NCT06890273Recruiting
NIS to Examine the Effectiveness and Safety of Durvalumab and Olaparib in Patients With Endometrial Cancer (DUOLife)
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
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 17 Mar 2025
- Start date
- 20 May 2025
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- AstraZeneca
- Diseases
- Endometrial cancer
- NCT number
- NCT06890273
What you commit to
- Study type: Observational
- Planned participants: 150
- From 20 May 2025 to the primary completion date, 31 Mar 2029
- 49 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient has already received \>2 cycles of 1L CPD
- Unable to swallow orally administered medication.
Other illness
- Known hypersensitivity to carboplatin, paclitaxel, durvalumab and/or olaparib or any of the excipients of the drug.
Other
- Pregnancy or breast-feeding.
- 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
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to 130 years · Sex: Female · Does not accept healthy volunteers
Sites (49)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.