials.gov ID
- NCT06890273
- Acronym / sponsor ID
- DUOLife / D9311R00001
- Conditions
- Endometrial Cancer
- Keywords
- Durvalumab, Olaparib, Primary advanced endometrial cancer (1L), FIGO III or IV, Recurrent endometrial cancer (1L), dMMR, pMMR, Real-World Evidence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- North-Eastern German Society of Gynecological Oncology (NOGGO e.V.)
- Study start
- 20 May 2025 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a German multi-center, prospective, non-interventional study (NIS) to collect real-world clinical data in patients with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer (EC) receiving first-line (1L) regimens with Carboplatin/Paclitaxel/Durvalumab (CPD) followed by maintenance therapy with durvalumab or durvalumab and olaparib in line with the applicable european summary of product characteristics (SmPC). Additionally, patient-reported outcomes after 1L treatment with CPD will be assessed.
Detailed description
This is a multi-center, prospective, non-interventional study (NIS) to collect real-world clinical and PRO data in patients with primary advanced (FIGO stage III or IV) or recurrent EC receiving 1L CPD followed by maintenance therapy with durvalumab (DNA mismatch repair deficient; dMMR cohort) or durvalumab and olaparib (DNA mismatch repair proficient, pMMR cohort) in accordance with the applicable SmPC within routine clinical practice. Following surgery and/or radiation (if applicable) the decision to initiate 1L CPD followed by durvalumab or durvalumab and olaparib is made in a shared decision between the patient and the treating physician as part of routine care outside of and independent of this study.
The aim of the NIS is to describe the outcomes including effectiveness and safety of patients with primary advanced and recurrent EC treated with the two approved 1L regimens of CPD followed by durvalumab maintenance and CPD followed by durvalumab and olaparib maintenance, as well as patient-reported outcomes after chemotherapy-phase (CPD) in Germany. The study also aims to better understand characteristics of patients with primary advanced or recurrent EC that benefit from maintenance therapy with durvalumab or durvalumab and olaparib.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DNA mismatch repair deficient (dMMR) | – | –Patients with primary advanced or recurrent endometrial cancer receiving 1L regimens of CPD with prior tested dMMR status. Following the SmPC patients of this cohort will receive durvalumab in the maintenance phase if they achieved and maintained disease control, i.e., complete response (CR), partial response (PR), or stable disease (SD) with CPD during the chemotherapy phase. |
| DNA mismatch repair proficient (pMMR) | – | –Patients with primary advanced or recurrent endometrial cancer receiving 1L regimens of CPD with prior tested pMMR status. Following the SmPC patients of this cohort will receive durvalumab and olaparib in the maintenance phase if they achieved and maintained disease control i.e., CR, PR, or SD with CPD during the chemotherapy phase. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 patients with documented primary advanced (FIGO stage III or IV) or recurrent EC of epithelial histology (excluding sarcomas) who are eligible for first-line therapy with CPD followed by durvalumab or durvalumab and olaparib in line with the applicable SmPC within routine clinical practice will be recruited in Germany. The study allows recruitment of patients that already started and may have received up to 2 cycles of CPD. Inclusion of patients having started CPD will be capped to 25% for each cohort of the study population. Testing results for MMR status of the patients' tumor must be available. Patients must be willing and able to report PROs. Eligible patients will be included into the study after and independently of the treating physician's treatment and diagnostic decisions.
Key inclusion criteria (10 listed)
- Women aged ≥ 18 years at the time of screening.
- Patient has pathologically documented:
- Primary advanced (FIGO III and IV) epithelial EC OR
- Recurrent disease that is unlikely to be cured and where the multidisciplinary tumor board decision is systemic therapy. Carcinosarcomas are allowed,
- Patient is intended or initiated to receive 1L CPD followed by maintenance therapy with durvalumab (dMMR cohort) or with durvalumab and olaparib (pMMR cohort) according to the SmPC of IMFINZI® and Lynparza®* prior to enrollment. Recruitment of patients that already started and may have received up to 2 cycles of CPD is allowed but will be capped to 25% for each cohort of the study population.
Key exclusion criteria (7 listed)
- Patient has already received >2 cycles of 1L CPD
- Known hypersensitivity to carboplatin, paclitaxel, durvalumab and/or olaparib or any of the excipients of the drug.
- Pregnancy or breast-feeding.
- Unable to swallow orally administered medication.
- Current or planned participation in an interventional clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Real-world Time To Next Treatment (rwTTNT)
Time frame: At 12 months
rwTTNT is defined as time from start of 1L CPD until first dose of next systemic therapy or start of any other next anticancer therapy or death from any cause. 1L maintenance therapy with durvalumab or durvalumab+olaparib is not considered as next systemic therapy. The measure of interest is the landmark at 12 months of time to first next therapy or death (rwTTNT).
7 secondary outcomes
Real-world Progression-free Survival (rwPFS)
Time frame: At 12 months
Time to deterioration in health-related quality of life (HRQoL) based on EORTC QLQ-C30 questionnaire compared to baseline over time
Time frame: Baseline to first clinically meaningful deterioration, up to 46 months
Time to deterioration in HRQoL based on EORTC QLQ-EN24 questionnaire compared to baseline over time
Time frame: Baseline to first clinically meaningful deterioration, up to 46 months
Duration of maintenance therapy
Time frame: From first dose of maintenance therapy up to 46 months
Duration of 1L CPD
Time frame: Assessed up to 46 months
Time between end of CPD until start of maintenance therapy
Time frame: Assessed up to 46 months
Usage of treatment therapy
Time frame: Assessed up to 46 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Cancer, run by AstraZeneca at 49 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world Time To Next Treatment (rwTTNT) (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.