NCT06890273 NIS to Examine the Effectiveness and Safety of Durvalumab and Olaparib in Patients With Endometrial Cancer (DUOLife)
| NCT ID | NCT06890273 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Endometrial Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-05-20 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06890273 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 130 Years, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06890273 currently recruiting?
Yes, NCT06890273 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06890273 trial being conducted?
This trial is being conducted at Amberg, Germany, Bad Nauheim, Germany, Bautzen, Germany, Berlin, Germany and 11 additional locations.
Who is sponsoring the NCT06890273 clinical trial?
NCT06890273 is sponsored by AstraZeneca. The trial plans to enroll 150 participants.
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